Analytical device

Abstract

This provides an analysis system that can be easily performed by analysts without specialized knowledge and has a small or simple structure. [Solution] An analytical apparatus (1) for analyzing a specific component in a sample taken from an object to be analyzed, comprising: a sample storage unit (52b) for storing the sample or a sample-containing element containing the sample; an extraction unit (52c) connected to the sample storage unit and for extracting the specific component from the sample or sample-containing element stored in the sample storage unit into a fluid to obtain a fluid sample; a reagent storage unit (526b, 527b, 528b) for storing liquid or powder reagents; and a reagent addition unit (52b, 52c) for adding the reagent to the fluid when the extraction unit extracts the specific component into the fluid.

Description

Technical Field

[0001] The present invention relates to an analyzer for analyzing specific components in a test substance.

Background Art

[0002] In recent years, due to the improvement of anti-aging and health care awareness, the number of people using nutritional supplements and health cosmetics has been increasing. In order to more effectively ingest these supplements, it is important to continuously grasp the biological information derived from daily living habits. However, information obtained from outside the body such as a scale, a sphygmomanometer, electromyogram, electrocardiogram, and pulse is insufficient, and it is important to grasp the internal state such as the state of nutritional components and biological metabolites lacking in the body and changes in the balance of multiple biological components.

[0003] In order to realize tailor-made health care based on the wet component information in the body, a liquid chromatograph device is often used to analyze the components contained in body fluids (blood, urine, tears, saliva, sweat, etc.) secreted and excreted inside and outside the body. However, in conventional devices, advanced expertise is required for analysts, the location for analysis is limited to research facilities, etc., and it has been difficult to reduce the cost for analysis. In addition, the device itself is expensive and large, and in this sense, the analysis location is also limited and the cost has been increasing. In addition to the analysis of biological components as described above, the demand for on-site environmental measurement devices for analyzing specific components such as nutrients contained in soil, rivers, and the liquid in plant factories has been increasing.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

[0005] This invention has been made in view of the above circumstances, and its objective is to provide an analytical device that can be easily used by analysts without specialized knowledge and has a small or simple structure. [Means for solving the problem]

[0006] To achieve the aforementioned objective, this disclosure adopts the following configuration: an analytical apparatus for analyzing specific components in a sample taken from an object to be analyzed, An inspection object storage unit for storing the inspection object or an inspection object containing the inspection object, An extraction unit is connected to the inspection object storage unit and extracts the specific component from the inspection object or the inspection object-containing element stored in the inspection object storage unit into a fluid to obtain a fluid sample, A reagent storage section for storing liquid or powdered reagents, During the extraction of the specific component into the fluid by the extraction unit, the reagent addition unit adds the reagent to the fluid, This analytical device is characterized by having the following features.

[0007] According to this disclosure, in the process in which the extraction unit extracts a specific component from the test object or a test object-containing element into a fluid, the reagent addition unit can simultaneously add the necessary reagent to the fluid. Therefore, the fluid containing the component to be analyzed and the necessary reagent can be efficiently added. It is possible to prepare body samples.

[0008] Furthermore, in this disclosure, the reagent is a liquid reagent, and the reagent storage unit is a container provided in the test sample storage unit that stores the liquid reagent. When the sample storage section and the extraction section are joined, the container may rupture, causing the reagent to be added to the fluid.

[0009] According to this, in the process of extracting a specific component from the test object or test object-containing element stored in the test object storage unit into a fluid, it is possible to automatically add a reagent to the fluid. Therefore, it is possible to prepare a fluid sample containing both the specific component of the test object and the reagent more efficiently.

[0010] Furthermore, in this disclosure, the reagent is a powdered reagent, and the reagent storage section is a part provided in the test material storage section for storing the powdered reagent. When the extraction unit extracts the specific component into the fluid, the fluid may flow into the inspection object storage unit so as to come into contact with the inspection object or the inspection object containing the inspection object, and also come into contact with the powdered reagent in the reagent storage unit, thereby adding the reagent to the fluid.

[0011] According to this method, by introducing a fluid into the object storage compartment and extracting specific components from the object or object-containing element stored in the compartment into the fluid, it is possible to simultaneously add the necessary reagents to the fluid. Therefore, it is possible to prepare a fluid sample containing both the specific components of the object and the reagents more efficiently.

[0012] Furthermore, in this disclosure, the inspection material storage unit is sealed before use, and the sealed state may be released by opening it when the extraction unit extracts the specific component into the fluid.

[0013] According to this, the sample storage section, which is provided with a part for storing powdered reagents, is sealed before use and opened when in use. Therefore, it is possible to prevent the powdered reagents from detaching from the sample storage section before use and to prevent deterioration of the powdered reagents.

[0014] Furthermore, in this disclosure, the reagent storage section may be a reagent-containing element provided in the test material storage section, containing a solution with the powdered reagent and then dried. This allows the reagent to dissolve and be supplied to the fluid upon contact with the reagent-containing element. This makes it easier to store reagents that require strict storage conditions in a liquid state for extended periods. It also allows for the accurate addition of minute amounts of powdered reagents, which are difficult to measure and handle, to the fluid. The reagent-containing element can be made from various materials, including paper such as filter paper, fiber materials, and mesh-structured resin materials, all capable of containing a solution with the powdered reagent.

[0015] Furthermore, in this disclosure, the extraction unit is provided with an ultrasonic generator that generates ultrasonic waves. During the extraction of the specific component into the fluid by the extraction unit, the ultrasonic generator may apply ultrasonic waves to the object being inspected or the element containing the object being inspected in the object storage unit.

[0016] According to this method, when a fluid is introduced into the inspection object storage compartment and specific components are extracted into the fluid from the inspection object or element containing the inspection object stored in the inspection object storage compartment, it is possible to extract the specific components more efficiently by applying ultrasound to the inspection object or element containing the inspection object.

[0017] Furthermore, in this disclosure, the ultrasonic generator may also apply the ultrasound to the fluid sample from which the specific component has been extracted by the extraction unit and to which the reagent has been added by the reagent addition unit.

[0018] According to this method, specific components are extracted, and by applying ultrasound to the fluid sample to which reagents have been added via the reagent addition section, mixing is promoted, and if cells are present, the cells are destroyed, making it possible to extract specific components more reliably. Furthermore, by generating nanobubbles in the fluid sample with ultrasound, mixing can be promoted even further.

[0019] In addition, in the present disclosure, the test object storage unit includes a test object chamber for storing the test object or the test object-containing element, an inflow passage for allowing the fluid to flow into the test object chamber, and an outflow passage for allowing the fluid to flow out of the test object chamber. The extraction unit is provided with a second outflow passage through which the fluid before extraction of the specific component flows out, and a second inflow passage into which the fluid after extraction of the specific component flows in. When the test object storage unit and the extraction unit are coupled, the inflow passage and the second outflow passage communicate with each other, and the outflow passage and the second inflow passage communicate with each other, so that the fluid before extraction of the specific component may be allowed to flow into the test object chamber.

[0020] According to this, by simply performing the operation of coupling the test object storage unit and the extraction unit, the fluid can be allowed to flow into the test object storage unit, and the extraction of the specific component can be efficiently performed.

