JP6638162B2 - Inspection system and inspection method - Google Patents

Description

  The present invention relates to an inspection system, an inspection method, and an inspection substrate that can be used in a clinical site immediate inspection, that is, a so-called point of care test (POCT).

  Allergic diseases include hay fever, atopic dermatitis, bronchial asthma, food allergy, drug allergy, and various allergic diseases are known. In recent years, it has been said that 42 million people have some relationship with allergies out of 120 million people, and the number is increasing. It is said that the reason for the increase in the number of allergic disease patients is the increase in sensitizing substances (antigens) in the daily living environment and the high exposure to sensitizing substances. Since allergic diseases cannot be separated from the daily living environment, in treatment, it is not enough to just suppress the symptoms with a drug and inevitably recur. Therefore, it is important to treat the cause by identifying the causative substance. Therefore, in allergy departments, dermatology, internal medicine, and the like in hospitals and clinics, diagnosis for identifying an antigen that is a causative substance causing an allergic symptom, ie, an allergen, is indispensable in medical care related to an allergic disease. However, there are many types of allergens, such as 200 or more. Therefore, in order to identify allergens therein, it is indispensable to test allergen species in multiple items.

  Here, the mechanism of allergy development will be briefly described. An allergic symptom is an antigen-antibody reaction in which an antigen acts on a body (living body) to perform an immune function. As a result of this reaction, immunoglobulin (abbreviated as Ig) is produced. An immunoglobulin is a protein and the structure is a chain of amino acids. Currently, five types of immunoglobulins, A, G, D, M, and E, are known. Among them, it is known that an excessive reaction of E type immunoglobulin E (abbreviated to IgE) causes allergic symptoms. Have been. That is, when IgE is produced, so-called sensitization, in which IgE binds to mast cells in blood, is established. When the antigen further enters after the sensitization is established, IgE bound to the mast cell binds to the antigen, and a chemical transfer substance such as histamine is released from the mast cell, thereby causing allergic symptoms. Since antibodies recognize and react with molecules, different IgEs (abbreviated as specific IgEs) are produced for each allergen species, and the sensitization state differs for each allergen (Non-Patent Document 1, Non-Patent Document 1). Patent Document 2).

  One method for identifying allergens is a skin provocation test in which the allergen is added directly to the skin. In a prick test as an example of a skin provocation test, an allergen is dripped on the skin surface and a wound is made on the skin surface with a needle to absorb the allergen into the body. And this confirms the reaction to the allergen. Such a skin provocation test is highly accurate in that the response to an allergen can be directly confirmed. However, there is a risk of anaphylactic shock and the like, which may put the patient at risk (Non-Patent Document 3). Therefore, in recent years, a test tube test for collecting a patient's blood and measuring the amount of IgE in serum has become widespread and widely used because of the low burden on the patient and the simplicity of the test.

  In a test tube for measuring the amount of IgE, the sensitizing allergen is specified by measuring the concentration of allergen species-specific IgE in the blood. The specific allergen concentration is very small. If the concentration is 1.68 [ng / mL] or more, it is positive (Class 2). If it is 0.84 [ng / mL] or more, it is false positive (Class 1). ) Is determined. It is standard to classify into 7 stages up to strong positive (class 6) of 240 [ng / mL] or more.

  There are various methods for detecting the amount of IgE, such as the CAP method and the MAST method. The basic measurement principle of these allergen-specific IgE calibration methods is the same. That is, the target sample is caused to act on the surface of the carrier on which the allergen is immobilized, and IgE of the sample reacts with the allergen. Thereafter, IgE derived from the specimen that has reacted and bound to the allergen is reacted with an anti-IgE antibody capable of binding to the IgE antibody, and the anti-IgE antibody is detected. As a result, the IgE amount can be measured. The anti-IgE antibody is labeled, and a fluorescent molecule, a chemiluminescent molecule, a chemical coloring molecule, or a radioisotope is used for the label.

  The CAP method commercialized by Phadia is currently the most widespread allergen-specific IgE calibration method in the world. In this method, one well is used as a carrier of one type of allergen, and one sample is added to the well to determine the presence or absence of an IgE antibody against the allergen immobilized in the well. In other words, the CAP method is a single item method. Therefore, in the CAP method, only one type of allergen can be determined per well. Therefore, in a screening analysis for specifying an allergen, it is necessary to separately use multiple types of wells. At this time, a serum sample sample of 40 microliters is required for each well, and a large amount of a blood sample is likely to be required. Therefore, for example, in the case of measuring a maximum of 13 items that can be performed with a normal insurance score, a serum sample of 520 microliters is required. For this reason, about 1 milliliter of a blood sample is required, which is a barrier to the application to baby and infant tests.

  On the other hand, the MAST method is a technical method developed for the purpose of improving the analysis efficiency. The MAST method is an abbreviation of Multiple Antigen Simultaneous Test and means a simultaneous multi-item allergen-specific IgE antibody measurement method. Patent Document 1 describes a configuration related to the MAST method. In the method of Patent Literature 1, a plurality of carriers having different allergens are arranged in a long support container, and a sample is allowed to act on the entire inside of the container. After that, individual carrier signal intensities are analyzed, and the amount of IgE antibody against each allergen is analyzed. With this method, simultaneous analysis of up to 33 antigens is now possible, and the serum sample is as small as 200 microliters.

By the way, in clinical practice, opportunities to apply the clinical practice immediate inspection, so-called POCT (Point Of Care Testing) are increasing. The POCT has the advantage that a medical worker performs an examination beside the subject, or the subject performs the examination itself, and the examination result is obtained on the spot. Therefore, POCT is expected to provide faster and more appropriate medical care and nursing compared to the case of requesting an external laboratory to perform tests, and to improve the quality of medical care and the quality of life (QOL) of patients. (Non-Patent Document 4).
POCT is also expected for allergy diagnosis. However, the CAP method described above has a problem that the analyzer is large. That is, the analyzer is installed in a specialized laboratory, and a clinical site usually requests an external laboratory to perform the test. Further, in the MAST method described in Patent Document 1, the time required for measurement is 6 hours, and there is a problem that the measurement time is too long. Therefore, the CAP method and the MAST method are unsuitable as the methods used for POCT.

As configurations that can be used in POCT, configurations described in Patent Literatures 2 to 4 and Non-Patent Literature 5 are conventionally known.
Patent Literature 2 describes a configuration relating to an immunochromatography method in which a multi-item inspection and an on-site inspection are compatible. The immunochromatography method uses a thin layer chromatography method often used in POCT. In the immunochromatography method, a well is not used, and a thin layer in which a sample liquid of a specimen is automatically developed by capillary action is used. In the thin layer, the allergen is linearly solid-phased in the middle of the direction in which the sample solution is developed. Therefore, when the sample solution develops a thin layer, the antibody in the sample solution can react with the allergen. In the immunochromatography method, if a step of injecting a sample solution and a color developing solution is performed, the inspection can be performed.

  As another configuration in which the processing steps are automated, Patent Document 3 discloses an automatic biochip analysis system (1). In Patent Document 3, a well-shaped biochip (2) is used. Twenty or more types of allergens are optically fixed on the biochip (2) as spots (2d). In Patent Literature 3, first, a biochip (2) is installed in an installation station (8), and blood serum as a specimen is discharged into the biochip (2) using a manual pipette or the like. Then, the biochip (2) from which the sample has been discharged is automatically conveyed from the installation station (8) to the nozzle station (9) by the belt conveyor (14). When the biochip (2) reaches the nozzle station (9), the nozzles (9a to 9d) for the washing solution, the antibody reagent, the luminescent reagent, and the suction are integrally lowered from above, and the nozzles (9a to 9d) are lowered. The tip of 9d) is placed inside the biochip (2).

  At this time, first, the suction nozzle (9d) operates to suck out the sample liquid in the biochip (2). Thereafter, the cleaning liquid in the cleaning liquid tank (21) is discharged from the cleaning liquid nozzle (9a) to clean the inside of the biochip (2). The cleaning liquid after the cleaning is sucked out by the suction nozzle (9d). Then, a labeled antibody, that is, an antibody reagent, is injected into the biochip (2). The antibody reagent reacts only with the spot (2d) that has reacted with the sample. When a predetermined reaction time has elapsed, the remaining antibody reagent is sucked out, and the inside of the biochip (2) is washed again. When the washing of the antibody reagent is completed, the luminescent reagent is injected into the biochip (2). The luminescent reagent reacts only with the spot (2d) that has reacted with the antibody reagent, causing the spot (2d) to emit light. When the step of reagent injection is completed, the nozzles (9a to 9d) are raised to their original positions, the belt conveyor (14) is operated, and the biochip (2) is moved from the nozzle station (9) to the CCD camera station (9). It is carried to 10). In the CCD camera station (10), the light emission state of the spot (2d) in the biochip (2) is imaged by the CCD camera (10c), and it becomes possible to specify various items of allergens based on the light emission intensity.

  Patent Literature 4 describes a biochemical reaction chip (10) that can be used in an automated processing step, a method of drainage treatment, and the like. The biochemical reaction chip (10) of Patent Document 4 has a square substrate (1). A cylindrical wall (2) is supported on the substrate (1). On the substrate (1), a hydrophobic ring (4) which is hydrophobically coated concentrically with the cylindrical wall (2) is provided inside the cylindrical wall (2). A number of allergens are fixed as spots inside the hydrophobic ring (4). In Patent Document 4, when the cleaning liquid or the like is injected, the inside of the cylindrical wall portion (2) is filled with the liquid, and the entire upper surface of the substrate (1) is filled with the liquid. At the time of drainage, the nozzle (31) is relatively moved inside the hydrophobic ring (4), and suction is performed so that the entire surface of the substrate (1) is covered with the liquid. Thereafter, the nozzle (31) is relatively moved between the hydrophobic ring (4) and the cylindrical wall (2) to perform the second suction. Thus, in Patent Document 4, the liquid is discharged from the biochemical reaction chip (10) by utilizing the cohesive force of the liquid. Patent Document 4 describes that the tip for biochemical reaction (10) is inclined or the tip for biochemical reaction (10) is blown to assist drainage.

Japanese Patent Application Laid-Open No. 60-89553 (page 3, upper left column, first line to page 6, upper right column, line 12, FIG. 1 to FIG. 5) JP 2002-286716 A (“0013” to “0040”, FIG. 1) JP 2011-13000 A (“0034” to “0041”, FIG. 3) JP 2013-24605 A (“0028” to “0035”, “0056” to “0065”, FIG. 1)

“Mechanism of Allergy”, [online], [searched on December 26, 2013], Internet <URL: http://www.zaditen-al.jp/pharmacist/mechanism.html> Masato Kubo, [online], [searched on December 26, 2013], Internet <URL: http://www.rcai.riken.jp/group/IgE/> Dermatology, "prick test", [online], [searched on December 26, 2013], Internet <URL: http://kompas.hosp.keio.ac.jp/contents/000358.html> Shoji Matsuo, “Current Status and Issues of POCT”, [online], [Searched on December 26, 2013], Internet <URL: http://plaza.umin.ac.jp/naraamt/mahoroba_vol20/P9%20wadai .htm> Y. Ito et al, Automated microfluidic assay system for autoantibodies found in autoimmune diseases using a photoimmobilized autoantigen microarray, Biotechnol.Prog. 24, American Institute of Chemical Engineers, 1384-1392 (2008).

There is a strong demand for on-the-spot high-precision determination of multi-item allergens, and expectations for POCT are high.
However, in the immunochromatography method described in Patent Document 2 applicable to POCT, three or less allergens can be used at one time. In addition, the immunochromatography method has a problem that the detection sensitivity and accuracy are apt to decrease. Therefore, the immunochromatography method described in Patent Document 2 has a problem that it can be used only as a very simple screening method.
Further, the microarray chip method described in Non-Patent Document 5 has a problem that the step of injecting the reagent into the flow path on the slide substrate is complicated, and it is not easy to reduce the size of the apparatus. In Non-Patent Document 5, it takes 30 minutes or more for the inspection.

  Further, in the configurations of Patent Documents 3 and 4, when draining the liquid in the chip, the liquid is sucked out of the chip using a nozzle. Here, the liquid has surface tension and viscosity, and the flowability of the liquid is different. Therefore, at the time of drainage, it is necessary to change the position of the nozzle and suck the inside of the chip many times, which causes a problem that time and labor are easily taken. Further, in the configuration in which the liquid is suctioned by the nozzle, there is a limit in the suction force and the suction range, so that the liquid in the chip cannot be completely sucked, and there is a problem that the liquid remains to some extent. Therefore, in Patent Literatures 3 and 4, there is also a problem that a reagent remaining after draining after washing affects the luminescence reaction and the like, causing background noise, and lowering the determination accuracy. In addition, in the configurations of Patent Documents 3 and 4, the chip is not covered with a seal or the like, so that there is a problem that a foreign substance intrudes into the chip and a sample liquid or a reagent is easily scattered from the chip.

The first technical object of the present invention is to improve the determination accuracy and reduce the inspection time.
Further, a second technical object of the present invention is to improve operability and enhance safety.

In order to solve the technical problem, the inspection system according to the invention according to claim 1,
A turntable that can rotate around the center of rotation,
A test base supported by the turntable, a storage part capable of storing a liquid test sample, and the detection target disposed when the test sample contains a component to be detected in the storage part. A spot on which a component that reacts with the component is fixed, a drain portion disposed radially outside of the storage portion with respect to the rotation center, and separation for separating the storage portion and the drain portion. A test substrate having:
A rotation drive mechanism for rotating the turntable,
A cleaning liquid supply unit that supplies a cleaning liquid to the storage unit of the test base,
When the cleaning liquid is supplied via the rotation driving mechanism, the liquid containing at least one of the cleaning liquid and the test sample moves from the storage section to the drainage section. die rotate, and control means drainage Before moving the liquid to the drainage unit,
When the liquid is drained from the container to the drainage unit by centrifugal force, an observation member that observes a spot in the container,
It is characterized by having.

According to a second aspect of the present invention, in the inspection system according to the first aspect,
Absorber that absorbs the liquid that has moved into the drainage unit is disposed in the drainage unit,
It is characterized by having.

According to a third aspect of the present invention, in the inspection system according to the first or second aspect,
A testing base to which the cleaning liquid is supplied from above in the direction of gravity of the storage section, the transparent coating member covering the storage section and the drain section from above, a supply port in which the test sample and the cleaning fluid and is formed in a member liquid is supplied, and a non-overlapping and wherein provided at a position corresponding to the accommodating part and the supply port to the spot when viewed from above The test substrate having:
The observation member disposed above the turntable,
It is characterized by having.

According to a fourth aspect of the present invention, in the inspection system according to any one of the first to third aspects,
An inclined surface inclined upward in the direction of gravity from the storage portion toward the drainage portion, and a wall portion extending from the end of the inclined surface toward the drainage portion toward the bottom surface of the storage portion , Said separating unit having
It is characterized by having.

According to a fifth aspect of the present invention, in the inspection system according to any one of the first to fourth aspects,
When the cleaning liquid is supplied, said the turntable is rotated at a rotational speed for non-discharge of the liquid acts residence capable centrifugal force to the receptacle, after in flowing the liquid in said containing portion control means before Sharing, ABS solution for rotating the turntable with the rotational speed for the discharge of the centrifugal force the liquid to move to the drainage portion from the receiving portion is applied,
It is characterized by having.

According to a sixth aspect of the present invention, in the inspection system according to any one of the first to fifth aspects,
A second turntable that supports the inspection base and is rotatably supported by the turntable;
It is characterized by having.

According to a seventh aspect of the present invention, in the inspection system according to any one of the first to fourth aspects,
Vibration source in contact with the test substrate, applying vibration to agitate said liquid in said containing portion to the test substrate,
It is characterized by having.

According to an eighth aspect of the present invention, in the inspection system according to any one of the first to seventh aspects,
A cleaning liquid supply unit and a reagent supply unit configured by a cartridge having a plurality of liquid containers in which the cleaning liquid or the reagent liquid supplied to the storage unit of the test substrate is subdivided and stored,
It is characterized by having.

In order to solve the technical problem, the inspection method of the invention according to claim 9,
A storage portion capable of storing a liquid test sample, and a spot in which a component that is arranged in the storage portion and reacts with the detection target component when the test sample contains the detection target component is fixed, a drainage portion disposed adjacent to the receiving portion, and a separation unit for separating the said housing portion drainage unit, the test査基body that have a, rotatable turntable around a rotation center In response, a step of arranging the liquid drain portion radially outward with respect to the rotation center with respect to the storage portion and supporting the drainage portion on the turntable,
Supplying a test sample to the test base;
Supplying a cleaning liquid to the storage section of the test substrate,
When the cleaning liquid is supplied, the liquid including at least one of the cleaning liquid and the test sample is rotated at a rotation speed at which a centrifugal force is applied to move the liquid from the storage unit to the drainage unit. A draining step of moving a liquid to the draining section,
A step of observing a spot in the storage section when the liquid is drained from the storage section;
Is performed.

According to the first and ninth aspects of the present invention, the accuracy of determination can be improved and the inspection time can be reduced as compared with the case where the liquid is not drained by applying a centrifugal force.
According to the second aspect of the present invention, the outflow of the liquid can be reduced, the operability can be improved, and the safety can be improved, as compared with the case where the absorber is not provided.
According to the third aspect of the present invention, operability can be improved and safety can be improved as compared with the case where no covering member is provided. Further, it is possible to suppress the supply port from adversely affecting spot observation, and it is possible to improve determination accuracy.

According to the fourth aspect of the present invention, it is possible to easily hold the liquid in the storage portion and to suppress the once drained liquid from returning to the storage portion as compared with a case without the configuration of the present invention. . As a result, the determination accuracy can be improved.
According to the fifth aspect of the present invention, the liquid in the storage section can be mixed with the cleaning liquid and drained together with the cleaning liquid more easily than when the cleaning liquid does not flow in the storage section.
According to the sixth aspect of the present invention, the bias of the centrifugal force acting on the test substrate can be suppressed, and the liquid can be appropriately stirred.

According to the invention described in claim 7, the liquid can be stirred in a shorter time than in the case of stirring by centrifugal force.
According to the invention described in claim 8, the configuration can be simplified as compared with the case where the liquid is supplied using a nozzle or a pump.

FIG. 1 is an overall explanatory diagram of a diagnostic system according to a first embodiment of the present invention. FIG. 1A is an explanatory diagram when a rotating station is moved to an observation position, and FIG. 1B is an explanatory diagram when a rotating station is moved to a cleaning liquid position. It is. FIG. 2 is an explanatory diagram of the rotating station according to the first embodiment of the present invention, and is an explanatory diagram when the rotating station moves to a zero point position. FIG. 3 is an explanatory diagram of the positioning sensor. FIG. 4 is an explanatory view of the chip cassette according to the first embodiment of the present invention. FIG. 4A is a plan view, and FIG. 4B is a sectional view taken along the line IVB-IVB in FIG. 4A. FIG. 5 is an explanatory diagram showing the functions of the personal computer according to the first embodiment of the present invention in a block diagram (functional block diagram). FIG. 6 is a flowchart of the reaction observation process according to the first embodiment of the present invention. FIG. 7 is a flowchart of the reaction rotation process according to the first embodiment of the present invention, which is a subroutine of ST2 in FIG. FIG. 8 is a flowchart of the cleaning process according to the first embodiment of the present invention, which is a subroutine of ST3 or ST5 in FIG. FIG. 9 is a flowchart of the cleaning drainage process according to the first embodiment of the present invention, which is a subroutine of ST206 in FIG. FIG. 10 is a flowchart of the antibody reagent process according to the first embodiment of the present invention, which is a subroutine of ST4 in FIG. FIG. 11 is a flowchart of the antibody reagent reaction rotation process according to the first embodiment of the present invention, which is a subroutine of ST405 in FIG. FIG. 12 is a flowchart of the luminescent reagent process according to the first embodiment of the present invention, which is a subroutine of ST6 in FIG. FIG. 13 is a flowchart of the imaging process according to the first embodiment of the present invention, which is a subroutine of ST7 in FIG. FIG. 14 is a flowchart of the end process according to the first embodiment of the present invention, which is a subroutine of ST8 in FIG. FIG. 15 is a flowchart of the end drainage process according to the first embodiment of the present invention, which is a subroutine of ST701 in FIG. FIG. 16 is a diagram illustrating the operation of the first embodiment of the present invention. FIG. 16A is a diagram illustrating a state in which a liquid is supplied to a reaction area. FIG. 16B is a diagram illustrating a state in which a cleaning liquid is supplied to FIG. 16A. FIG. 16C is an explanatory diagram of the case where the medium speed is rotated from FIG. 16B, and FIG. 16D is an explanatory diagram of the case where the high speed rotation is performed from FIG. 16C. FIG. 17 is an explanatory diagram of the experimental result of Experimental Example 1. FIG. 18 is an explanatory diagram of the experimental results of Experimental Example 2 and Comparative Example 1. 19 is an explanatory diagram of the experiment of Experimental Example 3, FIG. 19A is an explanatory diagram of a spot allergen, FIG. 19B is an explanatory diagram of an observation result of a first sample liquid, and FIG. 19C is an observation result of a second sample liquid. FIG. 19D is an explanatory diagram of the observation result of the third sample liquid. 20 is an explanatory diagram of the observation results of Experimental Example 4, FIG. 20A is a diagram showing the relationship between the signal intensity of the standard sample liquid and the CAP value, FIG. 20B is an enlarged view of a main part of a portion where the CAP value is small in FIG. 20A, FIG. 20C is a diagram showing the relationship between signal intensity and CAP value when measuring mite allergen. FIG. 21 is an explanatory diagram of Experimental Example 6, FIG. 21A is an explanatory diagram of a spot arrangement position, and FIG. 21B is an explanatory diagram of an observation result of a chip cassette. FIG. 22 is an explanatory view of the chip cassette according to the second embodiment of the present invention. FIG. 22A is a plan view corresponding to FIG. 4A of the first embodiment, and FIG. 22B is a cross-sectional view taken along the line XXIIB-XXIIB in FIG. FIG. 4B is a diagram corresponding to FIG. 4B of the first embodiment. FIG. 23 is an explanatory view of a main part of a diagnostic system according to the third embodiment of the present invention. FIG. 23A is an explanatory view of a rotating station, and FIG. FIG. 23C is an explanatory view of the coil spring on the rotating station of FIG. 23B. FIG. 24 is an explanatory diagram of a main part of the diagnostic system according to the fourth embodiment of the present invention.

Next, specific examples (hereinafter, referred to as examples) of embodiments of the present invention will be described with reference to the drawings, but the present invention is not limited to the following examples.
To facilitate understanding of the following description, in the drawings, the front-rear direction is the X-axis direction, the left-right direction is the Y-axis direction, the up-down direction is the Z-axis direction, and arrows X, -X, Y, -Y, The directions or sides indicated by Z and -Z are front, rear, right, left, upper, lower, or front, rear, right, left, upper, and lower, respectively.
Also, in the figure, those with “•” in “○” mean arrows pointing from the back of the paper to the front, and those with “x” in “○” indicate the arrow on the paper. From the back to the back.
In the following description using drawings, members other than members necessary for the description are omitted as appropriate for easy understanding.

FIG. 1 is an overall explanatory diagram of a diagnostic system according to a first embodiment of the present invention. FIG. 1A is an explanatory diagram when a rotating station moves to an observation position, and FIG. 1B is an explanatory diagram when a rotating station moves to a cleaning liquid position. It is.
FIG. 2 is an explanatory diagram of the rotating station according to the first embodiment of the present invention, and is an explanatory diagram when the rotating station moves to a zero point position.

(Description of diagnostic device S1)
(Description of rotating station 1)
As an example of the testing device, a diagnostic device S1 that can be used for diagnosis of an allergy test has a rotating station 1 as an example of a turntable. The rotation station 1 is formed in a disk shape having a thickness in the vertical direction. On the upper surface of the rotating station 1, a setting section 2 as an example of an installation section is formed. The setting unit 2 is formed at a position radially separated from the center 1 a of the disk of the rotating station 1. The set section 2 is formed in a concave shape corresponding to a chip cassette S2 as an example of an inspection base. The chip cassette S2 is detachably supported by the setting section 2.

  The center 1a of the rotating station 1 is supported by a rotating shaft 3 that is oriented in the vertical direction. That is, the longitudinal direction of the rotating shaft 3 is along the vertical direction. The lower end of the rotating shaft 3 is an example of a first drive mechanism, and is rotatably supported by a rotation mechanism 4 as an example of a rotation drive mechanism. Drive is transmitted to the rotation shaft 3 from a stepping motor 6 as an example of a drive source of a rotation mechanism 4. The stepping motor 6 is an example of an information processing device, and is electrically connected to a personal computer PC as an example of a control device, and its driving is controlled by the personal computer PC. Therefore, the rotation station 1 is rotated by the driving of the stepping motor 6.

FIG. 3 is an explanatory diagram of the positioning sensor.
In FIGS. 1 and 3, a positioning sensor 11 as an example of an initial position detecting member is disposed on the left side of the rotating station 1. The positioning sensor 11 detects a detection target 12 provided in the rotation station 1. The detected part 12 is arranged corresponding to a case where the setting part 2 on the rotating station 1 moves to a zero point position P1 as an example of the initial position shown in FIGS. That is, when the rotation station 1 moves to the zero point position P1, the detected portion 12 is arranged at a position where the sensor 11 detects the rotation. The positioning sensor 11 and the detected part 12 constitute a position detecting mechanism 13 of the first embodiment.
The rotational movement of the rotation station 1 is controlled based on the zero point position P1. In FIG. 2, the rotating station 1 is provided for each of the positions P2 to P5 corresponding to the case where the setting unit 2 moves to a preset observation position P2, a washing liquid position P3, an antibody reagent position P4, and a luminescent reagent position P5. It is rotated by a preset rotation angle with reference to the zero point position P1.

(Description of the nozzle device 21)
In FIGS. 1 and 2, a nozzle device 21 as an example of a supply device is disposed above the rotation station 1. The nozzle device 21 has nozzles 22, 23, and 24 as an example of a supply unit. Each of the nozzles 22 to 24 is arranged on the same circumference around the rotation shaft 3. In FIG. 2, a cleaning liquid nozzle 22 as an example of a cleaning liquid supply unit is disposed on the right front side corresponding to the cleaning liquid position P3. The nozzle 23 of the antibody reagent container as an example of the antibody reagent supply unit is disposed on the right rear side in correspondence with the antibody reagent position P4. Further, the nozzle 24 of the luminescent reagent container as an example of the luminescent reagent supply unit is disposed on the left rear side in correspondence with the luminescent reagent position P5.

  In FIG. 1B, each of the nozzles 22 to 24 is supported by a support member 26. The support member 26 is supported by a nozzle elevating mechanism 27 as an example of a second driving mechanism so as to be able to move up and down. Therefore, each of the nozzles 22 to 24 is configured to be able to move up and down integrally with the support member 26. Therefore, each of the nozzles 22 to 24 is configured to be movable between an injection position shown in FIG. 1B as an example of a descending position and a retracted position (not shown) as an example of an ascending position. Drive is transmitted to the support member 26 from a stepping motor 28 of a lifting mechanism 27. The stepping motor 28 is electrically connected to a personal computer PC, and its driving is controlled by the personal computer PC.

  In FIG. 1B, the cleaning liquid nozzle 22 has a discharge port 22a formed at a lower end and a supply port 22b formed at an upper end. One end of a tube 29 as an example of a tube is connected to the supply port 22b. The other end of the tube 29 is connected to a tank 31 as an example of a storage unit. The tank 31 stores the cleaning liquid L1. Further, a pump 32 as an example of a supply drive source is connected to the tank 31. A personal computer PC is electrically connected to the pump 32, and the drive of the pump 32 is controlled by the personal computer PC. Therefore, the cleaning liquid L1 can be supplied from the tank 31 to the cleaning liquid nozzle 22 through the tube 29. That is, the cleaning liquid L1 can be supplied and injected into the chip cassette S2 from the discharge port 22a of the cleaning liquid nozzle 22.

  A liquid antibody reagent L2 can be supplied and injected into the chip cassette S2 from the nozzle 23 of the antibody reagent container. Further, a liquid luminescent reagent L3 can be supplied and injected into the chip cassette S2 from the nozzle 24 of the luminescent reagent container. The configuration in which the antibody reagent L2 is supplied to the nozzle 23 of the antibody reagent container and supplied to the chip cassette S2, and the configuration in which the luminescent reagent L3 is supplied to the nozzle 24 of the luminescent reagent container and supplied to the chip cassette S2, The cleaning liquid L1 is supplied and supplied into the chip cassette S2. Therefore, a detailed description of the configuration for supplying the reagents L2 and L3 from the nozzle 23 of the antibody reagent container and the nozzle 24 of the luminescent reagent container is omitted.

  Here, in the tank 31 ′ of the nozzle 23 of the antibody reagent container of Example 1, as an example of the antibody reagent, a reagent solution for labeling an anti-IgE antibody to which horseradish peroxidase (HRP) is added as a labeling agent. It is stored. In addition, as an example of the luminescent reagent, a luminescent reagent solution obtained by mixing a reagent solution containing hydrogen peroxide and a reagent solution containing luminol is stored in the tank 31 ″ of the nozzle 24 of the luminescent reagent container of the first embodiment. As the luminescent reagent, a one-component reagent such as alkaline phosphatase can also be used.

  In the first embodiment, the antibody reagent L2 and the luminescent reagent L3 are stored in the tanks 31 ′ and 31 ″, and the reagents L2 and L3 are supplied from the tanks 31 ′ and 31 ″. However, the present invention is not limited to this. . For example, a configuration using a reagent container as an example of a container filled with a reagent is possible. The reagent container is a container filled with a reagent that is easily denatured and hard to store, and is used up once to improve convenience and the like. That is, the nozzles 23 and 24 may be configured to replace the tubes 29 ′ and 29 ″ and the tanks 31 ′ and 31 ″ and replace and mount the reagent containers for each chip cassette S 2. At this time, a configuration in which the reagent container itself has the function of the nozzles 23 and 24 is also possible.

(Description of Camera Device 41)
1 and 2, a camera device 41 as an example of an observation device is arranged above the left portion of the rotation station 1 in correspondence with the observation position P2. The camera device 41 is an example of a support member, and has a frame 42 as an example of a frame. The frame 42 supports a camera 43 as an example of an observation member and an example of a main body of the observation device. The camera 43 has a lens 44 as an example of an optical system, and a CCD 46 as an example of an image sensor that receives light passing through the lens 44. The CCD 46 is electrically connected to a personal computer PC. That is, the image captured by the CCD 46 is transmitted to the personal computer PC.

  A camera hood 47 as an example of a dark box member is disposed outside the camera 43 in the front-rear and left-right directions. The camera hood 47 is formed in a cylindrical shape extending in the up-down direction, and the inner circumference of the cross section is configured to be larger than the outer circumference of the set portion 2. The camera hood 47 is vertically movably supported along a guide portion 48 provided on the frame 42. The camera hood 47 supports a rack portion 49 extending vertically as an example of a transmitted portion. A gear 51 as an example of a transmission unit meshes with the rack unit 49. The gear 51 is supported by a drive shaft 52a of a motor 52. The motor 52 is configured to be rotatable forward and backward. The motor 52 is electrically connected to a personal computer PC, and its driving is controlled by the personal computer PC.

Therefore, when the motor 52 is driven forward and backward, the drive is transmitted to the camera hood 47 via the gear 51 and the rack 49, and the camera hood 47 is provided with a cover position as an example of a lowered position of the dark box and a raised position of the dark box as shown in FIG. 1A. 1B as an example. In the first embodiment, when the camera hood 47 moves to the covering position, the lower end contacts the upper surface of the rotating station 1. At this time, the camera hood 47 shields light and blocks light from entering the camera 43 from outside.
The guide portion 48, the rack portion 49, the gear 51, and the motor 52 constitute a hood elevating mechanism 53 as an example of the third drive mechanism of the first embodiment. The frame 42, the camera 43, the camera hood 47, and the hood elevating mechanism 53 constitute the camera device 41 of the first embodiment.

(Description of Temperature Control Mechanism 61)
In FIG. 1, a temperature control mechanism 61 is disposed below the rotating station 1. The temperature control mechanism 61 has a disk 62 as an example of a support member. The disk 62 is fixedly arranged close to the lower surface of the rotating station 1. A micro heater 63 as an example of a temperature raising member is supported on the upper surface of the disk 62. The micro heater 63 heats the lower surface of the rotating station 1 and the chip cassette S2. The temperature control mechanism 61 has a temperature sensor 64 as an example of an environmental temperature detecting member. The temperature control mechanism 61 of the first embodiment is electrically connected to the personal computer PC, and controls the micro heater 63 based on the detected temperature. The temperature control mechanism 61 of the first embodiment holds the lower surface of the rotating station 1 and the chip cassette S2 at a preset temperature. In the first embodiment, the angle is maintained at 38 degrees as an example.
The diagnostic device S1 according to the first embodiment includes the rotation station 1, the rotation mechanism 4, the position detection mechanism 13, the nozzle device 21, the camera device 41, the temperature control mechanism 61, and the like. The diagnostic apparatus S, the chip cassette S2, the personal computer PC, and the like constitute a diagnostic system S as an example of the inspection system of the first embodiment.