[0021] In addition, in the present disclosure, an analyzer for analyzing a specific component in a test object, a pretreatment unit that performs pretreatment for enabling detection of the specific component on the test object collected from the analysis target, an analysis unit that analyzes the specific component on the test object subjected to the pretreatment, and the pretreatment unit includes a test object storage unit that stores the test object or a test object-containing element including the test object, an extraction unit that extracts the specific component into a fluid from the test object or the test object-containing element stored in the test object storage unit to obtain a fluid sample, a reagent storage unit that stores a liquid or powder reagent, a reagent addition unit that adds the reagent into the fluid, and a pretreatment cassette mounting unit that mounts an exchangeable pretreatment cassette, and at least a part of the functions of the test object storage unit, the extraction unit, the reagent storage unit, and the reagent addition unit is housed in the pretreatment cassette mounted on the pretreatment cassette mounting unit. The analysis unit A measuring unit for detecting or measuring the specific component in the fluid sample from which the specific component has been extracted and to which the reagent has been added, It has an analysis cassette mounting section into which an analysis cassette is attached, which is replaceable and detects and analyzes the specific components contained in the fluid sample. At least a part of the functions of the measurement unit are housed in the analysis cassette mounted on the analysis cassette mounting unit. The system may further include a sample supply unit that supplies the fluid sample, which has been pre-treated in the pre-processing unit, to the analysis unit.

[0022] According to this system, by appropriately changing the pre-treatment cassette, it is possible to perform various types of pre-treatment on specific components extracted from the test sample. Furthermore, by changing the analysis cassette, it is possible to perform various types of analysis. In addition, the sample supply unit makes it possible to efficiently supply the fluid sample that has been pre-treated in the pre-treatment cassette to the analysis cassette. .

[0023] Furthermore, in this disclosure, in the analytical apparatus, the preprocessing unit is located above the analytical unit. The aforementioned sample supply unit is The pre-treated fluid sample in the aforementioned pre-processing unit is dropped by a nozzle under its own weight, A receiving unit that receives the dropped fluid sample and supplies it to the analysis unit, It may also be included.

[0024] According to this method, the fluid sample, which has been pre-treated in the pre-processing unit, can be supplied to the analysis cassette without the use of any special mechanisms, through a simple mechanism in which the fluid sample is dropped from the nozzle to the receiving unit. Furthermore, the solvent can be evaporated while the droplet expands at the nozzle tip before falling, making it possible to increase the concentration of specific components in the fluid sample.

[0025] Furthermore, in this disclosure, a predetermined potential difference may be provided between the nozzle and the receiving portion in the sample supply unit. This allows the charged droplet of the fluid sample to be attracted by the electric field between the nozzle and the receiving portion, causing the droplet at the nozzle tip to fall toward the receiving portion while it is still small. As a result, the ratio of surface area to volume in the falling droplet can be increased, making it possible to more reliably increase the concentration of specific components in the fluid sample.

[0026] Furthermore, in this disclosure, the tip of the nozzle may be divided into a narrower tip nozzle. This makes it easier to drop the droplets growing at the nozzle tip, further increases the ratio of surface area to volume in the dropping droplets, and more reliably increases the concentration of specific components in the fluid sample.

[0027] Furthermore, this disclosure relates to an analytical device for analyzing specific components in a test sample, A preprocessing unit that performs preprocessing on the sample taken from the object to be analyzed to enable the detection of the specific component, The system includes an analysis unit that performs analysis of the specific components in the sample that has undergone the aforementioned pretreatment, The aforementioned pre-processing unit, The unit has an extraction section that extracts the specific component from the inspected object or an inspected object-containing element containing the inspected object into a fluid to obtain a fluid sample. The aforementioned analysis unit is The measuring chip contains a measuring reagent that reacts with the aforementioned specific component to produce a specific color, In the aforementioned measurement chip, multiple types of measurement reagents, each reacting with multiple types of the aforementioned specific components, are contained in different locations. The system may further include an imaging unit capable of simultaneously capturing colors at different locations.

[0028] According to this, it is possible to analyze multiple specific components with a single image taken by the imaging unit. Furthermore, it includes mechanisms such as an XY stage for capturing the color-developing locations on the measurement chip one by one. This eliminates the need for [specific equipment / method], and furthermore, eliminates the need for equipment for separation and analysis, making it possible to miniaturize and reduce the cost of the device.

[0029] Furthermore, each of the above configurations and processes can be combined with each other to constitute the present invention, provided that no technical inconsistencies arise. [Effects of the Invention]

[0030] According to the present invention, analysis can be easily performed by analysts without specialized knowledge, and an analytical device with a small or simple structure can be realized. [Brief explanation of the drawing]

[0031] [Figure 1] This diagram shows a schematic representation of conventional methods for analyzing biological components. [Figure 2] This is a conceptual diagram of the measurement principle in the liquid chromatograph apparatus described herein. [Figure 3] This is an example of a biological component obtained by a liquid chromatography apparatus as described in this disclosure. [Figure 4] This figure shows a schematic diagram of the method for analyzing biological components according to the embodiments of this disclosure. [Figure 5] This is a block diagram of an analytical apparatus according to an embodiment of the present disclosure. [Figure 6] This figure shows the specific structure of the pre-processing unit according to an embodiment of the present disclosure. [Figure 7] This figure shows a patch holder for a holding mechanism according to an embodiment of the present disclosure. [Figure 8] This is a more detailed diagram illustrating the holding mechanism according to an embodiment of the present disclosure. [Figure 9] This figure shows a mechanism for adding reagents to a pretreatment solution according to an embodiment of the present disclosure. [Figure 10] This figure illustrates the function of an ultrasonic generator according to an embodiment of the present disclosure. [Figure 11] This is an explanatory diagram of another embodiment of the holding mechanism according to the embodiment of the present disclosure. [Figure 12] This is an explanatory diagram of a microfluidic chip according to an embodiment of the present disclosure. [Figure 13] This figure shows the specific structure of the analysis unit according to the embodiment of the present disclosure. [Figure 14] This is a schematic configuration of a pillar array column used in an analytical chip according to the embodiment of this disclosure. [Figure 15] This is an example of a schematic configuration of a detection optical system according to an embodiment of the present disclosure. [Figure 16] This figure shows an example of an enzyme reaction chip according to the embodiments of the present disclosure. [Figure 17] This figure shows another example of an enzyme reaction chip according to the embodiments of this disclosure. [Figure 18] This is a schematic diagram of a first example of a sample supply unit according to the embodiments of the present disclosure. [Figure 19] This is a schematic diagram of a second example of a sample supply unit according to the embodiments of the present disclosure. [Figure 20] This is a schematic diagram of a third example of a sample supply unit according to the embodiments of this disclosure. [Modes for carrying out the invention]

[0032] <Examples> Embodiments of the present invention will be described below with reference to the drawings. However, unless otherwise specified, the scope of this invention is not limited to the components described in each of the following examples.

[0033] Figure 1 outlines a conventional method for analyzing biological components (amino acids, proteins, bases, lipids, extracellular vesicles, etc.) as an example of specific components. In the conventional analysis method, first, blood is collected from the subject 2 as an example of the test material. The collection method may be, for example, as shown in Figure 1, by collecting blood from the subject 2 using a syringe. Then, as shown in the center of Figure 1, biological components are extracted from the blood as the test material by hand, and pre-processing is performed to enable analysis, thereby generating a liquid sample as a fluid sample. The liquid sample is then analyzed in the analyzer 5. Subsequently, the analysis results are provided to medical institutions or directly to users in the form of paper or electronic data as appropriate.

[0034] Figure 2 shows a conceptual diagram of the measurement principle in a liquid chromatograph apparatus 110, which is an example of a conventional analytical instrument 5. In Figure 2, the column (stationary phase) 120 has a structure in which a carrier such as diatomaceous earth is filled in a container. In the aforementioned pretreatment step, a liquid sample 122, which is produced by, for example, fluorescent modification of biological components in blood as the test material, is passed through the sample path 120a in the column 120. In liquid chromatography, a mobile phase 121, which is a liquid for separating biological components in sweat, is flowed through the column 120. This mobile phase 121 is transported at a constant speed through the column 120 (stationary phase) from the sample introduction section 120b to the detection section 120d by a liquid delivery pump (not shown).