(Description of chip cassette S2)
FIG. 4 is an explanatory view of the chip cassette according to the first embodiment of the present invention. FIG. 4A is a plan view, and FIG. 4B is a sectional view taken along the line IVB-IVB in FIG. 4A.
In FIG. 4, a chip cassette S2 as an example of an inspection base has a flat substrate 101. The substrate 101 is formed in a square shape. A hydrophobic ring 102 is formed on the upper surface 101a of the substrate 101, which is an example of a separating portion, and is an example of a hydrophobic portion. The hydrophobic ring 102 is formed in an annular shape having a preset width. The hydrophobic ring 102 has been subjected to a hydrophobic treatment, and has a higher hydrophobicity than the other upper surface 101a. In the first embodiment, the hydrophobic ring 102 is formed by applying a hydrophobic material to the upper surface 101a in an annular shape. The configuration of such a hydrophobic ring 102 is conventionally known, and for example, the configuration described in JP-A-2013-24605 is applicable. Therefore, detailed description of the hydrophobic ring 102 is omitted.

  4A, an upper surface 101a of the substrate 101 is separated into an inner region and an outer region by a hydrophobic ring. A region inside the hydrophobic ring 102 constitutes a reaction area A1 which is an example of a storage section and an example of a reaction region. Further, a region outside the hydrophobic ring 102 constitutes a drainage area A2 which is an example of a drainage portion and an example of a drainage region. That is, the drainage area A2 of the first embodiment has a region located radially outside the reaction area A1 with respect to the rotation center 3. The reaction area A1 and the drainage area A2 are adjacent to each other with the hydrophobic ring 102 interposed therebetween.

  In the reaction area A1, a plurality of spots 103 in which components that react with the components to be detected are fixed when the components to be detected are contained in the liquid test sample. The spots 103 are arranged on the upper surface 101a of the substrate 101 at predetermined intervals in a predetermined direction. In the first embodiment, in FIG. 4A, two spots are arranged in the front-back direction and four rows in the left-right direction, and a total of eight spots 103 are arranged. Here, the diagnosis system S of the first embodiment is configured to be capable of diagnosing an allergy test. Therefore, in the first embodiment, as an example of a liquid test sample, a test sample that can contain an antibody as a component to be detected is used. Specifically, a sample liquid L0 based on blood collected from a subject is used. As the sample liquid L0, any of whole blood, serum, and plasma can be used, and those obtained by diluting them with a buffer can also be used as the sample liquid L0. Further, in the spot 103 of Example 1, an antigen which is a component reacting with the antibody is added and fixed to the spot 103 in a large amount. In the first embodiment, an extract of an allergen or a recombinant allergen is immobilized on the spot 103 as an example of the antigen. Note that the number and arrangement of the spots 103 are not limited to the above-described configuration, and any number and arrangement can be used. In addition, the number of spots 103 is desirably eight or more from the viewpoint of simultaneous inspection of many items.

In the drainage area A2, a cassette retaining wall 104 as an example of a side wall of the base is supported. The cassette retaining wall 104 has an outer wall portion 106 formed in a square cylindrical shape along the outer periphery of the substrate 101. The outer wall 106 extends upward. A rectangular plate-shaped upper bottom portion 107 is supported on the upper end 106a of the outer wall portion 106. In FIG. 4A, a circular hole 107 a that is concentric with the hydrophobic ring 102 and larger than the hydrophobic ring 102 is formed in the upper bottom portion 107. The upper bottom 107 supports a cylindrical inner wall 108 extending downward from the inner periphery of the hole 107a. The lower end 108a of the inner wall 108 is separated from the substrate 101 at a predetermined interval.
The outer wall portion 106, the upper bottom portion 107, and the inner wall portion 108 constitute the cassette retaining wall 104 of the first embodiment.

  In FIG. 4B, a holding space 109 according to the first embodiment is configured by a space surrounded by the substrate 101, the outer wall 106, the upper bottom 107, and the inner wall 108. Further, the gap between the inner wall portion 108 and the substrate 101 forms the water absorption groove 111 of the first embodiment. Therefore, the holding space 109 is spatially connected to the drainage area A2 via the water absorption groove 111. The holding space 109 contains a water absorbing agent 112 as an example of an absorber. The water absorbing agent 112 absorbs the liquid moved to the water absorbing groove 111. In addition, as the water absorbing agent 112, for example, silica gel can be used. The absorbent is not limited to a drug such as a water-absorbing agent, and it is also possible to use a liquid-absorbable member such as absorbent cotton in the Japanese Pharmacopoeia.

On the upper surface 107b of the cassette retaining wall 104, a square plate-shaped seal 113 as an example of a covering member is supported. The seal 113 is made of a transparent member. Therefore, when the upper surface 101a is observed from above, the spot 103 on the substrate 101 can be observed via the seal 113. In the seal 113, an injection hole 113a as an example of a supply port is formed corresponding to the reaction area A1. In FIG. 4A, when viewed from above, in the first embodiment, the injection hole 113 a is formed at a position that does not overlap with the spot 103. An identification seal (not shown) as an example of an identification display member is affixed to the upper surface of the seal 113 in a position that does not overlap with the reaction area A1 and that corresponds to a position where an image can be captured by the camera 43. A bar code as an example of an identifier is displayed on the identification sticker, and is imaged by the camera 43 together with the spot 103. Therefore, in the first embodiment, the barcode is read by the camera 43. The barcode is used for associating the subject with the chip cassette S2 on a one-to-one basis. As the identifier, a two-dimensional code, character information, or the like can be used instead of a one-dimensional barcode.
The substrate 101, the hydrophobic ring 102, the spot 103, the cassette retaining wall 104, the water absorbing agent 112, the seal 113, and the like constitute the chip cassette S2 of the first embodiment.

  Note that the substrate 101 and the seal 113 of the chip cassette S2 are made of a material having no birefringence and no light absorption in the visible light region and having excellent optical characteristics. In particular, the substrate 101 is desirably a glass substrate, a silicon substrate, or a plastic substrate surface-treated for immobilizing proteins. Among these substrates, a substrate coated with a light-fixing polymer is particularly desirable. Note that the substrate coated with the light-fixing polymer is described in International Publication No. WO2009 / 119082, and thus detailed description is omitted.

(Description of PC)
FIG. 5 is an explanatory diagram showing the functions of the personal computer according to the first embodiment of the present invention in a block diagram (functional block diagram).
In FIG. 5, the personal computer PC according to the first embodiment is configured by a so-called computer device, which is an example of a computer main body H1, an example of a display, a touch panel H2 as an example of an input unit, and a non-volatile semiconductor (not shown). It is composed of a memory, a so-called flash memory or the like.

The computer main body H1 of the personal computer PC stores I / O (input / output interface) for inputting / outputting signals with the outside and adjusting input / output signal levels, and programs and data for performing necessary startup processing. ROM (Read Only Memory), RAM (Random Access Memory) for temporarily storing necessary data and programs, CPU (Central Processing Unit) for performing processing according to a boot program stored in ROM or the like, and It has a clock oscillator and the like, and various functions can be realized by executing programs stored in the ROM, RAM and the like.
The personal computer PC configured as described above can realize various functions by executing programs stored in the flash memory, the ROM, or the like.
In the computer main body H1, basic software for controlling basic operations, that is, an operating system OS, a reaction observation program as an application program, and other software (not shown) are stored in a hard disk drive (HDD), a solid state drive (SSD), or the like. Have been.
The computer main body H1 has a communication function, and is configured to be able to transmit and receive information to and from another information processing device via a communication line.

(Signal output element connected to computer main body H1)
Output signals of the following signal output elements H2, 11, 46 and 64 are input to the computer main body H1.
H2: Touch Panel The touch panel H2 detects an input to the touch panel H2 and inputs a detection signal to the computer main body H1.
11: Positioning Sensor The positioning sensor 11 inputs a detection signal indicating whether or not the rotation station 1 has moved to the zero point position P1 to the computer main body H1.
46: CCD
The CCD 46 inputs a captured image signal to the computer main body H1.
64: Temperature Sensor The temperature sensor 64 inputs the environmental temperature to the computer main body H1.

(Controlled element connected to computer main body H1)
The computer main body H1 outputs control signals for the following controlled elements H2, D1 to D7.
H2: Touch Panel The touch panel H2 displays an image based on the image signal transmitted from the computer main body H1.
D1: Rotary drive circuit The rotary drive circuit D1 as an example of a first drive circuit drives the stepping motor 6 of the rotating mechanism 4 to rotate the rotating station 1.
D2: Nozzle Elevating Circuit The nozzle elevating circuit D2 as an example of the second drive circuit drives the stepping motor 28 of the nozzle elevating mechanism 27 in the normal and reverse directions to move the nozzles 22 to 24 up and down.
D3: Hood Elevating Circuit The hood elevating circuit D3 as an example of the third drive circuit drives the stepping motor 52 of the hood elevating mechanism 53 forward and backward to move the camera hood 47 up and down.

D4: Driving Circuit of Cleaning Pump A driving circuit D4 of the cleaning pump as an example of a driving circuit of the first supply driving source drives the pump 32 to discharge the cleaning liquid L1 from the cleaning liquid nozzle 22.
D5: Driving Circuit of Antibody Pump The driving circuit D5 of the antibody pump as an example of the driving circuit of the second supply driving source drives the pump 32 'to discharge the antibody reagent L2 from the nozzle 23 of the antibody reagent container. .
D6: Driving Circuit of Luminescent Pump The driving circuit D6 of the luminescent pump as an example of the driving circuit of the third supply driving source drives the pump 32 ″ to discharge the luminescent reagent L3 from the nozzle 24 of the luminescent reagent container. .
D7: Temperature control circuit The temperature control circuit D7 activates the micro heater 63 and detects the environmental temperature with the temperature sensor 64.

(Functions of the computer body H1)
The computer main body H1 has a reaction observation program for controlling operations of the controlled elements H2, D1 to D7, and the like according to output signals of the signal output elements H2, 11, 46, 64, and the like.

(Reaction observation program AP1 of Example 1)
The reaction observation program AP1 as an example of the inspection program has the following functional units (program modules).

C1: Reaction rotation means Reaction rotation means C1, which is an example of first control means of the turntable, and which is an example of rotation means of a first rotation speed, rotates the rotation station 1 via a rotation drive circuit D1. Let it. The reaction rotation unit C1 rotates the rotation station 1 at a non-discharge rotation speed N1 at which a centrifugal force that allows the liquid to stay in the reaction area A1 acts. The reaction rotation unit C1 rotates the rotation station 1 at a preset first rotation speed N1 as an example of a non-discharge rotation speed. When rotating based on the input of the input unit H2 of the personal computer PC, the reaction rotation unit C1 of the first embodiment rotates the rotation station 1 for a preset reaction time T0 of the sample liquid. Further, when the reaction rotating means C1 of the first embodiment is rotated when the antibody reagent L2 is injected, it rotates the rotating station 1 for a preset time T0 'for reaction of the antibody reagent. The rotation speed N1 and the times T0 and T0 'are set in advance based on experiments and the like. In the first embodiment, the time T0 for the reaction of the sample liquid is set to 8 minutes as an example. The time T0 'for the reaction of the antibody reagent is set to 4 minutes as an example.

  In the first embodiment, the configuration in which the single rotation speed N1 is used as the non-discharge rotation speed is exemplified, but the invention is not limited to this. For example, the number of revolutions at which a centrifugal force at which the liquid can stay in the reaction area A1 acts and the number of revolutions at which the centrifugal force at which the liquid moves from the reaction area A1 to the drainage area A2 acts as a threshold value for the discharge rotation. For the number N11, the non-discharge rotational speeds N1 ', N1 "are set as rotational speeds satisfying 0 <N1' <N1" <Na. Then, within the reaction time T0, T0 ', the rotation is initially performed at the non-discharge small rotation speed N1', and after a preset time has elapsed, the rotation is changed to the non-discharge large rotation speed N1 ". It is also possible to change from N1 "to N1 'and rotate. Further, a configuration is also possible in which the number of revolutions is changed stepwise from 0 toward Na within the reaction times T0 and T0 '. In other words, a configuration is also possible in which the reaction rotation means C1 controls the rotation speed to be variable using a plurality of non-discharge rotation speeds within the reaction times T0 and T0 '.

  When the reaction rotation unit C1 varies the rotation speed using a plurality of non-discharge rotation speeds, the rotation direction is not limited to a fixed direction, and a configuration in which the rotation is performed in the opposite direction is also possible. . In other words, a configuration is also possible in which the stepping motor 6 is configured to be capable of normal and reverse rotation, and the reaction rotation means C1 is rotated while switching the rotation direction at an appropriate time set in advance. Therefore, for example, when the time T0 for the reaction of the sample liquid is 8 minutes, the rotation direction is switched every two minutes. The first two minutes are forward rotation of the rotation speed N1, and the next two minutes are rotation. It is also possible to adopt a configuration in which the number of rotations N1 is reversed, the rotation for the next two minutes is the normal rotation of the rotation number N1, and the last two minutes is the rotation for the rotation N1. Similarly, for example, when the time T0 'for the reaction of the antibody reagent is 4 minutes, the rotation direction is switched every minute, the first minute is the normal rotation of the rotation speed N1, and the next minute is the first rotation. It is also possible to adopt a configuration in which the rotation speed N1 is reversed, the next one minute is the rotation speed N1 in the normal rotation, and the last one minute is the rotation speed N1 in the reverse rotation. Note that a configuration in which the rotation speeds N1 to N1 ″ for non-discharge and the rotation speed 0 are repeated, that is, a configuration in which rotation and stop are repeated and stirring is performed is also possible.

  Further, the time for the reaction rotating means C1 to rotate using the respective non-discharge rotational speeds is not limited to a configuration in which the reaction times T0 and T0 'are equally divided. For example, when the reaction time T0 is set to 8 minutes and the rotation speeds N1 'and N1 "are used as the non-discharge rotation speeds, the rotation is performed at N1' for 4 minutes and the rotation at N1" is performed for 4 minutes. Then, it is of course possible to adopt a configuration in which the rotation is performed for a total of 8 minutes. It is also possible to change the rotation of N1 'and N1 "every two minutes and rotate it every 30 seconds, and rotate each of them for four minutes, for a total of eight minutes. Instead of these, it is also possible to have a configuration in which the motor is rotated for 6 minutes at N1 'and for 2 minutes at N1 ", for a total of 8 minutes. Further, it is also possible to rotate at N1 'for 4 minutes first, then at N1 "for 1 minute, and finally rotate at N1' for 3 minutes, for a total of 8 minutes. When C1 is controlled by changing the rotation speed using a plurality of non-discharge rotation speeds, the order of the rotation speed and the rotation direction are set so that the reaction times T0 and T0 'as a whole. It is possible to make the rotation speed variable by arbitrarily assigning the rotation time.

C2: Rotating means for cleaning drainage The rotating means C2 for cleaning drainage, which is an example of a control unit for draining cleaning liquid, is an example of a second control unit of the turntable. Means C2B and high-speed rotating means C2C. The washing drainage rotating means C2 rotates the rotating station 1 via a rotating drive circuit D1. When the washing liquid L1 is supplied, the washing drain rotating means C2 rotates the rotating station 1 at a non-discharge rotational speed N1 at which a centrifugal force that allows the liquid to stay in the reaction area A1 acts. The liquid flows in the reaction area A1. Further, the rotating means C2 for cleaning and draining the liquid is rotated at a rotation speed N1 for non-discharge, and then the rotation speeds N2 and N3 for discharge where centrifugal force is applied to move the liquid from the reaction area A1 to the drainage area A2. To rotate the rotation station 1 to drain the liquid.

C2A: Low-speed rotation means The low-speed rotation means C2A as an example of the rotation means of the first rotation number has the same first rotation number N1 as the reaction rotation means C1 as an example of the non-discharge rotation number, and has a rotation station. Rotate 1 The low-speed rotation means C2A of the first embodiment rotates the rotation station 1 for a preset low-speed time T1 when the cleaning liquid L1 is injected into the chip cassette S2 and the nozzle 22 moves to the retreat position. The rotation speed N1 and the time T1 are set in advance based on experiments and the like. In the low-speed rotation unit C2A of the first embodiment, the configuration in which the low-speed rotation is performed using the single rotation speed N1 is exemplified, but the invention is not limited to this. For example, similarly to the reaction rotation unit C1, the low-speed rotation unit C2A controls the rotation speed of the low-speed rotation variably, for example, by using a plurality of rotation speeds from 0 to the rotation speed Na within the time T1. It is also possible. At this time, the low-speed rotation means C2A arbitrarily assigns the order of the number of rotations, the rotation direction, and the rotation time so that the low-speed time T1 as a whole may vary the low-speed rotation speed. Is possible.