[0035] The liquid sample 122 is then injected into the sample introduction section 120b of the column 120 and carried along by the flow of the mobile phase 121 in the column 120. As a result, the biological components in the liquid sample move through the separation section 120c in the column 120 due to the flow of the mobile phase 121. Since the movement speed differs depending on the type of biological component, the biological components are separated by type in the separation section 120c. Each separated biological component is detected by detecting the fluorescence generated in each biological component by excitation light irradiated from the light source 123 using a photodetector 124. The type of each biological component is then identified by the detection time in the detection section 120d, and the amount of each biological component is detected from the fluorescence intensity. As a result, qualitative and quantitative analysis of the types of biological components becomes possible. In addition to, or instead of, fluorescence detection of biological components in the detection section 120d, analysis such as mass spectrometry may be performed using an external detector 125.

[0036] Figure 3 shows an example of a biocomponent profile obtained by the liquid chromatograph apparatus 110. The horizontal axis in Figure 3 represents the time each type of biocomponent is retained in the column 120, corresponding to the migration speed of each type of biocomponent. The vertical axis in Figure 3 represents the signal intensity (fluorescence intensity, etc.) detected by the detection unit 120d, corresponding to the amount of each type of biocomponent.

[0037] However, with the conventional analysis using the aforementioned analytical device 5 (liquid chromatograph 110), the analyst needed specialized knowledge of how to handle the equipment and the measurement principles. Consequently, it was necessary to send the collected samples to research facilities for pretreatment and analysis, which resulted in high labor costs. Furthermore, the analysis itself using analytical device 5 (liquid chromatograph 110) was time-consuming. As a result, it was difficult for users to easily and quickly obtain information regarding the analysis results of biological components.

[0038] Figure 4 outlines the method for analyzing biological components in this embodiment. In this embodiment, the case where the analyte 2 is a human being is described. However, the analyte 2 is not limited to humans; it may also be an animal other than a human. Furthermore, soil, rivers, plant factories, etc., may also be used as the analyte.

[0039] In the analytical method of this embodiment, first, sweat from the subject of analysis 2 is collected as an example of the test material. As shown in Figure 4, the sweat may be collected from the skin of the subject of analysis 2 using a hygroscopic patch 3. Here, hygroscopic means either or both of the properties of water absorption and oil absorption. Then, in the pre-processing unit 10 of the analytical device 1, biological components are extracted from the sweat as the test material, and pre-processing is performed to enable analysis, thereby generating a liquid sample. Then, the liquid sample is analyzed in the analysis unit 20. In this embodiment, the analysis unit 20 may use liquid chromatography as the measurement principle, or it may utilize the enzymatic reaction of a paper device as described later. Furthermore, changes in the intensity of a specific wavelength due to fluorescence, emission, or absorption by the liquid sample may also be measured.

[0040] Subsequently, in this embodiment, the results of the analysis and accompanying information may be provided to the user in a manner such as shown on display screen 7. In this embodiment, an example using patch 3 as a sampler for collecting the sample is described, but the sweat sample may be collected by other methods. For example, a method of direct collection using a collection liquid is conceivable. Here, the collection liquid means water, an organic solvent, or a mixture prepared with other components. This point is also true in the following descriptions of this specification. Furthermore, the sample in this disclosure is not limited to sweat. Blood, urine, tears, saliva, and hair can also be used as samples; the most suitable collection method should be selected according to the specific sample being tested.

[0041] In Figure 4, the analysis results are provided to the user by displaying them on a smartphone or other device, but the method of using the information is not limited to this. Furthermore, while the present invention describes an example of analyzing amino acids in sweat as biological components, this disclosure also includes collecting and analyzing proteins other than amino acids, bases, lipids, extracellular vesicles, etc., as biological components.

[0042] Figure 5 shows a block diagram of the analyzer 1 in this embodiment. The analyzer 1 includes a pre-processing unit 10 and an analysis unit 20. The pre-processing unit 10 is the part that performs the necessary pre-treatment on the sweat sample collected from the object to be analyzed 2, and generates a liquid sample that can be detected by the analysis unit 20. As mentioned above, an example of pre-treatment in this embodiment is the fluorescent modification of amino acids in the sweat. The pre-processing unit 10 is equipped with a detachable pre-treatment cassette 50 that contains most of the equipment and chemical solutions necessary for this pre-treatment.

[0043] Furthermore, the analysis unit 20 is detachably equipped with an analysis cassette 60 containing most of the instruments and chemicals for analyzing the pre-treated liquid sample. Automatic analysis of the liquid sample is possible within this analysis cassette 60. Thus, in the analysis apparatus 1 of this embodiment, the analyst does not need to perform specific pre-treatment tasks. Nor does the analyst need to perform specific tasks for analyzing the liquid sample. Therefore, an analyst without specialized knowledge can easily analyze amino acids in sweat.

[0044] Furthermore, various analytical methods can be selected in the analyzer 1. An analytical cassette 60 equipped with the optimal instruments and chemicals for the selected analytical method, and a pre-treatment cassette 50 capable of performing pre-treatment to enable analysis in the analytical cassette 60 are selected and installed in the analyzer 1. The analyzer 1 also includes a sample supply unit 59 for supplying the liquid sample, which has been pre-treated in the pre-treatment unit 10, to the analytical cassette 60 of the analysis unit 20.

[0045] Figure 6 shows the specific structure of the pre-processing unit 10 in the analytical apparatus 1 of this embodiment. The pre-processing unit 10 is provided with a pre-processing cassette mounting section 50a, which is a mechanism for mounting the pre-processing cassette 50, and the pre-processing cassette 50 is detachably mounted therein. The pre-processing cassette mounting section 50a may have a so-called loading mechanism, and the loading mechanism may be activated when the analyst pushes the pre-processing cassette 50 into the pre-processing unit 10, pulling it in and mounting it automatically. Alternatively, it may be a mechanism in which the analyst manually mounts it at a predetermined mounting location.

[0046] The pre-treatment cassette 50 is set with a patch 52, which is an element containing the test material, including sweat, collected from the object to be analyzed 2. Specifically, the pre-treatment cassette 50 is equipped with a holding mechanism 52a for holding the patch 52. The holding mechanism 52a is provided with a patch holder 52b (described later) for directly storing the patch 52 and a patch holder base 52c (described later) which is connected to the patch holder 52b. The pre-treatment cassette 50 is also equipped with a pre-treatment liquid tank 53 for storing the pre-treatment liquid as a fluid and a sample tank 54 for storing the liquid sample after pre-treatment.

[0047] Furthermore, a modification solution tank 56 is provided, which stores a modification solution used as a reagent for fluorescent modification during pretreatment. The number of these modification solution tanks 56 may be multiple depending on the type of modification solution. The pretreatment cassette 50 is also equipped with a pump body 51 for drawing out and pumping various reagents, and a valve body 55 for controlling which tank the reagents are drawn from and to which tank they are pumped. In addition, the pretreatment cassette 50, in combination with the pump body 51 and valve body 55, is used to add various reagents to the pretreatment solution and perform liquid testing. It is equipped with a microfluidic chip 52e that generates material.

[0048] Furthermore, the pre-treatment cassette 50 within the pre-treatment unit 10 is equipped with a valve drive unit 15 for driving the valve body 55 and a pump drive unit 13 for driving the pump body 51. In addition, a temperature control unit 14 is provided as a temperature control mechanism for maintaining the temperature of the pre-treatment liquid in the pre-treatment liquid tank 53 or the liquid sample in the sample tank 54 at an appropriate temperature.