C2B: Medium-speed rotation unit The medium-speed rotation unit C2B as an example of the rotation unit of the second rotation speed is a preset second rotation speed larger than the first rotation speed N1 as an example of the discharge rotation speed. The rotation station 1 is rotated at the rotation speed N2. The medium speed rotation means C2B of the first embodiment rotates the rotation station 1 for a preset medium speed time T2. The medium-speed rotation unit C2B of the first embodiment rotates the rotation station 1 when the control of the low-speed rotation unit C2A ends. The rotation speed N2 and the time T2 are set in advance based on experiments and the like. In the first embodiment, the medium speed rotation unit C2B is configured to perform the medium speed rotation using the single rotation speed N2. However, the configuration is not limited to this. For example, like the reaction rotating unit C1, the medium-speed rotating unit C2B includes a plurality of rotating speeds Na ranging from the low-speed and medium-speed thresholds to the medium-speed and high-speed thresholds Nb within the time T2. It is also possible to control the rotation speed of the medium-speed rotation by using a variable rotation speed, for example. At this time, the medium-speed rotation means C2B arbitrarily assigns the order of the number of rotations, the rotation direction, and the rotation time so that the medium-speed rotation time T2 as a whole, and varies the rotation speed of the medium-speed rotation. It is possible to

C2C: High-speed rotation unit The high-speed rotation unit C2C as an example of the rotation unit of the third rotation number is a preset third rotation number larger than the second rotation number N2 as an example of the discharge rotation number. At N3, the rotation station 1 is rotated. The high-speed rotation unit C2C of the first embodiment rotates the rotation station 1 for a preset high-speed time T3. The high-speed rotation unit C2C of the first embodiment rotates the rotation station 1 when the control of the medium-speed rotation unit C2B ends. The rotation speed N3 and the time T3 are set in advance based on experiments and the like. In the high-speed rotation unit C2C of the first embodiment, the configuration in which the high-speed rotation is performed using the single rotation speed N3 is exemplified, but the invention is not limited thereto. For example, similarly to the reaction rotation unit C1, the high-speed rotation unit C2C makes the rotation speed of the high-speed rotation variable, such as using a plurality of rotation speeds larger than the rotation speed Nb of the medium speed and the high speed within the time T3. Can also be controlled. At this time, the high-speed rotation means C2C may arbitrarily assign the order of the number of rotations, the rotation direction, and the rotation time so that the high-speed rotation T3 as a whole may vary the rotation speed of the high-speed rotation. Is possible.

C3: Rotating means for terminating drainage The rotating means C3 for terminating drainage, which is an example of control means for draining the luminescent reagent, and which is an example of third control means for the turntable, has high-speed rotating means C3A. The ending drainage rotating means C3 is provided with a centrifugal force for moving the luminescent reagent L3 from the reaction area A1 to the drainage area A2 when the observation of the camera 43 is completed via the rotation driving circuit D1. The rotation station 1 is rotated at the rotation speed N3, and the luminescent reagent L3 is moved to the drainage area A2.
C3A: High-speed rotating means The high-speed rotating means C3A is a high-speed rotating means C2 for cleaning and draining except that the rotating station 1 is rotated when the observation of the camera 43 is completed and the camera hood 47 is moved to the open position. It has the same configuration as the rotating means C2C. Therefore, a detailed description of the high-speed rotation means C3A is omitted.

C4: Position Control Means The position control means C4 as an example of the fourth control means of the turntable rotates the rotation station 1 via the rotation drive circuit D1 to move the rotation station 1 to the positions P1 to P5. In the first embodiment, when moving the rotation station 1 to the zero point position P1, the position control means C4 rotates the rotation station 1 until the positioning sensor 11 detects that the rotation station 1 has moved to the zero point position P1. To move the rotary station 1 to the positions P2 to P5, a pulse is input to the stepping motor 6 by a rotation angle corresponding to each of the positions P2 to P5 based on the zero point position P1. Thereby, the position control means C4 of the first embodiment moves the rotation station 1 to each of the positions P1 to P5.

  Here, in the first embodiment, when the sample liquid L0 reacts with the spot 103, the position control means C4 moves the rotating station 1 to the cleaning liquid position P3. When the washing of the sample liquid L0 is completed, the position control means C4 moves the rotating station 1 to the antibody reagent position P4. Further, when the antibody reagent L2 and the spot 103 react, the position control means C4 moves the rotation station 1 to the cleaning liquid position P3. When the washing of the antibody reagent L2 is completed, the position control means C4 moves the rotating station 1 to the luminescent reagent position P5. Further, when the luminescent reagent L3 reacts with the spot 103, the position control means C4 moves the rotating station 1 to the observation position P2. When the observation is completed and the drainage processing is completed, the position control means C4 moves the rotating station 1 to the zero point position P1.

C5: Nozzle Elevating Means The nozzle elevating means C5 as an example of the supply unit moving means moves the nozzles 22 to 24 up and down via the nozzle elevating circuit D2. The nozzle elevating means C5 of the first embodiment lowers the nozzles 22 to 24 to the injection position when the rotating station 1 moves to the washing liquid position P3, the antibody reagent position P4, and the luminescent reagent position P5. Further, the nozzle elevating means C5 of the first embodiment raises the nozzles 22 to 24 to the retreat position when the supply of the liquid from the nozzles 22 to 24 is completed.

C6: Cleaning Liquid Supply Means The cleaning liquid supply means C6 as an example of the cleaning liquid supply control means drives the pump 32 to supply the cleaning liquid L1 from the cleaning liquid nozzle 22 to the reaction area A1 of the chip cassette S2. The cleaning liquid supply means C6 supplies the cleaning liquid L1 when the time T0 has elapsed since the sample liquid L0 was supplied to the reaction area A1. Further, when the time T0 'has elapsed since the supply of the antibody reagent L2 to the reaction area A1, the cleaning liquid L1 is supplied. Specifically, when the rotating station 1 moves to the cleaning liquid position P3 and the cleaning liquid nozzle 22 moves to the injection position, the cleaning liquid supply means C6 of the first embodiment transfers the cleaning liquid L1 from the cleaning liquid nozzle 22 into the cassette chip S2. Inject into

C7: Antibody Reagent Supply Means The antibody reagent supply means C7 as an example of an antibody reagent supply control means drives the pump 32 'to move the antibody reagent from the nozzle 23 of the antibody reagent container to the reaction area A1 of the chip cassette S2 from the nozzle 23. Supply L2. The antibody reagent supply means C7 supplies the antibody reagent L2 to the reaction area A2 when the sample liquid L0 is drained together with the washing liquid L1. Specifically, when the rotation station 1 moves to the antibody reagent position P4 and the antibody reagent container nozzle 23 moves to the injection position, the antibody reagent container nozzle 23 , The antibody reagent L2 is injected into the chip cassette S2.

C8: Luminescent Reagent Supply Means The luminescent reagent supply means C8 as an example of the luminescent reagent supply control means drives the pump 32 ″ to move the luminescent reagent from the nozzle 24 of the luminescent reagent container to the reaction area A1 of the chip cassette S2. The luminescent reagent supply means C8 supplies the luminescent reagent L3 when the antibody reagent L2 in the reaction area A1 is drained together with the washing liquid L1. The supply means C8 injects the luminescent reagent L3 into the chip cassette S2 from the luminescent reagent container nozzle 24 when the rotating station 1 moves to the luminescent reagent position P5 and the luminescent reagent container nozzle 24 moves to the injection position. .

C9: Hood Elevating Means The hood elevating means C9, which is an example of dark box member control means, raises and lowers the camera hood 47 via a hood elevating circuit D3. The hood lifting / lowering means C9 of the first embodiment lowers the camera hood 47 to the covering position when the rotation station 1 moves to the observation position P2. Further, the hood lifting / lowering means C9 of the first embodiment raises the camera hood 47 to the open position when the imaging by the camera 43 ends.
C10: Image Storage Unit The image storage unit C10 as an example of an imaging control unit stores an image captured by the CCD 46 during a preset time T11.

C11: Image Analysis Unit The image analysis unit C11 as an example of the image processing unit performs an analysis process on a captured image. The image analysis unit C11 according to the first embodiment specifies the position of the spot 103 in the captured image data based on the position data of the designed spot 103 stored in advance. Then, an average intensity value of the spot is calculated based on the signal intensity of the image sensor constituting the specified spot 103. That is, the image analysis means C11 of Example 1 measures the average intensity value as being proportional to the concentration of the specific IgE antibody in the sample corresponding to the antigen of the spot 103. Instead of the average intensity value, the maximum signal intensity value, or the intermediate value between the maximum signal intensity value and the neighboring value of the spot is calculated as a value proportional to the specific IgE antibody concentration in the sample. You may. Further, the image analysis unit C11 of the first embodiment also performs a barcode reading process of the chip cassette S2 based on the image data captured by the camera 43. That is, the image analysis unit C11 according to the first embodiment specifies the subject from the barcode of the imaged image data based on the correspondence information between the identifier registered and stored in advance and the subject information. Therefore, in the first embodiment, the subject is prevented from mixing the measurement results.

C12: Display Unit The display unit C12 displays the measurement result processed by the image analysis unit C11 on the touch panel H2. The display unit C12 according to the first embodiment displays a captured image, an average intensity value of each spot 103 in the captured image data, and subject information. In addition, the maximum intensity value or the intermediate value can be displayed.
Note that the configuration of the image analysis unit C11 and the display unit C12 is not limited to a configuration that displays luminance and numerical values, and a conventionally known image analysis, such as displaying spots on image data in different colors for each spot intensity, and the like. In addition, an image display configuration can be applied.
C13: Number-of-times discriminating means The number-of-times discriminating means C13 has a counter CT for counting the number of times J from the supply of the cleaning liquid to the drainage of the cleaning liquid. Then, the number-of-times determining means C13 determines whether or not the number of times of processing J is larger than a preset threshold value J0.

C14: Time discriminating means The time discriminating means C14 has a timer TM for measuring the times T0, T0 ', T1, T2, T3, and T11. Then, the time determining means C14 determines whether or not the time T0 to T11 has expired.
C15: Temperature control means The temperature control means C15 controls the micro heater 63 via the temperature control circuit D7 based on the temperature detected by the temperature sensor 64, and sets the lower surface of the rotary station 1 and the chip cassette S2 in advance. Hold at temperature.

(Description of Flowchart of First Embodiment)
Next, the flow of processing of each program of the personal computer PC of the first embodiment will be described using a flowchart.

(Explanation of the flow chart of the reaction observation process)
FIG. 6 is a flowchart of the reaction observation process according to the first embodiment of the present invention.
The processing of each ST (step) in the flowchart of FIG. 6 is performed according to a program stored in the HDD or the like of the computer main body H1. This process is executed by multitasking in parallel with other various processes of the computer main body H1.

The flowchart shown in FIG. 6 is started when the reaction observation program AP1 is started in the personal computer PC.
In ST1 of FIG. 6, it is determined whether or not a start input has been made from the input unit H2 of the personal computer PC. If yes (Y), the process proceeds to ST2, and if no (N), ST1 is repeated.
In ST2, the reaction rotation processing shown in FIG. 7 is executed. Then, the process proceeds to ST3.
In ST3, the cleaning process shown in FIG. 8 is performed. Then, the process proceeds to ST4.
In ST4, the antibody reagent processing shown in FIG. 10 is performed. Then, the process proceeds to ST5.
In ST5, the cleaning process shown in FIG. 8 is performed. Then, the process proceeds to ST6.
In ST6, the luminescent reagent process shown in FIG. 12 is executed. Then, the process proceeds to ST7.
In ST7, the imaging process shown in FIG. 13 is executed. Then, the process proceeds to ST8.
In ST8, the end processing shown in FIG. 14 is executed. Then, the process returns to ST1.

(Explanation of the flowchart of the reaction rotation process)
FIG. 7 is a flowchart of the reaction rotation process according to the first embodiment of the present invention, which is a subroutine of ST2 in FIG.
In ST101 of FIG. 7, the following processes (1) and (2) are executed. Then, the process proceeds to ST102.
(1) Start low-speed rotation.
(2) Set the time T0 for the reaction.
In ST102, it is determined whether or not the reaction time T0 has elapsed. If yes (Y), the process proceeds to ST103, and if no (N), ST102 is repeated.
In ST103, the low-speed rotation ends. Then, the reaction rotation process ends, and the process returns to ST (step) of the calling process.

(Explanation of the flowchart of the cleaning process)
FIG. 8 is a flowchart of the cleaning process according to the first embodiment of the present invention, which is a subroutine of ST3 or ST5 in FIG.
In ST201 of FIG. 8, J = 0. That is, the counter J is initialized. Then, the process proceeds to ST202.
In ST202, the rotation station 1 is moved to the cleaning liquid position P3. Then, the process proceeds to ST203.
In ST203, the nozzles 22 to 24 are moved to the injection position. Then, the process proceeds to ST204.
In ST204, the cleaning liquid L1 is injected into the chip cassette S2. Then, the process proceeds to ST205.
In ST205, the nozzles 22 to 24 are moved to the standby positions. Then, the process proceeds to ST206.
In ST206, the cleaning drainage processing shown in FIG. 9 is executed. Then, the process proceeds to ST207.
In ST207, J = J + 1. That is, 1 is added to J. Then, the process proceeds to ST208.
In ST208, it is determined whether or not the counter J is equal to or larger than the threshold value J0. If the determination is yes (Y), the cleaning process is terminated, and the process returns to ST (step) of the calling process. If the determination is no (N), the process returns to ST202.

(Explanation of the flow chart of the cleaning drainage process)
FIG. 9 is a flowchart of the cleaning drainage process according to the first embodiment of the present invention, which is a subroutine of ST206 in FIG.
In ST301 of FIG. 9, the following processes (1) and (2) are executed. Then, the process proceeds to ST302.
(1) Start low-speed rotation.
(2) Set the low-speed time T1.
In ST302, it is determined whether or not the low-speed time T1 has expired. If yes (Y), the process proceeds to ST303, and if no (N), the process repeats ST302.
In ST303, the low-speed rotation ends. Then, the process proceeds to ST304.
In ST304, the following processes (1) and (2) are executed. Then, the process proceeds to ST305.
(1) Start medium speed rotation.
(2) Set the medium speed time T2.
In ST305, it is determined whether or not the medium speed time T2 has elapsed. If yes (Y), the process proceeds to ST306, and if no (N), ST305 is repeated.
In ST306, the medium-speed rotation ends. Then, the process proceeds to ST307.

In ST307, the following processes (1) and (2) are executed. Then, the process proceeds to ST308.
(1) Start high-speed rotation.
(2) Set the high-speed time T3.
In ST308, it is determined whether or not the high-speed time T3 has expired. If yes (Y), the process proceeds to ST309, and if no (N), ST308 is repeated.
In ST309, the high-speed rotation ends. Then, the cleaning and draining process is completed, and the process returns to the calling source process ST (step).

(Explanation of the flowchart of antibody reagent processing)
FIG. 10 is a flowchart of the antibody reagent process according to the first embodiment of the present invention, which is a subroutine of ST4 in FIG.
In ST401 of FIG. 10, the rotation station 1 is moved to the antibody reagent position P4. Then, the process proceeds to ST402.
In ST402, the nozzles 22 to 24 are moved to the injection position. Then, the process proceeds to ST403.
In ST403, the antibody reagent L2 is injected. Then, the process proceeds to ST404.
In ST404, the nozzles 22 to 24 are moved to the standby positions. Then, the process proceeds to ST405.
In ST405, the reaction rotation process of the antibody reagent shown in FIG. 11 is executed. Then, the antibody reagent process ends, and the process returns to ST (step) of the calling process.

(Explanation of the flowchart of the reaction rotation process of the antibody reagent)
FIG. 11 is a flowchart of the reaction rotation process of the antibody reagent according to the first embodiment of the present invention, which is a subroutine of ST405 in FIG.
In the step ST101 'of the reaction rotation process of the antibody reagent in FIG. 11, the time T0' for the reaction of the antibody reagent is used instead of the time T0 for the reaction of the sample liquid. And different. Other processes are the same as the processes in FIG. 7, and thus detailed description of the antibody reagent reaction rotation process is omitted.

(Explanation of flowchart of luminescent reagent processing)
FIG. 12 is a flowchart of the luminescent reagent process according to the first embodiment of the present invention, which is a subroutine of ST6 in FIG.
In ST501 of FIG. 12, the rotating station 1 is moved to the luminescent reagent position P5. Then, the process proceeds to ST502.
In ST502, the nozzles 22 to 24 are moved to the injection position. Then, the process proceeds to ST503.
In ST503, the luminescent reagent L3 is injected. Then, the process proceeds to ST504.
In ST504, the nozzles 22 to 24 are moved to the retreat position. Then, the luminescent reagent process is completed, and the process returns to ST (step) of the calling process.

(Explanation of flowchart of imaging process)
FIG. 13 is a flowchart of the imaging process according to the first embodiment of the present invention, which is a subroutine of ST7 in FIG.
In ST601 of FIG. 13, the rotating station 1 is moved to the observation position P2. Then, the process proceeds to ST602.
In ST602, the camera hood 47 is moved to the covering position. Then, the process proceeds to ST603.

In ST603, the following processes (1) and (2) are executed. Then, the process proceeds to ST604.
(1) Start imaging.
(2) An imaging time T11 is set.
In ST604, it is determined whether or not the imaging time T11 has elapsed. If yes (Y), the process proceeds to ST605, and if no (N), ST604 is repeated.
In ST605, the imaging ends. Then, the process proceeds to ST606.
In ST606, the camera hood 47 is moved to the open position. Then, the imaging process ends, and the process returns to ST (step) of the calling process.

(Explanation of the flowchart of the end processing)
FIG. 14 is a flowchart of the end process according to the first embodiment of the present invention, which is a subroutine of ST8 in FIG.
In ST701 of FIG. 14, the end drainage processing shown in FIG. 15 is executed. Then, the process proceeds to ST702.
In ST702, the rotation station 1 is moved to the zero point position P1. Then, the termination process is terminated, and the process returns to ST (step) of the process of the caller.

(Explanation of the flowchart of the end drainage process)
FIG. 15 is a flowchart of the end drainage process according to the first embodiment of the present invention, which is a subroutine of ST701 in FIG.
15 is different from the cleaning drainage processing of FIG. 9 in that the steps ST301 to ST306 of the cleaning drainage processing are omitted. The other processing is the same as the processing in FIG. 9, and a detailed description of the end drainage processing will be omitted.

(Operation of First Embodiment)
In the diagnostic system S of the first embodiment having the above-described configuration, the chip cassette S2 is set at the zero point P1 in the rotating station 1 of the diagnostic device S1. When the tip cassette S2 is set in the diagnostic apparatus S1, the tip cassette S2 of the first embodiment is an example of a supply unit of a test sample, and is injected using a pipette Pi shown in FIG. 1B as an example of an injection instrument. A test sample is injected from the hole 113a. In the first embodiment, a sample liquid L0 based on blood collected from a subject is injected as an example of a test sample. Therefore, the sample liquid L0 is dropped on the reaction area A1 of the chip cassette S2.
In the setting section 2 of the rotating station 1, the temperature is maintained at a preset temperature by the temperature control mechanism 61. Therefore, in the reaction area A1, the sample liquid L0 and the spot 103 easily react. When the processing start is input by the personal computer PC, the reaction observation processing shown in FIG. 6 is executed in the diagnostic device S1.

16A and 16B are diagrams illustrating the operation of the first embodiment of the present invention, FIG. 16A is a diagram illustrating a state where a liquid is supplied to a reaction area, and FIG. 16B is a diagram illustrating a state where a cleaning liquid is supplied to FIG. 16A. FIG. 16C is an explanatory diagram of the case where the medium speed is rotated from FIG. 16B, and FIG. 16D is an explanatory diagram of the case where the high speed rotation is performed from FIG. 16C.
In the diagnostic device S1, when the processing start is input, the rotating station 1 rotates at a low speed during the time T0. Therefore, the chip cassette S2 rotates at a low speed together with the rotation station 1. At this time, a centrifugal force acts on the sample liquid L0 on the chip cassette S2. However, in the first embodiment, the first rotation speed N1 is set to a non-discharge rotation speed at which the sample liquid L0 has a centrifugal force that does not exceed the hydrophobic ring 102 due to the action of surface tension or cohesion. I have. Therefore, as shown in FIG. 16A, the sample liquid L0 flows and is stirred in the reaction area A1 without passing through the hydrophobic ring 102. At this time, when a component to be detected, that is, an antibody specific to the antigen of the spot 103 is present in the sample liquid L0, the antibody reacts with the antigen of the spot 103 to generate a so-called antigen-antibody reaction. Note that the antigen is fixed as the spot 103 and can react with the antigen with a small amount of the sample liquid L0 as compared with the conventional configuration in which the antigen is not fixed at the spot 103.

In Example 1, the reaction time T0 is set to a time sufficient for an antigen-antibody reaction to occur. In addition, a large amount of antigen is added and fixed to each spot 103, and a decrease in unreacted antigen due to the progress of the antigen-antibody reaction with the antibody in the sample liquid L0 may be ignored. As a result, the amount of specific IgE bound to the spot 103 is almost proportional to the concentration in the sample. Therefore, it can be said that the sample liquid L0 is suppressed from becoming unreacted with the antigen of the spot 103, even though the specific antibody is contained in the sample liquid L0. When the time T0 has elapsed, the rotating station 1 moves to the cleaning liquid position P3.
When the rotation station 1 moves to the cleaning liquid position P3, the nozzle 22 moves to the injection position. That is, as shown in FIG. 16B, the lower end 22a of the cleaning liquid nozzle 22 enters the chip cassette S2 from the injection hole 113a. Then, the cleaning liquid L1 is supplied from the cleaning liquid nozzle 22 to the reaction area A1. When a predetermined amount of the cleaning liquid L1 is supplied, the cleaning liquid nozzle 22 moves to the retracted position. In the first embodiment, in addition to the cleaning liquid nozzle 22, the nozzles 23 and 24 also move up and down integrally. Therefore, the number of elevating mechanisms is smaller than that of individually raising and lowering the nozzles 22 to 24, and the configuration of the diagnostic device S1 is simplified and downsized. In addition, the number of elevating mechanisms is small, and costs are easily reduced.

When the cleaning liquid L1 is injected, a cleaning drainage process is performed. In the cleaning and drainage processing, the rotation station 1 rotates at a low speed during the low-speed time T1. Therefore, as shown in FIG. 16B, the sample liquid L0 and the cleaning liquid L1 flow in the reaction area A1. Therefore, the sample liquid L0 and the washing liquid L1 are stirred and diluted, and the sample liquid L0 and the washing liquid L1 are adapted. The time T1 is set to a time during which the liquid to be cleaned is sufficiently stirred and diluted with the cleaning liquid L1 to become familiar.
After the elapse of the time T1, the rotation station 1 is rotated at the second rotation speed N2 at a medium speed. Here, the second rotation speed N2 is set to the rotation speed for discharge, and the centrifugal force is such that the liquids L0 and L1 move from the reaction area A1 through the hydrophobic ring 102 to the drainage area A2. It is set as follows. Therefore, when rotated at a medium speed, as shown in FIG. 16C, the mixed liquid of the sample liquid L0 and the cleaning liquid L1 gently crosses the hydrophobic ring 102. Therefore, the liquids L0 and L1 are discharged from the reaction area A1 and move to the drainage area A2 between the hydrophobic ring 102 and the cassette retaining wall 104.

  When the medium speed time T2 set to a time sufficient for the liquid to move from the reaction area A1 elapses, the rotation station 1 is rotated at a high speed at the third rotation speed N3. The third rotation speed N3 is set to a discharge rotation speed higher than the second rotation speed N2. Therefore, the centrifugal force also increases, and the liquid remaining in the drainage area A2 and the reaction area A1 moves toward the cassette retaining wall 104 by the action of the centrifugal force. Then, the liquids L0 and L1 are absorbed by the water absorbing agent 112 in the holding space 109 via the drain groove 111 of the cassette retaining wall 104. Thus, the liquid is removed from the reaction area A1 and the drainage area A2, and the drainage of the chip cassette S2 ends. The high-speed rotation is continued until the high-speed time T3 elapses. The high-speed time T3 is set to a time during which the liquid moved from the drainage area A2 or the like is sufficiently absorbed by the water absorbing agent 112. Therefore, it is difficult for the liquid to remain in the drainage area A2 and the like. In the first embodiment, the processing from supplying the cleaning liquid L1 to discharging the cleaning liquid L1 is repeated a plurality of times.

  Here, in the conventional configuration in which the liquid is suctioned by the nozzle and drained, as in the configurations described in Patent Documents 3 and 4, the suction force hardly reaches only near the nozzle. In addition, the surface tension and viscosity of the liquid act on the liquid. Therefore, when the liquid is sucked and moved, the liquid may run out and may be separated on the way, and a part of the liquid may remain. Therefore, in order to reduce the remaining liquid, it was necessary to repeat the process of changing the position of the nozzle and sucking the remaining liquid. Therefore, in the conventional automated device, a mechanism for specifying the position where the liquid remains and moving the nozzle to adjust the position of the remaining liquid is required, and the device is easily enlarged, and the drainage is also performed. Is also time-consuming. Moreover, even with such a configuration, it is difficult to completely remove the liquid with the nozzle. In general, in the cleaning process, if the cleaning liquid is supplied only once, the liquid to be removed is only diluted, and the cleaning is likely to be insufficient. Therefore, it is likely to need to repeat the process of supplying and draining the cleaning liquid a plurality of times. Therefore, in the conventional configuration, there is a problem that drainage takes time and labor, and the entire process is unnecessarily long.

  On the other hand, in the first embodiment, the liquid is drained using the centrifugal force generated by the rotation of the rotation station 1. That is, by using centrifugal force, the liquid is directed from the reaction area A1 and the drainage area A2 to the cassette retaining wall 104 and is absorbed by the water absorbing agent 112 in the cassette retaining wall 104. Here, in the first embodiment, the centrifugal force acts regardless of the position or distribution of the liquid. Therefore, unlike the conventional configuration, it is possible to move all the liquids in the reaction area A1 and the drainage area A2 by rotating the rotation station 1. Therefore, there is no need to move the liquid by repeating the suction operation. Therefore, in the first embodiment, drainage processing is easier than in the conventional configuration in which suction is performed by the nozzle. Therefore, in the first embodiment, the processing of the drainage liquid is easily completed in a short time.

  Furthermore, in the first embodiment, the liquid remaining in the areas A1 and A2 is easily reduced by adjusting the centrifugal force. That is, in the first embodiment, a plurality of rotation speeds N1 to N3 are used to apply different magnitudes of centrifugal force to drain the cleaning liquid L1 and the like. That is, first, the sample liquid L0 and the cleaning liquid L1 are adapted to each other in the reaction area A1 by performing low-speed rotation, so that the sample liquid L0 is easily drained. Thereafter, the liquids L0 and L1 are gently discharged from the reaction area A1 to the drainage area A2 at a medium speed. Here, when the medium speed rotation is omitted and the liquid is suddenly discharged at a high speed, a large centrifugal force acts on the liquids L0 and L1 in the reaction area A1. Therefore, there is a possibility that the droplets are easily generated, and the droplets adhere to the seal 113 above the reaction area A1. Further, the liquid shortage phenomenon easily occurs, and the liquid may remain in the reaction area A1. On the other hand, in the first embodiment, after the liquid is gently moved to the drainage area A2 at the medium speed rotation, the high speed rotation is performed. Therefore, a large centrifugal force is acting in a state where the liquid remaining in the reaction area A1 is small, and the possibility that the droplets adhere to the seal 113 of the reaction area A1 to be soiled or the liquid remains in the reaction area A1 is suppressed. Have been. Therefore, in the first embodiment, the degree of achievement of drainage and cleaning is high. Therefore, in the first embodiment, it is easy to reduce the number of times J0 of repeating the processing from supplying the cleaning liquid L1 to draining the liquid, and also shortening the processing time spent for the entire inspection. Further, since the number of times J0 for repeating the cleaning is reduced, the amount of the supplied cleaning liquid L1 can be reduced, and the total amount of the drained liquid can be easily reduced.

In the first embodiment, the position of the setting unit 2 is formed at a position radially separated from the rotation shaft 3. Therefore, the liquids L0 and L1 in the chip cassette S2 tend to be far from the center of rotation, and the centrifugal force tends to increase even if the rotation speed of the rotating shaft 3 is the same. Therefore, in the first embodiment, it is easier to drain the liquid at a lower rotation speed than in the case where the setting unit 2 exists on the rotation center.
Further, in the conventional configuration, a tube or a tank for drainage is required. On the other hand, in the first embodiment, the liquid is absorbed by the water absorbing agent 112 in the chip cassette S2 and is held. Therefore, in the first embodiment, a tube and a tank for drainage are omitted. Therefore, the diagnostic device S1 is simplified and downsized as compared with the conventional configuration. In addition, there is no need for a drain tank or the like, and the cost is easily reduced. In the first embodiment in which the drainage tank is omitted, the operation of discarding the liquid from the drainage tank is unnecessary, and the workability and operability of the diagnostic system S are easily improved.

  In addition, Patent Document 4 describes that a tip cassette is tilted or a liquid is blown and sprayed when performing a drainage process. However, these configurations require a tilting configuration and a blowing configuration in addition to the configuration for moving the chip cassette. Therefore, the apparatus becomes complicated, and the whole apparatus is easily increased in size. On the other hand, in the first embodiment, the liquid in the chip cassette S2 is also moved using the rotation of the rotation station 1 that moves the chip cassette S2. That is, in the first embodiment, the mechanism for moving the chip cassette S2 and the mechanism for moving the liquid in the chip cassette S2 are shared. Therefore, in the first embodiment, the entire configuration is simplified and downsized.

  In the first embodiment, a chip cassette S2 having a water absorbing agent 112, a seal 113, and the like is used. Here, as in Patent Documents 3 and 4, a configuration of a chip cassette in which the spot 103 is exposed to the outside, that is, a so-called open chip configuration is also conceivable. However, in the open chip, when a centrifugal force acts, the sample liquid L0, the cleaning liquid L1, and the like may be scattered outside. Therefore, there is a possibility that the diagnostic device S1, the inspection environment, and the worker may be contaminated. Further, there is a possibility that foreign matter may enter the chip or the operator may touch the reaction areas A1 and A2 when the chip is mounted on the rotating station 1. Further, there is a possibility that a liquid such as the sample liquid L0 evaporates during the processing. Therefore, in the case of the open chip, the spot 103 may be damaged or the sample liquid may be insufficient, which may adversely affect the inspection accuracy. Therefore, in the case of an open chip, careful work is easily required, and workability and operability are likely to deteriorate.

  On the other hand, the chip cassette S2 of the first embodiment includes the water absorbing agent 112 and the seal 113. Therefore, the areas A1 and A2 are covered with the cassette retaining wall 104 and the seal 113, and even when a centrifugal force acts, the sample liquid L0, the cleaning liquid L1, and the like are prevented from scattering to the outside. Further, evaporation of the sample liquid L0 and the like is suppressed. In addition, the liquids L0 and L1 that have moved to the drainage area A2 are absorbed by the water absorbing agent 112 and held in the chip cassette S2. That is, the chip cassette S2 of the first embodiment has a closed configuration in which the liquid hardly flows out. Therefore, the chip cassette S2 of the first embodiment is easier to handle than the open chip, and the operability of the diagnostic system S is improved. In particular, in the first embodiment in which the number J0 of repeated washing is small and the amount of drainage is likely to be small, it is easy to prevent the drainage from leaking without being absorbed, and the space for storing the water-absorbing agent absorbing the drainage and the drainage. And the chip cassette S2 having a closed configuration can be preferably used while maintaining a compact configuration.

  When the washing of the sample liquid L0 is completed, the rotation station 1 moves to the antibody reagent position P4. In FIG. 16, at the antibody reagent position P4, the nozzle 23 of the antibody reagent container moves to the injection position, and the antibody reagent L2 is supplied and injected into the chip cassette S2. Therefore, in the reaction area A1, the labeled antibody reagent L2 reacts with the IgE antibody that has bound to the allergen of each spot 103 as an antigen-antibody, and a labeling reaction occurs. When the nozzle 23 of the antibody reagent container moves to the retreat position, the rotation station 1 rotates at a low speed during the time T0 '. Therefore, the antibody reagent L2 is stirred in the reaction area A1. Therefore, the reaction efficiency is improved. The time T0 'for the reaction is set to a time sufficient for the labeling reaction to occur. When the low-speed rotation at time T0 'ends, a washing process is performed, and the antibody reagent L2 is washed in the same manner as the sample liquid L0.