[0049] Furthermore, the pre-treatment cassette 50 within the pre-treatment unit 10 is equipped with a mixing and stirring unit 16, which serves as a mixing and stirring mechanism for mixing and stirring the pre-treatment liquid in the pre-treatment liquid tank 53 or the liquid sample in the sample tank 54. This mixing and stirring unit 16 homogenizes the pre-treatment liquid or liquid sample and promotes the reaction by applying, for example, ultrasonic vibrations to the pre-treatment liquid in the pre-treatment liquid tank 53 or the liquid sample in the sample tank 54. This mixing and stirring unit 16 does not necessarily have to apply ultrasonic vibrations to the pre-treatment liquid in the pre-treatment liquid tank 53 or the liquid sample in the sample tank 54. For example, it may be a mechanism that mixes and stirs the pre-treatment liquid in the pre-treatment liquid tank 53 or the liquid sample in the sample tank 54 by applying at least one of light, heat, electric field, magnetic field, gravity, or inertial force.

[0050] More specifically, when applying light or heat, mixing and stirring may be achieved by generating convection in the pretreatment liquid in the pretreatment liquid tank 53 or the liquid sample in the sample tank 54. When applying an electric or magnetic field, the charge in the pretreatment liquid in the pretreatment liquid tank 53 or the liquid sample in the sample tank 54 may be moved, or a rotor made of a magnetic material may be provided in the pretreatment liquid tank 53 or the sample tank 54, and mixing and stirring may be achieved by the motion of the rotor. When applying gravity or inertial force, the pretreatment liquid tank 53 or the sample tank 54 may be physically vibrated or its orientation changed. In this disclosure, instead of the mixing and stirring unit 16, or in combination with the mixing and stirring unit 16, a mechanism for mixing and stirring the pretreatment liquid or liquid sample may be provided in the pretreatment cassette 50. For example, a structure such as a pillar array mixer that mixes and stirs the fluid may be provided in the pretreatment liquid tank 53 or the sample tank 54, or in the flow path of the pretreatment liquid or liquid sample.

[0051] Furthermore, outside the pre-processing cassette 50 within the pre-processing unit 10, there is a control board 12 that sends drive signals to the pump drive unit 13, temperature control unit 14, valve drive unit 15, and mixing and stirring unit 16, and a control unit 11 that sends command signals to the control board 12. This control unit 11 may be a computer that is connected via a network to an externally located cloud server and constitutes a cloud system. Alternatively, it may be an edge computer that constitutes an edge computing system that performs all or part of the drive mechanism, temperature control, and data processing within the device. The control unit 11 may be located inside the housing of the analyzer 1, or it may be located outside the housing.

[0052] In the pre-treatment cassette 50, the pump body 51 and valve body 55 are controlled by the pump drive unit 13 and valve drive unit 15 to supply pre-treatment liquid from the pre-treatment liquid tank 53 to the set patch 52, and the pre-treatment liquid from which sweat has been extracted is moved to the sample tank 54. In the microfluidic chip 52e, the modifying liquid from the modifying liquid tank 56 is added to the liquid sample containing sweat and mixed. By performing operations such as these, the pre-treated liquid sample is stored in the sample tank 54. Note that in Figure 6, there may be multiple pump bodies 51 and valve bodies 55.

[0053] Furthermore, the pre-treatment cassette 50 is equipped with a cleaning solution tank 99 that stores cleaning solution, and after the analysis is completed, the holding mechanism 52a, sample tank 54, pump body 51, valve body 55, etc., and at least one of the flow paths connecting them can be cleaned. In addition, a waste liquid tank is provided to store waste liquid such as pre-treatment solution and sample after analysis, and waste liquid after cleaning. It's okay if it's done that way.

[0054] Furthermore, as mentioned above, the analysis unit 20 of the analysis device 1 is equipped with an analysis cassette 60, and a portion of the liquid sample stored in the sample tank 54 of the pre-treatment cassette 50 is supplied to the sample tank 61 (described later) in the analysis cassette 60. The amount of liquid sample stored in the sample tank 54 of the pre-treatment cassette 50 is on the order of several milliliters, and the amount of liquid sample in the sample tank 61 of the analysis cassette 60 is on the order of several microliters. Therefore, in this embodiment, the sample supply unit 59 that supplies the liquid sample from the sample tank 54 to the sample tank 61 may be a mechanism that causes the liquid sample to fall by its own weight, or a mechanism that moves using capillary action. Of course, it may also be a mechanism that uses other principles. In this way, in the pre-treatment unit 10, the pre-treated liquid sample is automatically moved and stored from the sample tank 54 of the pre-treatment cassette 50 to the sample tank 61 of the analysis cassette 60.

[0055] Figures 7 to 10 are explanatory diagrams of the holding mechanism 52a in this embodiment. Figure 7 shows the patch holder 52b of the holding mechanism 52a, which is an inspection object storage section that directly stores the patch 52 after collecting sweat from the object to be inspected. Figure 7(a) is a plan view, and Figure 7(b) is a cross-sectional view. The patch holder 52b has a storage section 521b, which is a cylindrical recess for storing the patch 52, in the central part of a flange portion 520b that has a roughly disc-shaped shape. Externally, the patch holder 52b has a shape in which a cylinder formed by the outer surface of the storage section 521b is superimposed on the disc-shaped flange portion 520b. In this embodiment, the storage section 521b corresponds to the inspection object chamber.

[0056] An inlet passage 524b is provided at the bottom of the storage section 521b through which a pretreatment liquid for extracting sweat as a test sample from the patch 52 flows in. An outlet passage 525b is also provided through which the pretreatment liquid flows out after it has come into contact with the patch 52 and extracted the sweat as a test sample. Between the inlet passage 524b and the outlet passage 525b, there is a raised, levee-like protrusion 523b. The pretreatment liquid that flows into the storage section 521b from the inlet passage 524b is prevented from flowing out of the outlet passage 525b unless it comes into contact with the patch 52 by overcoming the protrusion 523b.

[0057] Furthermore, an enlarged diameter section 526b is provided at the opening of the outflow passage 525b, widening the diameter of the passage. A filter is placed in this enlarged diameter section 526b to prevent fibers detached from the patch 52 from entering the outflow passage 525b. In this embodiment, the storage section 521b is described as storing a patch 52 containing sweat, but the storage method of the inspection object or inspection object-containing element in the storage section 521b is not limited to this. For example, only the cotton part of a cotton swab used to wipe the mucous membrane inside the cheek may be stored, or hair may be stored directly or wrapped around a predetermined core. The patch holder 52b may be treated as a disposable component that is discarded after each use.

[0058] Next, Figure 8 shows a more detailed diagram of the holding mechanism 52a. The holding mechanism 52a includes two components in addition to the patch holder 52b. One is a lid 52d for sealing the patch holder 52b when it is filled with patches, etc. The lid 52d has a generally disc-like shape and is provided with a flange housing portion 520d, which is an annular recess that accommodates the flange portion 520b of the patch holder 52b, and a storage portion lid 521d that enters the storage portion 521b and closes the upper surface of the storage portion 521b. An O-ring (not shown) is fitted into the O-ring groove 522d of the lid 52d, and when the lid 52d is attached to the patch holder 52b, the O-ring is positioned between the O-ring groove 522b on the patch holder 52b side and the lid 52d, thereby sealing the space between the patch holder 52b and the lid 52d.

[0059] Furthermore, the holding mechanism 52a includes a patch holder base 52c. The patch holder base 52c has a general shape in which a smaller diameter cylinder is attached to the bottom of a larger diameter cylinder. When connected to the patch holder 52b, the patch holder base 52c has the function of supplying a pretreatment liquid to the storage section 521b and extracting and collecting sweat as a test sample from the patch. Therefore, in this embodiment, the patch holder base 52c corresponds to the extraction section. The upper part of the patch holder base 52c has a second flange storage section 520c, which is a disc-shaped recess that accommodates the lower part of the flange 520b of the patch holder 52b. It also has a storage section storage section 521c, which is a cylindrical recess that accommodates the storage section 521b.