  When the antibody reagent L2 is washed, the rotation station 1 moves to the luminescent reagent position P5. At the luminescent reagent position P5, the nozzle 24 of the luminescent reagent container moves to the injection position, and the luminescent reagent L3 is supplied and injected into the chip cassette S2. Therefore, in the reaction area A1, the luminescent reagent L3 reacts with the spot 103 where the labeling reaction has occurred, and a chemiluminescent reaction occurs. That is, the spot 103 emits light in accordance with the amount of the antibody that has reacted with the antigen. When the nozzle 24 of the luminescent reagent container moves to the retreat position, the rotating station 1 moves to the observation position P2. When the rotation station 1 moves to the observation position P2, the camera hood 47 moves to the covering position, and shields the chip cassette S2 from the outside. Accordingly, the chip cassette S2 is closed by the dark box, and the light from the emitted spot 103 is imaged by the CCD 46 during the time T11.

  Here, in the first embodiment in which the cleaning process is performed using the centrifugal force, the degree of achievement of the cleaning is high, and the background noise in the captured image is easily reduced. Therefore, in the first embodiment, the inspection accuracy is likely to be higher than in the conventional configuration. In the first embodiment, high-speed rotation is performed after the liquid is gently discharged to the drainage area A2 at medium-speed rotation. Therefore, it is possible to prevent the splash from splashing above the reaction area A1 and soiling the seal 113. Therefore, it is also suppressed that the droplet generated by the centrifugal force adversely affects the observation of the spot 103. In particular, in FIG. 4A, the injection hole 113a of the seal of Example 1 does not overlap with the spot 103. Therefore, when the camera 43 captures an image from above, the light from the emitted spot 103 is not scattered by the injection hole 113a. Therefore, the position of the spot 103 is hardly shifted on the captured image, and the possibility that the position of the light-emitting spot 103 is erroneously recognized is reduced. Note that the substrate 101 and the seal 113 of Example 1 are made of a material having excellent optical characteristics. Therefore, high reliability of chemiluminescence measurement is easily secured.

The image captured by the camera 43 is analyzed. In the first embodiment, image data corresponding to the light emission intensity of the spot 103 and numerical data are displayed on the display H2. Therefore, the amount of the antibody in the sample liquid L0 can be determined.
When the imaging by the camera 43 ends, the camera hood 47 moves to the open position. Then, a process of draining the luminescent reagent L3 is performed. That is, the rotation station 1 rotates at a high speed for a high speed time T3. Thereby, the luminescent reagent L3 moves by centrifugal force and is absorbed by the water absorbing agent 112. When the luminescent reagent L3 is drained, only high-speed rotation is performed without performing low-speed rotation or medium-speed rotation. Therefore, the processing time for drainage is shortened. When drainage of the luminescent reagent L3 is completed, the rotating station 1 is moved to and held at the zero point position P1.

  Therefore, the chip cassette S2 can be removed from the diagnostic device S1, and the chip cassette S2 can be replaced. Note that the liquids L0 to L3 injected into the chip cassette S2 are absorbed by the water absorbing agent 112 and can be discarded for each chip cassette S2. Further, since the liquids L0 to L3 are absorbed by the water absorbing agent 112, when the chip cassette S2 is taken out from the diagnostic device S1 and carried, it is difficult for the liquids L0 to L3 to jump out of the water injection holes 113a. Therefore, in the first embodiment, the possibility that the liquids L0 to L3 flow out of the chip cassette S2 is reduced. Therefore, in the first embodiment using the chip cassette S2 having the closed configuration, the worker is less likely to touch the liquids L0 to L3, the spot 103, and the like than in the case of the open chip, and the safety is improved. Further, handling of the chip cassette S2 is facilitated, and operability is improved.

(Experimental example)
Next, an experiment for confirming the effect of the first embodiment was performed.
(Experimental example 1)
In Experimental Example 1, an experiment was performed to confirm whether the liquid in the chip cassette S2 can be removed by centrifugal force, that is, whether or not the liquid can be drained. In Experimental Example 1, the chip cassette was rotated at the rotation station 1, and the amount of liquid remaining in the chip cassette after rotation was measured. Here, in Experimental Example 1, the spot 103, the cassette retaining wall 104, the water absorbing agent 112, and the seal 113 of the chip cassette S2 were omitted, and a so-called bare substrate having only the substrate 101 and the hydrophobic ring 102 was used. . That is, the substrate of Experimental Example 1 was configured so that the liquid could scatter out of the substrate when a centrifugal force was applied. Then, based on the amount of change in the liquid before and after being rotated in the rotation station 1, the amount of the remaining liquid on the substrate was measured.

  Specifically, in Experimental Example 1, first, the weight α1 of the bare substrate is measured. Next, a predetermined amount α0 of the cleaning liquid is dropped into the reaction area A1. Then, after rotating the naked substrate after dropping in the rotation station 1, the weight α2 of the rotated naked substrate is measured. Therefore, the remaining liquid amount remaining on the substrate is measured as α2−α1. In Experimental Example 1, three types of cleaning liquids were used as cleaning liquids: TBS: Tris-Buffered Saline, TBST: Tris-buffered saline-Tween 20, and a dedicated cleaning liquid adjusted for the diagnostic system S. The inner diameter of the hydrophobic ring 102 was set to 18 [mm]. The weight was measured using an electronic balance, and the decrease in the liquid volume due to evaporation during the measurement was ignored.

FIG. 17 is an explanatory diagram of the experimental result of Experimental Example 1.
FIG. 17 shows the relationship between the rotation speed and the residual liquid amount when the rotation station 1 is rotated at the rotation speed. In FIG. 17, the horizontal axis represents the rotation speed [rpm], and the vertical axis represents the residual liquid amount [μL]. In FIG. 17, when the number of revolutions was close to 0, the residual liquid amount was the same for all of TBS, TBST, and the dedicated cleaning liquid. Also, the value does not change unless the number of rotations becomes larger than a certain value. Therefore, when the rotation speed was close to 0, it was confirmed that the amount α0 of the cleaning liquid supplied to the reaction area A1 was retained in the reaction area A1.

On the other hand, it was confirmed that when the rotation speed was high to some extent, the amount of residual liquid remaining on the substrate decreased as the rotation speed increased. At this time, TBS and TBST may remain more easily than the dedicated cleaning liquid in some cases. However, when the number of rotations increases, the residual liquid amount decreases in any of the cleaning liquids. In particular, it was confirmed that when the number of rotations was sufficiently higher than 1000, only about 1/1000 of the remaining liquid remained in any of the cleaning liquids when the number of rotations was close to zero.
Therefore, it was confirmed that the liquid can be removed from the chip cassette S2 by centrifugal force, and that the liquid can be drained by the diagnostic system S using centrifugal force. Further, it was also confirmed that in the diagnostic system S using the centrifugal force, drainage was possible regardless of the type of the cleaning liquid. In the diagnostic system S using the centrifugal force, it was also confirmed that the cleaning liquid could be held in the reaction area A1 or drained from the substrate by properly using the rotation speed.

(Experimental example 2)
In Experimental Example 2, an experiment was performed to examine the relationship between the number of cleaning steps and the degree of achievement of cleaning. In Experimental Example 2, a reaction observation process was performed using the diagnostic system S of Example 1, and the light emission intensity of the spot 103, that is, the signal intensity of the CCD 46 that received light from the spot 103 was observed. In Experimental Example 2, a chip cassette in which the spot 103 was omitted was used instead of the chip cassette S2 of Example 1. The inner diameter of the hydrophobic ring 102 was set to 18 [mm]. In Experimental Example 2, a labeled antibody reagent was added, and the time T0 'was 4 minutes, and the mixture was rotated at a low speed for stirring. Thereafter, a cleaning step of supplying the cleaning liquid and draining the cleaning liquid was performed. The number of times J0 for repeating the washing step was set to two times and ten times. Then, for each of the cases where the number of times the washing process was repeated was 2 times and 10 times, an integrated image of 60 seconds after the reaction of the luminescent reagent was taken, and the average signal intensity over the entire reaction area was determined as the background signal intensity. When the antibody reagent is supplied to the chip cassette, the higher the degree of achievement of the washing, the smaller the remaining amount of the antibody reagent. Therefore, the chemiluminescent reaction between the antibody reagent and the luminescent reagent decreases, and the observed background signal intensity decreases. Conversely, if the degree of achievement of the washing is low, the remaining amount of the antibody reagent increases and the chemiluminescence reaction with the luminescent reagent increases, so that the intensity of the observed background light increases. Therefore, it is possible to confirm the degree of achievement of the washing based on the intensity of the observed background signal intensity.

(Comparative Example 1)
In Comparative Example 1, the signal intensity was observed using the biochip automatic analysis system described in Patent Document 3 instead of the diagnostic system S of Example 1. That is, the comparative example 1 is different from the experimental example 2 in that the liquid is sucked and discharged by the nozzle. In Comparative Example 1, conditions and measurement methods other than those required for the system of the nozzle of Comparative Example 1 were the same as those in Experimental Example 2.

FIG. 18 is an explanatory diagram of the experimental results of Experimental Example 2 and Comparative Example 1.
In FIG. 18, in Comparative Example 1, the background signal intensity was about 5000 when the number of times of the washing process was repeated twice. When the number of times the cleaning process was repeated was increased to 10, the background light signal intensity was reduced to about 1000. Therefore, in Comparative Example 1 using a nozzle, it was confirmed that the cleaning step had to be repeated 10 times or more.
In contrast, in Experimental Example 2 using the diagnostic system S of Example 1, the background signal intensity was 500 or less regardless of whether the washing step was repeated twice or ten times. In particular, in Experimental Example 2, when the number of times the washing process was repeated was 10, the background signal intensity was 1/10 or less of the case where the number of times was 2. Therefore, it was confirmed that the cleaning system S of the first embodiment using the centrifugal force achieved a higher degree of cleaning than the nozzle configuration. Therefore, in the diagnostic system S of the first embodiment, the reagent rarely remains, and the background signal intensity is reduced. That is, it was confirmed that the inspection accuracy was improved. In addition, it was confirmed that the number of times of cleaning is smaller than that of the nozzle configuration, so that the inspection time can be shortened and the amount of cleaning liquid can be easily reduced.

(Experimental example 3)
19 is an explanatory diagram of the experiment of Experimental Example 3, FIG. 19A is an explanatory diagram of a spot allergen, FIG. 19B is an explanatory diagram of an observation result of a first sample solution, and FIG. 19C is an observation diagram of a second sample solution. FIG. 19D is an explanatory diagram of the observation result of the third sample liquid.
In Experimental Example 3, an experiment for detecting an anti-allergen antibody was performed. In Experimental Example 3, an experiment was performed by using a chip cassette S2 in which allergens were arranged as spots 103 and observing it with a diagnostic device S1. In FIG. 19A, in Experimental Example 1, a total of 24 spots 103, four vertically and six horizontally, were arranged. The six spots 103a in the first row are house dust mite, the six spots 103b in the second row are cats, the six spots 103c in the third row are milk, and the six spots 103d in the fourth row are 103d. Each antigen of the lamp was fixed. Then, the sample liquids derived from the three allergic patients A, B, and C were observed using the chip cassette S2.

  The observation results are shown in FIGS. 19B to 19D. As shown in FIG. 19B to FIG. 19D, it was confirmed that the signal intensity was different depending on the type of allergen when the patient was different. That is, it was confirmed that the concentration of the specific IgE antibody differs depending on the patient, but the signal intensity differs. Therefore, it was confirmed that the diagnostic system S of Example 1 can determine the concentration of the specific IgE antibody in the specimen for the allergen.

(Experimental example 4)
20 is an explanatory diagram of the observation results of Experimental Example 4, FIG. 20A is a diagram showing the relationship between the signal intensity of the standard sample solution and the CAP value, FIG. FIG. 20C is a diagram showing the relationship between signal strength and CAP value when measuring mite allergen.
In Experimental Example 4, an experiment was performed to examine the correlation between the signal intensity and the CAP value, that is, the correlation between the signal intensity measured using the diagnostic system S of the present application and the concentration measured using the CAP method. Was done.

  20A and 20B show signal intensities when a standard sample solution is used. Here, the standard sample solution is a sample solution prepared according to the determination classification based on the correlation with the CAP value. Specifically, class 0 (0 to 0.35: negative), class 1 (0.35 to 0.7: false positive), class 2 (0.7 to 3.5: weak positive), class 3 (3 CAP value indicating a boundary value of 0.5 to 17.5: positive, class 4 (17.5 to 50: positive), class 5 (50 to 100: strong positive), and class 6 (100 or more: strong positive) These are seven sample liquids whose IgE concentrations have been adjusted in advance so that The standard sample solution was used to prepare a standard curve for signal intensity calibration.

  FIG. 20C shows the results of measuring mite allergen using a plurality of different sample liquids collected from humans. That is, FIG. 20C shows the relationship between the signal intensity when the mite allergen is fixed as the spot 103 in the same chip cassette S2 as in Experimental Example 1 and the concentration of the mite-specific IgE antibody separately measured by the CAP method. . In FIG. 20C, the vertical axis indicates the signal intensity, and the horizontal axis indicates the CAP value. Therefore, from FIG. 20C, it was confirmed that the signal intensity observed by the diagnostic system S showed a high correlation with the value measured by the CAP method.

(Experimental example 5)
In Experimental Example 5, an experiment for measuring the coincidence rate of class determination was performed. The coincidence rate of determination classification classification based on the correlation between the four types of allergen data obtained by the diagnostic system S and the CAP values shown in FIG. 20 was measured. In Experimental Example 5, the class coincidence rate was measured for seven stages of class 0 to class 6.
Table 1 shows the measurement results. High class matching rates were obtained for ticks, cats, milk, and rump. Therefore, it was confirmed that the reliability of the multi-item simultaneous analysis of the diagnostic system S using the chip cassette S2 according to Example 1 was high.

(Experimental example 6)
FIG. 21 is an explanatory diagram of Experimental Example 6, FIG. 21A is an explanatory diagram of a spot arrangement position, and FIG. 21B is an explanatory diagram of an observation result of a chip cassette.
In Experimental Example 6, an experiment for detecting a virus antigen antibody was performed. In FIG. 21A, in Experimental Example 6, a detoxified virus (antigen) of measles, rubella, varicella, mumps, and EB (Epstein-Barr virus) was used, and an anti-IgG antibody was used as a positive control (positon in the figure). As a negative control (negative control in the figure), BSA (bovine serum albumin) was arranged in two spots a to g each. That is, spots a to g were arranged in the order of chickenpox, EB, mumps, rubella, negative control, positive control, and measles. The fixed amount of virus and the like is in the range of 0.5 [mg / mL] to 1.5 [mg / mL].
Then, a serum sampled and diluted from a human body was prepared, and a detection reaction was performed under the same conditions as in Experimental Example 3 except that IgG was used as the detection antibody.

  FIG. 21B shows the observation results. It can be seen that the signal intensity differs depending on the spots a to g, and the antibody titer differs for each virus. This antibody titer was confirmed to be consistent with the standard assay method EIA (enzyme immunoassay). Therefore, it was confirmed that the diagnostic system S of Example 1 of the present invention is applicable to tests other than allergy diagnosis. In particular, in the diagnostic system S of the first embodiment, the chip cassette S2 has a closed configuration, and operability and safety are improved. Therefore, it was confirmed that the method can be suitably applied to virus inspection.

(Summary)
Tables 2 and 3 below show differences between the examples and the configurations corresponding to Patent Documents 1 to 4 and Non-Patent Document 5 based on Experimental Examples 1 to 6.

  In Table 2, in Experimental Examples 3 to 6, the number of simultaneous inspection items is larger than in the MAST method or the microarray method. In Experimental Examples 3 to 6, the time from mounting the chip cassette S2 on the rotating station 1 and inputting the start until the chip cassette S2 is observed and returns to the zero point position is about 15 minutes. In contrast, the MAST method takes 6 hours, and the microarray method takes 30 minutes or more. Therefore, in Experimental Examples 3 to 6, the measurement time is shorter than in the conventional MAST method or microarray method. Further, the amount of the sample liquid is smaller than that of the MAST method or the microarray method. Therefore, it is understood that the embodiment of the present application is more useful than the MAST method or the microarray method.

  In Table 3, when the level was the same as that of Comparative Example 4 with Comparative Example 4 as a reference, X was added. In addition, when it was superior to Comparative Example 4, it was marked with a circle. Further, in the case where there is superiority to the structure marked with ○, ◎ is given. The configuration of the embodiment is superior to the comparative example 4 with respect to the number of inspection items, but is at the same level as the configurations of the comparative examples 5 and 6. However, as can be understood from Experimental Examples 1 and 2, in the present embodiment utilizing the centrifugal force, the inspection accuracy is improved and the inspection time is shortened as compared with the configurations of Comparative Examples 5 and 6 in which the liquid is drained by the nozzle. You. Further, in the embodiment of the present application, the chip cassette has a closed configuration, and operability and safety are improved as compared with Comparative Examples 5 and 6 of the open chip. In the configurations of Comparative Examples 5 and 6, a drain tank or the like is required because a nozzle is used. However, in the present embodiment, the drain tank is not required, and the size is easily reduced. In addition, the installation area of the diagnostic device S1 of Experimental Examples 3 to 6 can be realized with an A4 size. Therefore, in various points, it is understood that the configuration of the embodiment of the present application is more useful than the immunochromatography method and the configuration of the nozzle and the open chip.

Next, a description will be given of a second embodiment of the present invention. In the description of the second embodiment, the same reference numerals are given to components corresponding to the components of the first embodiment, and a detailed description thereof will be omitted. I do.
This embodiment is different from the first embodiment in the following points, but is configured similarly to the first embodiment in other points.

(Description of Chip Cassette S2 'of Second Embodiment)
FIG. 22 is an explanatory view of a chip cassette according to the second embodiment of the present invention. FIG. 22A is a plan view corresponding to FIG. 4A of the first embodiment, and FIG. 22B is a cross-sectional view taken along the line XXIIB-XXIIB in FIG. FIG. 4B is a diagram corresponding to FIG. 4B of the first embodiment.
In FIG. 22, a chip cassette S2 'as an example of the inspection base of the second embodiment is different from the hydrophobic ring 102 and the seal 113 of the chip cassette S2 of the first embodiment in that a hydrophobic inclined portion 102' and a seal 113 'are used. And

This is an example of the separation portion of the second embodiment, and a hydrophobic inclined portion 102 'as an example of a hydrophobic portion is formed in an annular shape. The hydrophobic inclined portion 102 'has an inclined surface 102a' inclined upward toward the outside in the radial direction. The inclined surface 102a 'has been subjected to a hydrophobic treatment. A water blocking portion 102b 'as an example of a standing wall portion is formed on a radially outer portion of the inclined surface 102a'.
Further, the seal 113 'as an example of the covering member of the second embodiment is arranged such that the position of the injection hole 113a' overlaps with the hydrophobic inclined portion 102 'in FIG. 22A viewed from above. The nozzles 22 to 24 of the second embodiment are arranged according to the position of the injection hole 113a '.
In the chip cassette S2 'of the second embodiment, nine spots 103 are arranged.

The chip cassette S2 'of the second embodiment is formed symmetrically in the front-rear and left-right directions except for the position of the injection hole 113a'. Here, in the chip cassette S2 'of the second embodiment, the length λ1 from the center position O to the inner end of the hydrophobic inclined portion 102' is 3.5 [mm] as an example in the left-right direction of FIG. 22B. Is set. Further, the length λ2 from the center position O to the water blocking portion 102b ′ of the hydrophobic inclined portion 102 ′ is set to 7 [mm]. Further, the length λ3 from the center position O to the inner wall portion 108 of the cassette retaining wall 104 is set to 10 [mm]. Further, the length λ4 from the center position O to the outer wall portion 108 of the cassette retaining wall 104 is set to 17 [mm]. In the vertical direction, the thickness λ5 of the substrate 101 is set to 1 [mm]. The height λ6 of the outer wall portion 102b ′ of the hydrophobic inclined portion 102 ′ is set to 1.5 [mm]. Further, the length λ7 from the lower portion of the substrate 101 to the upper surface 107b of the cassette retaining wall is set to 6 [mm]. The specific numerical values exemplified for the lengths λ1 to λ7 can be changed to arbitrary numerical values within a range in which the functions and effects of the present invention are exhibited.
In the inspection apparatus S1 according to the second embodiment, the setting unit 2 and the nozzles 22 to 24 are arranged according to the shape of the chip cassette S2 '.

(Operation of the Second Embodiment)
In the diagnostic system S of the second embodiment, the chip cassette S2 'of the second embodiment is used instead of the chip cassette S2 of the first embodiment. Also in the chip cassette S2 'of the second embodiment, the sample liquid L0 is injected from the injection hole 113a'. When the sample liquid L0 drops from the injection hole 113a ', it moves on the hydrophobic inclined portion 102' by the action of gravity. Therefore, the specimen liquid L0 moves to the reaction area A1 and can react with the spot 103.
Here, in the second embodiment, when there is a start input from the personal computer PC, the same reaction observation processing as in the first embodiment is executed. Therefore, as in the first embodiment, the rotation station 1 rotates to perform the drainage processing. Therefore, in the second embodiment, as in the first embodiment, the inspection accuracy is improved and the inspection time is shortened. In the chip cassette S2 'of the second embodiment, a closed chip cassette S2' having a water absorbing agent 112 and a seal 113 'is used. Therefore, as in the first embodiment, the operability is improved, and the safety is improved.

  Particularly, in the chip cassette S2 'of the second embodiment, the inclined surface 102a' is formed on the hydrophobic inclined portion 102 '. Therefore, even if the liquid attempts to move from the reaction area A1 on the hydrophobic inclined portion 102 'due to the centrifugal force, the liquid easily returns to the reaction area A1 by the action of gravity. Therefore, in the second embodiment, compared to the first embodiment, the liquid does not easily overflow from the reaction area A1, and the first rotation speed N1 can be increased. When the drainage processing is performed, the liquid in the reaction area A1 moves on the inclined surface 102a and moves to the drainage area A2. Then, when the liquid moves to the drainage area A2, it is blocked from returning to the reaction area A1 by the water blocking part 102b of the hydrophobic inclined part 102 '. Therefore, in the second embodiment, the return from the drainage area A2 to the reaction area A1 is more reliably prevented as compared with the case where the structure is not blocked by the wall-shaped member. In the second embodiment, the injection hole 113a 'does not overlap with the position of the spot 103 when viewed from above. Therefore, also in the second embodiment, similarly to the first embodiment, adverse effects on imaging are suppressed.

Next, a third embodiment of the present invention will be described. In the description of the third embodiment, the same reference numerals are given to components corresponding to the components of the first and second embodiments, and a detailed description thereof will be given. Is omitted.
This embodiment is different from the first embodiment in the following points, but is configured similarly to the first embodiment in other points.

(Description of diagnostic device S1 ')
(Description of rotating station 1 ')
FIG. 23 is an explanatory view of a main part of a diagnostic system according to Embodiment 3 of the present invention. FIG. 23A is an explanatory view of a rotating station, and FIG. FIG. 23C is an explanatory view of the coil spring on the rotation station of FIG. 23B.
In FIG. 23, a shaft support 71 is formed in the rotating station 1 'of the diagnostic apparatus S1' of the third embodiment in place of the setting section 2 of the first embodiment. A rotating shaft 73 extending upward is supported by the shaft support 71 via a bearing 72 as an example of a bearing member. At the upper end of the rotating shaft 73, a rotating unit 74, which is an example of a swing table and an example of a second rotating table, is fixedly supported. Therefore, the rotating part 74 is supported so as to be rotatable integrally with the rotating shaft 73 with respect to the rotating station 1 ′.

  In FIG. 23, a set portion 2 'similar to the set portion 2 of the first embodiment is formed above the rotating portion 74. Therefore, in the third embodiment, the chip cassette S2 is detachably supported by the set portion 2 'of the rotating portion 74 further rotatably supported by the rotating station 1'. In the third embodiment, when the chip cassette S2 is mounted on the setting section 2 ', the center of the reaction area A1 is arranged so as to correspond to the center of rotation of the rotating section. That is, in the third embodiment, the setting unit 2 ′ is configured so that the injection hole 113 a of the chip cassette S 2 coincides with the rotation center of the rotating unit 74.

  23A and 23C, a coil spring 76 as an example of an elastic member is fixed below the rotation shaft 73. The coil spring 76 is wound around the rotation shaft 73. That is, the coil spring 76 of the third embodiment is fixed in a state where the main body portion 76a is mounted on the spring fixing portion 73a. One end 76b of the coil spring 76 is supported by a first spring support 77 provided in the rotation station 1 '. Further, the other end 76c is supported by a second spring support 78 provided in the rotation station 1 '. Therefore, when the rotating part 74 rotates relative to the rotating station 1 ′ together with the rotating shaft 73, the positional relationship between the coil spring 76 and the spring supporting parts 77 and 78 changes, and the coil spring 76 is elastically deformed. Here, in the third embodiment, the coil spring 76 is configured such that the rotating portion 74 has a natural length at the reference position P11 shown in FIG. 23B.

  Therefore, when the rotating unit 74 relatively rotates from the reference position P11, the coil spring 76 is elastically deformed and the elastic force is increased regardless of the rotating direction of the rotating unit 74. Then, when the elastic force of the coil spring 76 increases and the rotation of the rotating unit 74 stops, the coil spring 76 starts elastic restoration. Therefore, the coil spring 76 is restored toward the natural-length reference position P11, and the rotating shaft 73 and the rotating unit 74 relatively rotate toward the reference position P11. Therefore, in the third embodiment, the rotating unit 74 is configured to be able to rotate forward and backward with respect to the rotating station 1 ′, and to be swingably rotatable based on the reference position P11 by the action of the coil spring 76.

In the third embodiment, the rotation angle of the rotation unit 74 with respect to the rotation station 1 'is regulated by the coil spring 76. That is, the elastic constant of the coil spring 73 is set such that the rotation angle of the rotating part 74 is within ± 90 degrees from the reference position P11. In the third embodiment, the elastic constant of the coil spring 76 is such that when the rotation station 1 'rotates at a high speed at the rotation speed N3, the rotation unit 74 can move to a position at a rotation angle of ± 90 degrees from the reference position P11. Is set.
The bearing 72, the rotating shaft 73, the coil spring 76, and the spring supporting portions 77 and 78 constitute a rotating mechanism 81 of a rotating unit as an example of the second rotating mechanism of the third embodiment.

In FIG. 23A, a temperature control mechanism 61 'is supported on the rotating station 1' of the third embodiment. That is, the micro heater 63 and the temperature sensor 64 are supported by the rotation station 1 'via the support member 62' corresponding to the lower part of the rotation part 74.
On the rotating shaft 3 'of the rotating station 1', a slip ring 91 as an example of an electric transmission member is supported between the rotating shaft 3 'and the rotating station 1'. The micro heater 63 and the temperature sensor 64 are electrically connected to the computer PC via the slip ring 91.
Third Embodiment The third embodiment includes a rotation station 1 ′, a rotation mechanism 4, a position detection mechanism 13, a nozzle device 21, a camera device 41, a temperature control mechanism 61 ′, a rotation unit 74, a rotation unit rotation mechanism 81, a slip ring 91, and the like. Of the diagnostic device S1 '.

(Operation of Third Embodiment)
In the diagnostic system S of the third embodiment, the diagnostic device S1 'of the third embodiment is used instead of the diagnostic device S1 of the first embodiment. That is, in the third embodiment, the chip cassette S2 is set in the setting section 2 'of the rotating section 74 supported on the rotating station 1'. Then, the sample liquid L0 is injected into the chip cassette S2, and the reaction observation process is performed as in the first embodiment. Therefore, also in the third embodiment, the inspection accuracy is improved and the inspection time is shortened, and the same operation and effect as those of the first embodiment are obtained. In particular, in the third embodiment, the rotating section 74 on which the set section 2 'is formed is rotatably supported with respect to the rotating station 1'. That is, when the rotating station 1 'rotates, the rotating unit 74 relatively rotates with respect to the rotating station 1' due to inertia or the like according to the rotating force of the rotating station 1 '.

  Here, in the first embodiment in which the setting unit 2 is fixed to the rotation station 1, even if the rotation station 1 is rotated at a non-discharge rotation speed, the liquids L0 to L2 in the chip cassette S2 of the setting unit 2 Even within the reaction area A1, there is a possibility that the reaction area A1 may be shifted outward in the direction in which the centrifugal force acts, and may be shifted to a part of the reaction area A1 in the circumferential direction. Therefore, in the reaction area A1, the spot 103 far from the rotation center is more likely to come into contact with a large amount of the sample liquid L0 or the antibody reagent L2 than the spot 103 near the rotation center. Therefore, there is a possibility that the reaction may vary between the spots 103.

  On the other hand, in the third embodiment, when the rotating station 1 'rotates, the set portion 2' rotates relatively to the rotating station 1 'due to inertia. In addition, the coil spring 76 elastically deforms in accordance with the relative rotation of the rotating unit 74, and rotates the rotating unit 74 toward the reference position P11 at the time of elastic restoration. Therefore, when the rotation station 1 'is rotated at a non-ejecting rotation speed, the setting unit 2' is relatively rotated so as to swing in the forward and reverse directions. Therefore, in the reaction area A1 of the chip cassette S2 according to the third embodiment, the position where the liquid is biased is easily changed as compared with the case where the setting section 2 'is fixed. Therefore, the liquids L0 to L3 in the reaction area A1 are suppressed from being partially offset in the circumferential direction. Therefore, in the third embodiment, the occurrence of a variation in the reaction between the spots 103 is suppressed, and the inspection accuracy is more easily improved than in the case where the setting unit 2 is fixed to the rotating station.

In the third embodiment, even when the rotation station 1 'is rotated at the rotation speed for discharging, the rotation unit 74 can be rotated relatively to the rotation station 1'. Therefore, the liquids L0 to L3 discharged from the areas A1 and A2 are easily dispersed and discharged in the circumferential direction from the areas A1 and A2. Therefore, compared with the case where the setting unit 2 is fixed to the rotating station, the discharged liquids L0 to L3 are easily absorbed directly by the water absorbing agent 112 in the entire circumferential direction.
In the third embodiment, when the rotating station 1 'stops at the positions P1 to P5 and inertia or the like does not act on the rotating portion 74, the coil spring 76 elastically restores to a natural length state. Therefore, the rotating section 74 is moved to and held at the reference position P11. Therefore, in the third embodiment, it is possible to return the rotating unit 74 to the reference position P11 without using an electric control member, for example, a motor. Therefore, for example, when the rotating station 1 'moves to the observation position P2, it is possible to image the spot 103 with the chip cassette S2 oriented in the same direction as in the first embodiment.

Next, a fourth embodiment of the present invention will be described. In the description of the fourth embodiment, the same reference numerals are given to the components corresponding to the components of the first embodiment, and the detailed description thereof will be omitted. I do.
This embodiment is different from the first embodiment in the following points, but is configured similarly to the first embodiment in other points.

FIG. 24 is an explanatory view of a main part of the diagnostic system according to the fourth embodiment of the present invention.
In FIG. 24, in the diagnostic system S of the fourth embodiment, a plate-like temperature control mechanism 201 is arranged on the lower surface of the chip cassette S2. The temperature control mechanism 201 has a sheet-like heating element 202 and an electrode unit (not shown) for supplying power to the heating element 202. As the heating element 202, a sandwich structure in which a transparent high-resistance conductive polymer is sandwiched between transparent polyimide films can be employed. Note that the heating element 202 can be observed from below by using a transparent structure. In addition, power is supplied to the temperature control mechanism 201 from a power supply (not shown), and the liquid in the chip cassette S2 can be heated.

  The temperature control mechanism is not limited to the illustrated temperature control mechanism 201, and any temperature control mechanism can be used. For example, a solution in the chip cassette S2 is heated by attaching a heating element to the bottom surface of an aluminum block corresponding to the size of the substrate 101 of the chip cassette S2 and bringing the heating aluminum block into contact with the bottom surface of the substrate 101, When heating is not performed, a configuration in which the heat-generating aluminum block is separated from the bottom surface of the substrate 101 can be considered. Therefore, the chip cassette S2 can be observed from below similarly to the configuration of the transparent heating element 202. In addition, the effect of the residual heat according to the heat capacity of the aluminum block can be used for assisting the heating.

Below the temperature control mechanism 201, a VCM (voice coil motor) 206 as an example of a vibration source for stirring the liquid is arranged. The VCM 206 is in point contact with the bottom surface of the temperature control mechanism 201, and is configured to be able to vibrate the chip cassette S2 vertically through the temperature control mechanism 201. In the fourth embodiment, the VCM 206 and the temperature control mechanism 201 are configured to be able to contact and separate from the chip cassette S2, and to contact the chip cassette S2 when stirring the liquid in the chip cassette S2, When the stirring is completed, the chip cassette S2 is separated from the chip cassette S2.
The VCM 206 and the temperature control mechanism 201 can be arranged corresponding to the zero point position P1, but are not limited to this, and can be arranged at other positions P2 to P5. It is also possible to arrange at a position different from the above.