[0060] The patch holder base 52c, when coupled with the patch holder 52b, has a second outlet passage 524c that communicates with the inlet passage 524b of the patch holder 52b. It also has a second inlet passage 525c that communicates with the outlet passage 525b of the patch holder 52b. The opening on the opposite side of the second outlet passage 524c is a pretreatment liquid inlet 523c for introducing pretreatment liquid from the pretreatment liquid tank 53. The opening on the opposite side of the second inlet passage 525c is a pretreatment liquid supply port 526c for supplying the pretreatment liquid, which contains the sweat extracted as the test material, to the microfluidic chip 52e.

[0061] In other words, by connecting the patch holder 52b and the patch holder base 52c, a flow path is completed in which the pretreatment liquid from the pretreatment liquid tank 53 is introduced through the pretreatment liquid inlet 523c of the patch holder base 52c, flows through the second outlet passage 524c and the inlet passage 524b of the patch holder 52b to the storage section 521b, comes into contact with the patch 52 to extract sweat, flows through the outlet passage 525b to the second inlet passage 525c, and is supplied from the pretreatment liquid supply port 526c to the microfluidic chip 52e that performs the next process.

[0062] Next, using Figure 9, the mechanism for adding reagents to the pretreatment liquid flowing into or out of the storage section 521b containing the patch 52 will be described. Figure 9(a) shows the mechanism for liquid reagents. Figure 9(b) shows the mechanism for powder reagents. In Figure 9(a), reagent containers 527b and 528b containing liquid reagents are provided on the lower surface of the flange portion 520b of the patch holder 52b. These reagent containers 527b and 528b are made of a flexible material and may form a ring when arranged in a semi-circular shape in a plan view, or they may have other shapes, such as being circular in a plan view.

[0063] When the patch holder 52b and the patch holder base 52c are joined, the reagent containers 527b and 528b are sandwiched between them and the patch holder base 52c, causing them to rupture and the reagents inside to leak out and be added to the pretreatment solution. Note that the reagent container configuration is not limited to just two reagent containers, 527b and 528b. Three or more reagent containers may be provided on the underside of the flange portion 520b of the patch holder 52b. Furthermore, some of the multiple reagent containers may contain water for introducing the reagents into the storage section 521b via the pretreatment solution inlet 523c.

[0064] As shown in Figure 9(b), the patch holder 52b has an enlarged diameter section 526b at the opening of the outflow passage 525b to the storage section 521b. If the reagent is in powder form, the powder reagent may be held in this enlarged diameter section 526b together with a filter. In this case, the reagent is supplied by dissolving into the pretreatment liquid as the pretreatment liquid flows in from the inflow passage 524b to the storage section 521b and outflows from the outflow passage 525b.

[0065] In this embodiment, the diameter-expanding section 526b, reagent containers 527b and 528b correspond to the reagent storage section. Furthermore, the patch holder 52b, patch holder base 52c, diameter-expanding section 526b, reagent containers 527b and 528b constitute the reagent addition section. Alternatively, in this embodiment, a space for holding powdered reagents may be provided within the storage section 521b, separate from the diameter-expanding section 526b. Good. Alternatively, a filter paper pre-soaked in a solution containing the powdered reagent and dried may be attached to the inner wall of the storage section 521b where the pretreatment liquid comes into contact. In this case, the powdered reagent dissolves from the filter paper when the pretreatment liquid comes into contact with the reagent storage section and the filter paper acting as the reagent-containing element, and is supplied to the pretreatment liquid. This makes it easier to store reagents that would otherwise require strict storage conditions in a liquid state for extended periods. Furthermore, it is possible to accurately add minute amounts of powdered reagents, which are difficult to measure and handle, to a fluid. In this embodiment, the powdered reagent may also be held throughout the entire storage section 521b. If the powdered reagent is held throughout the entire storage section 521b, the patch holder 52b itself may be stored in a sealed container to prevent the powdered sample from detaching from the storage section 521b.

[0066] Next, the function of the ultrasonic generator 529c provided in the patch holder base 52c will be explained using Figure 10. The ultrasonic generator 529c is located below the storage compartment 521c of the patch holder base 52c. This ultrasonic generator 529c is embedded in the bottom of the storage compartment 521c. Ultrasound is then applied to the patch 52 in the storage compartment 521b, which is housed in the storage compartment 521c. By applying ultrasound to the patch 52, the sweat contained in the patch 52, which is the material to be examined, is more reliably extracted into the pretreatment solution.

[0067] As shown in Figure 10, the pre-processing cassette 50 may also be used as an extended function to perform pre-processing of the sample using a cell counting microfluidic chip 52f provided inside. In Figure 10, as an example, it has the function of counting the number, density, mass, etc. of cells contained in a liquid sample. In this case, an optical observation area 520f is provided in the cell counting microfluidic chip 52f, with the channel cross-section of the second inflow passage 525c flattened, and cells passing through the optical observation area 520f are optically observed with a digital microscope 52g and the cells are counted.

[0068] Therefore, the ultrasonic generator 529c applies ultrasonic waves of an intensity that does not destroy cells to the storage section 521b in the patch holder 52b. On the other hand, for liquid samples after pre-treatment for cell counting is complete, the second inflow passage 525c downstream of the cell counting microfluidic chip 52f passes near the ultrasonic generator 529c compared to the bottom surface of the storage section 521b. As a result, stronger ultrasonic waves from the ultrasonic generator 529c act on the second inflow passage 525c downstream of the cell counting microfluidic chip 52f.

[0069] This makes it possible to destroy cells in this region. In this embodiment, the distance between the ultrasonic generator 529c and the target of the ultrasonic waves is adjusted. This makes it possible to apply relatively weak ultrasonic waves to the patch 52 in the storage unit 521b and relatively strong ultrasonic waves to the liquid sample passing through the second inflow passage 525c downstream of the cell counting microfluidic chip 52f. Complex control, such as changing the output of the ultrasonic generator 529c depending on the target of the ultrasonic waves, is not required.

[0070] Figure 11 is an explanatory diagram of another embodiment of the holding mechanism 52a in this embodiment. The patch holder 52h has a shape in which a cylinder formed by the outer surface of the storage section 521h is superimposed on a disc-shaped flange portion 520h. An inlet passage 524h into which the pretreatment liquid flows is opened at the bottom surface of the storage section 521h. An outlet passage 525h into which the pretreatment liquid flows out after the sweat as the test material has been extracted is also opened. In addition to the patch holder 52h and the lid portion 52j, the holding mechanism 52a in this embodiment also includes a patch holder base 52i. The patch holder base 52i has a roughly cylindrical shape. At the top of the patch holder base 52i, there is a storage section housing portion 521i, which is a cylindrical recess that accommodates the outer wall of the storage section 521h of the patch holder 52h.

[0071] The patch holder base 52i, when coupled with the patch holder 52h, has a second outlet passage 524i that communicates with the inlet passage 524h of the patch holder 52h. It also has a second inlet passage 525i that communicates with the outlet passage 525h of the patch holder 52h. The opening on the opposite side of the second outlet passage 524i is a pretreatment liquid inlet 523i for introducing pretreatment liquid from the pretreatment liquid tank 53. The opening on the opposite side of the second inlet passage 525i is connected to a pretreatment liquid supply port 526i for supplying pretreatment liquid, which contains the sweat extracted as the test material, to the microfluidic chip 52e.

[0072] When the patch holder 52h and the patch holder base 52i are connected, the pretreatment liquid from the pretreatment liquid tank 53 is introduced through the pretreatment liquid inlet 523i of the patch holder base 52i, flows through the second outlet passage 524i and the inlet passage 524h of the patch holder 52h to the storage section 521h, comes into contact with the patch 52 to extract sweat, flows through the outlet passage 525h to the second inlet passage 525i, and is supplied from the pretreatment liquid supply port 526i to the microfluidic chip 52e that performs the next process. These configurations are the same as the holding mechanism 52a shown in Figure 8.

[0073] Next, the differences between this embodiment and the hold mechanism 52a shown in Figure 8 will be explained. First, in this embodiment, there is no protruding section between the inflow passage 524h and the outflow passage 525h on the bottom surface of the storage section 521h. Also, the height of the storage section 521h is lower compared to the hold mechanism 52a shown in Figure 8. In the hold mechanism 52a shown in Figure 8, the pre-treatment liquid that flows into the storage section 521b from the inflow passage 524b is prevented from flowing out of the outflow passage 525b unless it comes into contact with the patch 52 by overcoming the protruding section 523b. In addition, the patch 52 is sandwiched between the storage section lid 521d and the protruding section, so that the sweat absorbed by the patch 52 is extracted into the storage section 521b. The height of the storage section 521b, that is, the distance from the bottom surface of the storage section 521b to the storage section lid 521d when the lid 52d is attached to the patch holder 52b, was assumed to be about 2 to 3 mm.

[0074] In contrast, in this embodiment, the height of the storage section 521h is sufficiently low, about 1 mm, and even without the protruding portion 523b, the patch 52 is sandwiched between the bottom surface of the storage section 521h and the storage section lid 521j, and the sweat absorbed by the patch 52 is extracted into the storage section 521h. This makes it possible to extract sweat as a test material with less pretreatment liquid, and to increase the concentration of amino acids as specific components.

[0075] Furthermore, in this embodiment, the pretreatment liquid supply port 526i is formed perpendicular to the plane of the paper in Figure 11, and the pretreatment liquid flows from the front to the back of the paper. Also, in this embodiment, the upper surface of the ultrasonic generator 529i is attached to the horn 528i that conducts ultrasonic waves, and the lower surface is free. This makes it possible to conduct ultrasonic waves to the horn 528i more smoothly. In addition, as shown in Figure 11, the horn 528i has a U-shaped groove at its upper end, and the horn 528i is fixed to the patch holder base 52i such that this U-shaped groove tightly surrounds the pretreatment liquid supply port 526i. With this structure, powerful ultrasonic waves can be applied to the pretreatment liquid passing through the pretreatment liquid supply port 526i more efficiently, and the sweat as the test material and the pretreatment liquid can be mixed and stirred more reliably. Furthermore, by generating microbubbles, it is possible to further reliably stir the mixture of sweat as the test material and the pretreatment liquid.

[0076] Figure 12 shows a detailed diagram of the main microfluidic chip 52e provided in the pretreatment cassette 50. The microfluidic chip 52e is connected to a second inflow passage 525c, and the pretreatment liquid from which sweat has been extracted flows in through the upper right port in the diagram of the microfluidic chip 52e and flows out through the lower left port. Reagents are then introduced into the liquid sample passing through the second inflow passage 525c from ports 521e, 522e, and 523e, respectively, and each is mixed through a meandering mixing channel. Mixing takes place in the mixing passage 524e. Then, in the optical observation area 520e, the state of the liquid sample is optically observed or measured. In addition, a heater is provided in the region 525e in the microfluidic chip 52e where the reaction between the liquid sample and the pretreatment solution occurs, and the temperature of the liquid sample and reagents is controlled.

[0077] Next, Figure 13 shows the specific structure of the analysis unit 20 in this embodiment. The analysis unit 20 is provided with an analysis cassette mounting section 60b to which an analysis cassette 60 can be attached, and the analysis cassette 60 is detachably mounted. The analysis cassette mounting section 60b may have a so-called loading mechanism, and the loading mechanism may be activated when the analyst pushes the analysis cassette 60 into the analysis unit 20, pulling it in and automatically mounting it. Alternatively, it may be a mechanism in which the analyst manually mounts it at a predetermined mounting location. As mentioned above, the analysis cassette 60 is provided with a sample tank 61 in which the pre-treated liquid sample is stored. It is also provided with a second pump body 62 for moving the liquid sample in the sample tank 61, and a second valve body 66 as a second valve body.

[0078] Furthermore, a mobile phase tank 63 is provided in which the mobile phase is stored. A first pump body 64 and a third pump body 65, and a first valve body 67 are provided for moving the mobile phase in the mobile phase tank 63. An analysis tip 68 is provided as a measuring unit, and a waste liquid tank 69 is provided as a waste tank for storing the waste liquid after it has passed through the analysis tip 68. Here, the first pump body 64 is used for a hydrophilic mobile phase, and the third pump body 65 is used for a lipophilic mobile phase.

[0079] The analysis cassette 60 contains a second valve drive unit 26 for driving the second valve body 66 and a second pump drive unit 23 for driving the second pump body 62. It also contains a first valve drive unit 27 for driving the first valve body 67, and a first pump drive unit 24 and a third pump drive unit 25 for driving the first pump body 64 and the third pump body 65, respectively. Furthermore, it contains a detection optical system 28 for detecting amino acids by irradiating a liquid sample moving within the analysis tip 68 with detection light and receiving the output light.

[0080] Furthermore, outside the analysis cassette 60 within the analysis unit 20, there is a control board 22 that sends drive signals to the second pump drive unit 23, the second valve drive unit 26, the first pump drive unit 24, the third pump drive unit 25, and the first valve drive unit 27, and a control unit 21 that transmits command signals to the control board 22.

[0081] Furthermore, in the analysis unit 20, amino acid analysis is performed by irradiating the liquid sample moving within the analysis chip 68 with inspection light from the detection optical system 28 and detecting the emitted fluorescence. The analysis results data may be stored in the memory of the control unit 21. In addition, the analysis unit 20 is equipped with a waste liquid tank 69 inside the analysis cassette 60 for storing waste liquid after analysis. Therefore, there is no need to dispose of the chemical solution outside the analysis unit 20, which increases the flexibility of the installation location of the analysis unit 20.

[0082] Figure 14 shows a schematic configuration of the pillar array column 70 used in the analysis tip 68 in this embodiment. Figure 14(a) is a plan view of the pillar array column 70, and Figure 14(b) is an enlarged view of the internal structure of the separation channel 72, which serves as the analysis channel of the pillar array column 70. Figure 14(c) shows an enlarged view of the curved structure of the separation channel 72 of the pillar array column 70. The pillar array column 70 is made using a silicon substrate, and the separation channel 72 is fabricated by photolithography and dry etching.

[0083] In the pillar array column 70, the mobile phase flows in from the first inlet 71. A liquid sample flows in through the inlet 76. At the point where the sample injection channel 77, which serves as a sample flow path, and the separation channel 72 intersect, the liquid sample flows into the separation channel 72 by being carried along with the flow of the mobile phase. Fine pillar structures (columnar structures) 72a, as shown in Figure 14(b), are formed in the separation channel 72. The liquid sample is separated as the mobile phase and the liquid sample move through the gaps in these pillar structures 72a. The pillar structures may be square or rhombic columns with sides of several micrometers. The gap width in the pillar structures may be set to a width smaller than the length of one side of the column (pillar).

[0084] In the pillar array column 70, to ensure higher separation efficiency, the separation channel 72 is made longer by forming a folded curved channel. In this curved structure 73, as shown in Figure 14(c), the length of the outer and inner circumferences of the channel are made equal, thereby suppressing the generation of turbulence within the separation channel 72 and inhibiting the diffusion of the separated liquid sample. Furthermore, measures have been taken such as making the density of the pillars higher on the inner side compared to the outer side.

[0085] With the pillar array column 70, analysis of liquid samples is possible with mobile phase and liquid sample flow rates of several μl / min. Thus, by using the pillar array column 70, analysis is possible at lower flow rates compared to analysis with conventional columns, and the amount of mobile phase and liquid sample can be reduced, allowing for miniaturization of the pre-processing unit 10 and the analysis unit 20.

[0086] Figure 15 shows an example of the schematic configuration of the detection optical system 28 in this embodiment. In the detection optical system 28, an LD28a with a fluorescence excitation wavelength of a fluorescence-modified amino acid is used as the light source. The detection light emitted from the LD28a passes through the beam splitter 28b, its direction is changed by the mirror 28c, as shown by the solid line in Figure 15, and then it is focused by the objective lens 28d and irradiated onto the separation channel 72 in the analysis chip 68. In this case, the analysis cassette 60 may be made entirely of a transparent material such as glass, or it may be made entirely of metal with a transparent window provided near the incident part of the inspection light.

[0087] Furthermore, the analysis tip 68 may be made of glass on the side facing the detection optical system 28 and of a metal such as SUS on the opposite side. When the separated liquid sample passes through, as shown by the dashed line, the fluorescence from the liquid sample passes through the objective lens 28d, is reflected by the mirror 28c, and then reflected by the beam splitter 28b. After that, only the fluorescence component is selected by the filter 28e, which allows light of the fluorescence wavelength to pass through, and is detected by the photodetector 28f.

[0088] Thus, the analysis unit 20 of this embodiment can employ a detection optical system having a configuration similar to that of the recording and playback optical system used in optical recording devices such as DVDs. This makes it possible to miniaturize the analysis unit 20.

[0089] In the analysis apparatus 1 described above, a pre-treatment cassette 50 is installed in the pre-treatment unit 10. Pre-treatment is performed within the pre-treatment unit 10 to generate a liquid sample. An analysis cassette 60, to which the liquid sample is supplied, is installed in the analysis unit 20, and the liquid sample is analyzed within the analysis unit 20. Waste liquid is also stored in the analysis cassette 60. Therefore, there is no need to connect the pre-treatment unit 10 and the analysis unit 20 to the outside with piping, and there is no exchange of chemicals. Thus, it is possible to easily analyze biological components regardless of location. Furthermore, the inconvenience of liquid sample accumulating in the dead volume of piping connections, which reduces analytical accuracy, is also eliminated.

[0090] In this embodiment, it is possible to select an appropriate pre-treatment cassette 50 and analysis cassette 60 depending on the type of sample and the analytical principle. In other words, by appropriately combining the pre-treatment cassette 50 and analysis cassette 60, it becomes possible to analyze various samples.

[0091] Next, we will describe an example in which the analysis cassette 60 is equipped with an enzyme reaction chip 68a, which includes a paper device 680a for measuring enzyme reactions, as shown in Figure 16, as the measurement unit, instead of an analysis chip 68. The paper device 680a is made by cutting filter paper or by screen printing on a porous ceramic material. The paper device 680a is fixed to a base such as a resin plate, and the overall strength is provided by a frame 681a. The enzyme reaction chip 68a is replaced and discarded after each analysis. The enzyme reaction chip 68a shown in Figure 16(a) is a chip capable of detecting whether or not four types of amino acids are present in a liquid sample after pretreatment.

[0092] In the enzyme reaction chip 68a shown in Figure 16(a), the four enzyme reaction sections 684a contain enzymes that react with specific amino acids to produce specific colors, and these enzymes are then dried. When a liquid sample is dropped onto the central sample dropper section 682a, the liquid sample moves along the filter paper, soaking in and reacting with each enzyme as it passes through the enzyme reaction sections 684a. Finally, the liquid sample reaches the color-developing sections 685a, and each of the four color-developing sections 685a develops a color corresponding to a specific amino acid and enzyme combination. Therefore, in the case of Figure 16(a), it is possible to detect the types of multiple amino acids contained in the liquid sample by detecting the colors of the four color-developing sections 685a. In the enzyme reaction chip 68a, the temperature of the enzyme reaction section 684a is controlled by a heater device 686a to stabilize the reaction between the liquid sample and each enzyme in the enzyme reaction section 684a.

[0093] Figure 16(b) shows an enzyme reaction chip 68b that can contain 12 types of enzymes in the enzyme reaction section 684b beforehand and is dried, and can detect 12 types of amino acids. The enzyme reaction chip 68b, which serves as the measurement section, has a paper device 680b fixed to a base such as a resin plate, and an annular frame 681b provides overall strength. In this case as well, when a liquid sample is dropped onto the central sample dropping section 682b, the liquid sample moves along the filter paper as it soaks in, and as it passes through the enzyme reaction section 684b, it reacts with each enzyme as a measurement reagent, causing the 12 color development sections 685b to develop colors corresponding to specific amino acid and enzyme combinations. In addition, in the enzyme reaction chip 68b, the temperature of the enzyme reaction section 684b is controlled by a heater device 686b to stabilize the reaction between the liquid sample and each enzyme in the enzyme reaction section 684b. In this embodiment, the colors of all color-producing areas may be captured simultaneously by an imaging unit using a wide-angle lens, such as a fisheye lens, and the color pattern in a single image may be analyzed to identify the types of amino acids contained in the liquid sample.

[0094] Next, Figure 17 shows an enzyme reaction chip 68c, which is another embodiment of the enzyme reaction chip as a measurement unit or measurement chip. The enzyme reaction chip 68c has a structure in which a color-developing unit 680c, which is made of a paper device such as filter paper, is attached in a circular pattern to a base such as resin. Then, a measurement reagent that reacts directly with a liquid sample to produce color, without requiring the enzyme reaction unit 684b, is combined with the color-developing unit 680c and pre-soaked in it and dried, and then the liquid sample is dropped directly onto the color-developing unit 680c to detect the change in color.

[0095] In the example shown in Figure 17, it is possible to detect 12 types of amino acids using 12 types of reagents. In this embodiment, the enzyme reaction chip 68c is rotated while the liquid sample is sequentially dropped onto each color-developing section 680c. The color at each color-developing section 680c may be photographed and determined sequentially, or the color changes at all color-developing sections 680c may be photographed simultaneously with an imaging unit having a wide-angle lens such as a fisheye lens, and the types of amino acids contained in the liquid sample may be determined by image processing.

[0096] In this embodiment, an annular water-repellent portion 681c having a water-repellent function may be provided around the color-developing portion 680c. This water-repellent portion 681c is made of a water-repellent material. It may be present, or it may be made water-repellent by forming minute protrusions on the surface shape. This water-repellent portion 681c prevents the liquid sample from spreading unintentionally when dropped onto the color-developing portion 680c, thus preventing a decrease in the amount of specific components in the liquid sample absorbed by the color-developing portion 680c. Furthermore, by evaporating the solvent during the time the liquid sample is held on the water-repellent portion 681c, it is possible to increase the concentration of specific components in the liquid sample.

[0097] In addition, with the analysis cassette 60, when measuring the amount of NAD / NADH in cells, the reagents and liquid sample may be mixed, and the fluorescence, fermentation, or absorbance of the mixture may be detected in the measurement unit. The amino acids in the liquid sample may then be detected by comparing the changes in specific wavelength intensity with a calibration curve. In this case as well, the detection optical system 28 shown in Figure 15 can be used with some modifications as necessary.

[0098] Next, the liquid sample concentration function in the sample supply unit 59 in this embodiment will be explained using Figures 18-20. Figure 18 shows the mechanism for supplying the pre-treated liquid sample generated in the pre-treatment cassette 50 to the analysis cassette 60 using its own gravity. As shown in the upper part of Figure 18, the liquid sample generated in the pre-treatment cassette 50 gradually descends from the nozzle 59a in the sample supply unit 59. A droplet grows at the tip of the nozzle 59a, and when the droplet becomes sufficiently large, it falls due to its own gravity and is received by the receiving part 59b provided on the analysis cassette 60 side.

[0099] Here, as the droplet grows at the tip of the nozzle 59a, the solvent evaporates from the droplet. Therefore, by the time the droplet falls from the tip of the nozzle 59a, it is possible to concentrate specific components in the liquid sample and increase their concentration. In this embodiment, the evaporation of the solvent can be accelerated by heating the nozzle 59a, thereby efficiently concentrating the liquid. Alternatively, the rate of droplet growth can be controlled by pressurizing the liquid reagent with a pump or the like.

[0100] Figure 19 shows a sample supply unit 159 as an alternative example. In the sample supply unit 159, a predetermined voltage V is applied to the nozzle 159a. Meanwhile, the receiving unit 159b is grounded. As a result, the droplet becomes charged, and an electric field is generated between the nozzle 159a and the receiving unit 159b. The charged droplet is attracted to the receiving unit 159b by the electric field. With this configuration, in addition to its own weight, an electromagnetic force acts on the droplet growing at the tip of the nozzle 159a, so relatively small droplets move from the tip of the nozzle 159a to the receiving unit 159b. Since droplets with small volume have a relatively large surface area relative to their volume, they can efficiently evaporate the solvent, making it possible to concentrate specific components more reliably compared to the case of free fall alone.

[0101] Figure 20 shows a sample supply unit 259 in which the tip shape of the nozzle 259a is further divided into multiple branches, with each individual nozzle tip being tapered. In this case, as with the example shown in Figure 19, the droplets growing at the tip of the nozzle 259a are subjected to an attractive force due to the electric field in addition to their own weight. Furthermore, because the tip of the nozzle 259a is tapered, the droplets move away from the nozzle 259a and to the receiving unit 259b in a smaller state. At that time, very fine droplets move, so it is possible to evaporate the solvent more efficiently and concentrate specific components in the liquid sample received in the receiving unit 259b, thereby increasing the concentration.

[0102] In the above embodiment, the configuration of the pre-processing unit 10, specifically which components are placed in the pre-processing cassette 50 and made interchangeable, and the configuration of the analysis unit 20, specifically which components are placed in the analysis cassette 60 and made interchangeable, are merely examples. The distribution of these components to the pre-processing cassette 50 and analysis cassette 60 can be appropriately determined according to the analysis target, analysis principle, and scale of the analysis apparatus 1. [Explanation of Symbols]

[0103] 1...Analyzer 10. Pre-treatment section 20...Analysis Department 50 Pre-processing Cassettes 52a...Holding mechanism 52e... Microfluidic Chip 59.. Sample Supply Department 60...Analysis Cassettes 68a... Enzyme reaction chip

Claims

1. An analytical device for analyzing specific components in a sample taken from an object to be analyzed, An inspection object storage unit for storing the inspection object or an inspection object containing the inspection object, An extraction unit is connected to the inspection object storage unit and extracts the specific component from the inspection object or the inspection object-containing element stored in the inspection object storage unit into a fluid to obtain a fluid sample, A reagent storage section for storing liquid or powdered reagents, During the extraction of the specific component into the fluid by the extraction unit, the reagent addition unit adds the reagent to the fluid, An analytical apparatus characterized by being equipped with the following features.

2. The reagent is a liquid reagent, and the reagent storage unit is a container provided in the test sample storage unit that stores the liquid reagent. The analytical apparatus according to claim 1, characterized in that when the sample storage unit and the extraction unit are joined, the container breaks, thereby adding the reagent to the fluid.

3. The reagent is a powdered reagent, and the reagent storage section is a part provided in the test material storage section for storing the powdered reagent. The analytical apparatus according to claim 1, characterized in that, when the extraction unit extracts the specific component into the fluid, the fluid flows into the inspection object storage unit so as to come into contact with the inspection object or the inspection object containing element in the inspection object storage unit, and also comes into contact with the powdered reagent in the reagent storage unit, thereby adding the reagent to the fluid.

4. The analytical apparatus according to claim 3, characterized in that the inspection material storage section is sealed before use, and the sealed state is released by opening the section when the specific component is extracted into the fluid by the extraction section.

5. The analytical apparatus according to claim 3, characterized in that the reagent storage unit is provided in the test material storage unit and is a reagent-containing element that contains a solution containing the powdered reagent and is dried.

6. The extraction unit is provided with an ultrasonic generator that generates ultrasonic waves. The analytical apparatus according to claim 1, characterized in that, when the extraction unit extracts the specific component into the fluid, the ultrasonic generator applies ultrasonic waves to the object to be inspected or the object containing the object to be inspected in the object storage unit.

7. The analytical apparatus according to claim 6, characterized in that the ultrasonic generator applies ultrasound to the fluid sample from which the specific component has been extracted by the extraction unit and to which the reagent has been added by the reagent addition unit.

8. The inspection object storage unit comprises an inspection object chamber in which the inspection object or the inspection object-containing element is stored, an inflow passage for introducing the fluid into the inspection object chamber, and an outflow passage for introducing the fluid out of the inspection object chamber. The extraction unit is provided with a second outflow passage through which the fluid flows out before the extraction of the specific component, and a second inflow passage through which the fluid flows in after the extraction of the specific component. The analytical apparatus according to claim 1, characterized in that when the material storage section and the extraction section are connected, the inflow passage and the second outflow passage are in communication, and the outflow passage and the second inflow passage are in communication, thereby allowing the fluid before the extraction of the specific component to flow into the material chamber.

9. An analytical device for analyzing specific components in a sample, A preprocessing unit that performs preprocessing on the sample taken from the object to be analyzed to enable the detection of the specific component, The system includes an analysis unit that performs analysis of the specific components in the sample that has undergone the aforementioned pretreatment, The aforementioned pre-processing unit, An inspection object storage unit for storing the inspection object or an inspection object containing the inspection object, An extraction unit extracts the specific component from the object or element containing the object stored in the object storage unit into a fluid to obtain a fluid sample, A reagent storage section for storing liquid or powdered reagents, A reagent addition unit for adding the reagent to the fluid, It has a pre-processing cassette mounting section for mounting a replaceable pre-processing cassette, At least a portion of the functions of the sample storage unit, the extraction unit, the reagent storage unit, and the reagent addition unit are housed in the pre-processing cassette mounted in the pre-processing cassette mounting unit. The aforementioned analysis unit is A measuring unit for detecting or measuring the specific component in the fluid sample from which the specific component has been extracted and to which the reagent has been added, It has an analysis cassette mounting section into which an analysis cassette is attached, which is replaceable and detects and analyzes the specific components contained in the fluid sample. At least a part of the functions of the measurement unit are housed in the analysis cassette mounted on the analysis cassette mounting unit. An analytical apparatus further comprising a sample supply unit for supplying the fluid sample that has been pre-treated in the pre-treatment unit to the analysis unit.

10. In the analytical apparatus, the preprocessing unit is located above the analytical unit. The aforementioned sample supply unit is The pre-treated fluid sample in the aforementioned pre-processing unit is dropped by a nozzle under its own weight, A receiving unit that receives the dropped fluid sample and supplies it to the analysis unit, The analytical apparatus according to claim 9, characterized by having the following features.

11. The analytical apparatus according to claim 10, characterized in that a predetermined potential difference is provided between the nozzle in the sample supply unit and the receiving unit.

12. The analytical apparatus according to claim 11, characterized in that the tip of the nozzle is divided into a thinner tip nozzle.

13. An analytical device for analyzing specific components in a sample, A preprocessing unit that performs preprocessing on the sample taken from the object to be analyzed to enable the detection of the specific component, The system includes an analysis unit that performs analysis of the specific components in the sample that has undergone the aforementioned pretreatment, The aforementioned pre-processing unit, The unit has an extraction section that extracts the specific component from the inspected object or an inspected object-containing element containing the inspected object into a fluid to obtain a fluid sample. The aforementioned analysis unit is The measuring chip contains a measuring reagent that reacts with the aforementioned specific component to produce a specific color, In the aforementioned measurement chip, multiple types of measurement reagents, each reacting with multiple types of the aforementioned specific components, are contained in different locations. An analytical apparatus further comprising an imaging unit capable of simultaneously capturing colors at different locations.

Images