  The VCM 206 according to the fourth embodiment stirs the liquid by periodically changing the frequency in a frequency region having a width including the resonance frequency of the secondary mode (bending and twisting mode) of the chip cassette S2. Therefore, in the fourth embodiment, the liquid inside the chip cassette S2 is not stirred by rotating the rotation station 1 as in the first embodiment, but is stirred using the VCM 206.

In FIG. 24, in the fourth embodiment, a reagent cartridge 211 is used in place of the nozzles 22 to 24 used in the first embodiment. The reagent cartridge 211 has a plurality of reagent containers 211a arranged side by side on a straight line, and each reagent container 211a stores (subdivides) a washing liquid, an antibody reagent, and a luminescent reagent by a single amount. . In the fourth embodiment, a supply port 212 is formed at the lower end of each reagent container 211a as an example of a liquid container. The upper surface of each reagent container 211a is closed by a seal 213 as an example of a sealing member.
The reagent cartridge 211 of the fourth embodiment is configured such that the supply port of any one of the reagent containers 211a is moved to a liquid supply position corresponding to the zero point position P1 of the first embodiment by a slider (not shown). The liquid supply position is not limited to the zero point position P1, but can be changed to an arbitrary position, and can be a position different from the VCM 206 or the like.

Further, a liquid supply mechanism 221 is disposed above the reagent container 211a. The liquid supply mechanism 221 has an injection needle 222 as an example of a supply member. A rubber hose 222a is connected to the injection needle 222, and the rubber hose 222a is connected to a pump (not shown). The injection needle 222 is supported by a slider 223, and the slider 223 is supported by an elevating mechanism 224 so as to be movable in the vertical direction.
Therefore, the liquid supply mechanism 221 can supply the liquid inside the reagent container 211a from the supply port 212 to the chip cassette S2 by injecting air from the pump in a state where the injection needle 222 is lowered and penetrates the seal 213. It is configured.

(Operation of Embodiment 4)
In the diagnostic system S according to the fourth embodiment having the above-described configuration, unlike the first embodiment, after the liquid in the chip cassette S2 is stirred by the VCM 206, the liquid is drained by the rotation of the rotation station 1. At this time, since the vibration applied from the VCM 206 periodically fluctuates in a frequency region including the resonance frequency of the secondary mode of the chip cassette S2, the vibration in the chip cassette S2 differs from that in another frequency band. The liquid is stirred for a short time.
In addition, by using the reagent cartridge 211 without using the nozzles 22 to 24, the number of nozzles and pumps can be reduced, the configuration can be simplified, the cost can be reduced, and when the amount is not subdivided into single doses. In comparison, weighing is unnecessary. In addition, after use, the reagent cartridge 211 may be discarded, and it has a disposable structure, which is safe for an operator or the like, and suppresses adverse effects of contamination or the like on a diagnosis result.

(Example of change)
As described above, the embodiments of the present invention have been described in detail. However, the present invention is not limited to the above embodiments, and various changes may be made within the scope of the present invention described in the appended claims. It is possible. Modifications (H01) to (H022) of the present invention are exemplified below.
(H01) In each of the above-described embodiments, the configuration in which an antigen is immobilized on the spot 103 and a diagnosis is performed using a sample liquid that may contain an antibody specific to the antigen has been described, but the present invention is not limited thereto. For example, instead of an antigen, a nucleic acid, protein, antibody, ligand, receptor, or the like is immobilized on the spot 103, and a test sample capable of interacting with the spot 103 is injected into the chip cassettes S2 and S2 ', and the diagnostic system S It is also possible to adopt a configuration for diagnosing with.
(H02) In each of the above embodiments, when the cleaning liquid L1 is supplied, a configuration in which the liquid is supplied to the extent that the liquid does not overflow from the reaction area A1 is desirable in that the absorption capacity of the water absorbing agent 112 may be small. When the absorption capacity of the water absorbing agent 112 is large, a configuration in which the liquid overflows from the reaction area A1 to the drainage area A2 when supplying the cleaning liquid L1 is also possible.

(H03) In each of the above embodiments, the configuration in which the rotation station 1 is rotated using the stepping motor 6 has been described as an example, but the invention is not limited to this. For example, a configuration is also possible in which a DC motor is used as a drive source, and the movement of the position of the rotating station 1 is controlled while detecting that the rotating station 1 moves to the positions P1 to P5 by a sensor or the like.
(H04) In each of the above embodiments, it is desirable that eight or more spots 103 are arranged, but eight or less spots may be used, and a configuration in which only one spot 103 is provided is also possible.
(H05) In each of the above embodiments, the direction in which the camera 43 of the diagnostic device S1 captures an image is from above, and the spot 103 is captured through the seal 113. However, the configuration is not limited thereto. For example, a configuration in which the substrate 101 is made of a transparent member, a camera is installed below, and an image is taken from below and the spot 103 is imaged over the substrate 101 is also possible.

(H06) In each of the above embodiments, in the chip cassettes S2 and S2 ', a configuration in which the reaction area A1, the drainage area A2, and the water absorbing agent 112 are arranged along the direction radially separated from the rotation center 3 is exemplified. However, the present invention is not limited to this. A chip cassette in which the reaction area A1, the drainage area A2, and the water absorbing agent 112 are arranged along the direction in which the centrifugal force acts can be provided.
(H07) In each of the above embodiments, the configuration in which the water absorbing agent 112 is provided is desirable, but the configuration is not limited to this. For example, a configuration in which a dent is formed in the drainage area A2 to hold drainage is also possible.
(H08) In each of the above embodiments, the chip cassettes S2 and S2 'are provided with the inner wall 108 and the holding space 109 holds the water absorbing agent 112. However, the present invention is not limited to this. For example, the absorber is made of a material whose shape and position are unlikely to change even when a centrifugal force acts thereon, and the inner wall 108 of the chip cassette S2 'is omitted to expose the absorber to the areas A1 and A2. A configuration in which they are arranged in a state is also possible.

(H09) In each of the above embodiments, it is necessary to supply the sample liquid L0 to the chip cassettes S2 and S2 'after setting the chip cassettes S2 and S2' to the chip cassettes S2 and S2 'when the sample liquid L0 is supplied or after the supply. , S2 'is desirable in that it is easy to stabilize the posture. However, the present invention is not limited to this, and a configuration is also possible in which the sample liquid L0 is supplied before the chip cassettes S2 and S2 'are set in the setting sections 2 and 2'.
(H010) In each of the above embodiments, in ST4 and ST5 of the flow chart of the reaction observation process, a configuration in which the same cleaning process is executed has been exemplified, but the present invention is not limited to this. For example, when the sample liquid L0 and the antibody reagent L2 have different ease of washing, the times T1 to T3 can be set to different times in ST4 and ST5. Similarly, in each process, even if the process name is the same, the time and the number of rotations can be set for each process according to the liquids L0 to L3.

(H011) In each of the above embodiments, the structure in which the sample liquid L0 and the antibody reagent L2 are washed with one type of washing liquid L1 has been exemplified, but the present invention is not limited thereto. For example, when cleaning the sample liquid L0, a cleaning liquid corresponding to the characteristics of the sample liquid L0 is supplied to the chip cassette S2 for cleaning. When cleaning the antibody reagent L2, a cleaning liquid corresponding to the characteristics of the antibody reagent L2 is used. Is supplied to the chip cassette S2 for cleaning. Further, when the washing is repeated a plurality of times, it is also possible to employ a configuration in which different washing liquids are used in accordance with the number of washings, such as using different washing liquids at the beginning and end. That is, the type of cleaning liquid is not limited to one type, and a plurality of types of cleaning liquids can be sequentially changed and used.
(H012) In each of the above embodiments, when supplying the cleaning liquid L0 and the reagents L2 and L3, three nozzles 22 to 24 are used and the rotating station 1 is moved to three corresponding positions P3 to P5. Although the configuration has been illustrated, the present invention is not limited to this. For example, when a plurality of types of cleaning liquids are added, or when a large number of reagents are required for the inspection, a configuration in which the rotating station 1 is moved to four or more corresponding positions using four or more nozzles is also available. It is possible.

(H013) In each of the above-described embodiments, the configuration of the personal computer PC is a so-called tablet personal computer having the touch panel H2. However, the configuration is not limited thereto, and a configuration using a desktop personal computer or a notebook personal computer is also possible. Further, the configuration is not limited to the personal computer PC, and a configuration in which the information processing device is incorporated in the inspection device S1 is also possible. Further, the configuration in which the processing is performed by one information processing apparatus has been described, but a configuration having a control unit for each apparatus is also possible. For example, the temperature control device 61 may be electrically disconnected from the computer main body H1, provided with a control unit independent of the personal computer PC, and configured to operate the temperature control device independently of the personal computer PC.

(H014) In each of the above embodiments, when draining the cleaning liquid L1, it is desirable to perform low-speed rotation, but this is not a limitation, and a configuration in which low-speed rotation is omitted is also possible.
(H015) In each of the above embodiments, when the luminescent reagent is drained, the configuration in which the medium-speed rotation is omitted is exemplified. However, the present invention is not limited to this, and the medium-speed rotation may be performed.
(H016) In each of the above embodiments, the shape of the substrate 101 of the chip cassettes S2 and S2 'is exemplified as a square, but any shape such as a rectangle or an ellipse is possible. In addition, the configuration in which the reaction area A1 is configured to be circular has been illustrated, but shapes such as an ellipse, a rectangle, and a square are also possible.
(H017) In each of the above embodiments, a disk-shaped configuration such as the rotary station 1 is preferable as the rotary table in that the center of gravity during rotation is easily stabilized, but is not limited thereto. For example, a rotary table composed of a rod member supported by the rotating shaft 3 and extending radially outward and a set portion 2 provided at a radially outer end of the rod member is also possible. It is. That is, the rotary table is not limited to a disk shape but may be any shape as long as the chip cassettes S2 and S2 'are supported and rotatable.
(H018) In the above embodiments, the specific numerical values exemplified can be changed to any numerical values within a range in which the functions and effects of the present invention are exhibited.

(H019) In the first and second embodiments, the configuration in which the micro heater 63 of the temperature control mechanism 61 is fixedly arranged below the rotating station 1 is exemplified. However, the present invention is not limited to this. A configuration in which the heater 63 is incorporated in the rotation station 1 is also possible. In the third embodiment, a configuration in which the micro heater 63 is incorporated in the rotating unit 74 is also possible.
(H020) In each of the above embodiments, the configuration in which the diagnostic system S has one personal computer PC is illustrated, but the configuration is not limited thereto, and the diagnostic system S may have a configuration having a plurality of information processing devices. That is, the configuration for transmitting and receiving information to and from another information processing device using the communication function of the computer main body H1 of the personal computer PC can be applied to the diagnostic system S. For example, a configuration is possible in which the computer main body H1 transmits a measurement result to a remote information processing device via the Internet as an example of a communication line. This makes it possible, for example, to seek a second opinion or the like from another specialist at a remote location. In addition, it is possible to connect a plurality of inspection apparatuses S1 and a personal computer PC via a LAN: Local Area Network as an example of a communication line, and to integrate and use the measurement results inspected by each inspection apparatus S1. . Therefore, for example, it is also possible to statistically process the measurement result and correct the analysis method for the image data.

(H021) In each of the above embodiments, in the diagnosis system S, a configuration in which one personal computer PC executes the reaction observation process has been described as an example. However, the present invention is not limited to this. It is possible. For example, the function of the image analysis means C11 is provided not in the personal computer PC for controlling the inspection apparatuses S1 and S1 'but in an information processing apparatus installed in a remote place. Further, the image data captured by the inspection apparatuses S1 and S1 'is transmitted from the personal computer PC to the information processing apparatus at the remote place. Then, the information processing apparatus at the remote place performs analysis processing of the received image data, and transmits the analyzed measurement result to the personal computer PC. The personal computer PC may display the received measurement result on the display panel H2.
(H022) In each of the above embodiments, the configuration in which the camera 43 reads a barcode has been described as an example, but the present invention is not limited to this. For example, a bar code reader as an example of an identifier reading member is connected to a personal computer PC connected to the diagnostic devices S1 and S1 ', and the bar code reader reads bar codes of the chip cassettes S2 and S2'. It is also possible.

  The test system, test method and test substrate according to the present invention, for example, using a test substrate in which antigens of different types of biomolecules are immobilized as a plurality of spots, a sample to be analyzed, with a small sample amount, at high speed, It is inexpensive, safe and easy to handle, and can analyze many items at the same time. With a compact installation area, it can be applied to point-of-care test analysis for use in clinical sites and the like.

1, 1 '... turntable,
3,3 '... rotation center,
4 ... Rotation drive mechanism,
22 cleaning liquid supply section,
43 ... observation members,
74 ... second turntable,
102, 102 '... separation part,
102a ': inclined surface,
102b ': wall,
103 ... Spot,
112 ... absorber,
113, 113 '... covering member,
113a, 113a '... supply port,
A1: accommodation unit,
A2: drainage part,
C2: means for controlling the drainage of the cleaning liquid,
L0 ... test sample, liquid,
L1 ... cleaning liquid, liquid,
N1: rotation speed for non-discharge,
N2, N3 ... number of revolutions for discharge,
S: Inspection system,
S1, S1 '... inspection device,
S2, S2 '... inspection base.

Claims (9)

A turntable that can rotate around the center of rotation,
A test base supported by the turntable, a storage part capable of storing a liquid test sample, and the detection target disposed when the test sample contains a component to be detected in the storage part. A spot on which a component that reacts with the component is fixed, a drain portion disposed radially outside of the storage portion with respect to the rotation center, and separation for separating the storage portion and the drain portion. A test substrate having:
A rotation drive mechanism for rotating the turntable,
A cleaning liquid supply unit that supplies a cleaning liquid to the storage unit of the test base,
When the cleaning liquid is supplied via the rotation driving mechanism, the liquid containing at least one of the cleaning liquid and the test sample moves from the storage section to the drainage section. die rotate, and control means drainage Before moving the liquid to the drainage unit,
When the liquid is drained from the container to the drainage unit by centrifugal force, an observation member that observes a spot in the container,
An inspection system comprising: Absorber that absorbs the liquid that has moved into the drainage unit is disposed in the drainage unit,
The inspection system according to claim 1, further comprising: A testing base to which the cleaning liquid is supplied from above in the direction of gravity of the storage section, the transparent coating member covering the storage section and the drain section from above, a supply port in which the test sample and the cleaning fluid and is formed in a member liquid is supplied, and a non-overlapping and wherein provided at a position corresponding to the accommodating part and the supply port to the spot when viewed from above The test substrate having:
The observation member disposed above the turntable,
The inspection system according to claim 1 or 2, further comprising: An inclined surface inclined upward in the direction of gravity from the storage portion toward the drainage portion, and a wall portion extending from the end of the inclined surface toward the drainage portion toward the bottom surface of the storage portion , Said separating unit having
The inspection system according to any one of claims 1 to 3, further comprising: When the cleaning liquid is supplied, said the turntable is rotated at a rotational speed for non-discharge of the liquid acts residence capable centrifugal force to the receptacle, after in flowing the liquid in said containing portion control means before Sharing, ABS solution for rotating the turntable with the rotational speed for the discharge of the centrifugal force the liquid to move to the drainage portion from the receiving portion is applied,
The inspection system according to any one of claims 1 to 4, further comprising: A second turntable that supports the inspection base and is rotatably supported by the turntable;
The inspection system according to any one of claims 1 to 5, further comprising: Vibration source in contact with the test substrate, applying vibration to agitate said liquid in said containing portion to the test substrate,
The inspection system according to any one of claims 1 to 4, further comprising: A cleaning liquid supply unit and a reagent supply unit configured by a cartridge having a plurality of liquid containers in which the cleaning liquid or the reagent liquid supplied to the storage unit of the test substrate is subdivided and stored,
The inspection system according to any one of claims 1 to 7, further comprising: A storage portion capable of storing a liquid test sample, and a spot in which a component that is arranged in the storage portion and reacts with the detection target component when the test sample contains the detection target component is fixed, a drainage portion disposed adjacent to the receiving portion, and a separation unit for separating the said housing portion drainage unit, the test査基body that have a, rotatable turntable around a rotation center In response, a step of arranging the liquid drain portion radially outward with respect to the rotation center with respect to the storage portion and supporting the drainage portion on the turntable,
Supplying a test sample to the test base;
Supplying a cleaning liquid to the storage section of the test substrate,
When the cleaning liquid is supplied, the liquid including at least one of the cleaning liquid and the test sample is rotated at a rotation speed at which a centrifugal force is applied to move the liquid from the storage unit to the drainage unit. A draining step of moving a liquid to the draining section,
A step of observing a spot in the storage section when the liquid is drained from the storage section;
An inspection method characterized by performing: