JP6137106B2 - Inspection chip and inspection system - Google Patents

Description

  The present invention relates to a test chip in which a sample or a reagent is quantified in a quantification unit, and a test system that applies a centrifugal force to the test chip to test a sample placed on the test chip.

  2. Description of the Related Art Conventionally, there is known a test chip that includes a quantification unit that quantifies a specimen or a reagent, and that quantifies the injected sample or reagent by being moved to the quantification unit by centrifugal force. For example, the test chip described in Patent Document 1 includes a sample holding unit, a sample supply unit, and a sample quantification unit. A sample is injected into the sample holder. The sample supply unit supplies the sample flowing from the sample holding unit to the sample determination unit via the sample guide unit. The sample is quantified in the sample quantification unit. The sample quantification unit includes a first end connected to the first passage through which the quantified sample flows, and a second end connected to the second passage guiding the excess sample to the sample surplus portion. The sample guide unit is a flow path for guiding the sample from the sample supply unit to the sample holding unit, and the outlet of the flow channel faces between the first end and the second end of the sample determination unit.

JP 2014-81247 A

  In the test chip described in Patent Document 1, there is a possibility that the sample injected from the sample guide unit may hit the second end of the sample determination unit. In this case, the air in the sample quantification unit does not escape outside the quantification unit due to the sample flowing into the quantification unit in contact with the second end, and remains in the quantification unit. As a result, there is a possibility that the quantitative accuracy is lowered.

  The objective of this invention is providing the test | inspection chip and test | inspection system which improve the fixed_quantity | quantitative_assay precision of a specimen or a reagent by reducing possibility that air will remain in a fixed_quantity | quantitative_assay part.

The test chip according to the first aspect of the present invention includes an injection part formed from a recess provided in the upper side part of a plate member having a predetermined thickness and opened in the injection port direction, into which a specimen or a reagent is injected, and below the injection part quantitative portion to which the specimen or the reagent is formed from the opened recess is quantified toward the upper part in, Oite between the injection part and the quantification part, in a direction crossing the opening direction of the injection unit A holding portion that is formed from an open recess and holds the specimen or the reagent, a first wall surface that is a wall surface of the holding portion that extends in the holding portion toward the quantitation portion, and downstream of the quantitation portion Formed in the mixing part direction and the upper side part from the mixing part into which the sample or the reagent quantified by the quantification part is formed and the first end part which is one end part of the quantification part on the mixing part side To the quantitative unit The upper portion of the stomach and the first guide unit that moves said analyte or said reagent is quantified, and the mixing section of the quantifying section to the mixing section from the second end portion is an end portion opposite to the opposite direction and And a second guide part in which the sample or the reagent overflowing from the quantification part moves, and a predetermined injection amount of the reagent into the injection part, or The direction of communication between the injection part and the holding part, in which the outflow amount of the specimen separated by the separation part for separating the specimen and flowing out from the separation part is a direction intersecting the opening direction of the injection part Is formed by a first virtual surface extending in the direction of the angle α from the tip of the first wall surface and a wall surface that is connected to the first wall surface and forms the holding portion. When the volumes are equal, the angle α is such that the first wall surface is Larger than an angle β formed with respect to a direction parallel to the direction, and the reagent or the specimen flows out from the holding unit toward the quantification unit through the first tip of the holding unit to the first virtual surface. A test chip, wherein a first imaginary line that is a vertical straight line passes through the first end portion side from the second end portion.

  Since the angle α is larger than the angle β, a predetermined amount of reagent to be injected into the injection part and the separated specimen flowing out from the separation part are held in the holding part. When the predetermined injection amount of the reagent or the separated sample flowing out from the separation unit flows into the quantification unit, the reagent or the sample flows along the first virtual line. Since the first imaginary line passes from the second end to the first end, the predetermined amount of the reagent flows into the quantification unit without hitting the second end. Therefore, when a predetermined injection amount of reagent flows, a gap is formed between the second end and the sample flowing into the quantitative unit. The air in the quantitative unit can escape outside the quantitative unit through this gap. The same applies to the separated specimen flowing out from the separation section. Therefore, the possibility of air remaining on the second end side of the quantification unit can be reduced, and the quantification accuracy of the specimen or reagent can be improved.

As the quantification section, and the reagent quantitation channel is the channel having a reagent quantification section for quantifying the reagent, as the quantification section, the specimen quantitation is the channel having a sample quantifying section for quantifying the sample a test chip Ru comprising a flow path, respectively, quantitative amount of the reagent quantitation section, more than quantitative amount of the analyte quantification section, before Symbol solution quantitative flow path, said first imaginary line is the It passes through the reagent quantitation section, in the prior SL analyte quantitative flow path, said first virtual line than the first end passes through the first guide portion, and to form the first guide portion and the second Of the angle formed by the first guide wall connected to the one end and the first imaginary line, the angle in the first guide may be less than 90 degrees.

  In this case, the quantitative amount of the reagent quantitative unit is larger than the quantitative amount of the sample quantitative unit. That is, the injection amount into the reagent quantification unit is larger than the injection amount into the sample quantification unit, and it is necessary to prevent the reagent injected into the reagent quantification unit from hitting the wall surface of the first guide unit and flowing downstream. In the test chip, when the reagent flows into the reagent quantitative unit, the flow of the reagent follows the first imaginary line. Since the first virtual line passes through the reagent quantification unit, the flow of the reagent flows into the quantification unit without hitting the wall of the second end and the first guide unit. In addition, since the quantitative amount of the sample quantification unit is smaller than the quantitative amount of the reagent quantification unit, the sample bounces and flows out of the quantification unit, leading to insufficient quantification. In the test chip, when the sample flows into the sample quantification unit, the flow of the sample follows the first imaginary line. Since the first imaginary line passes through the first guide part side of the first end of the specimen quantification part and the angle formed by the first guide wall surface and the first imaginary line is less than 90 degrees, the specimen is the second one. It flows into the sample quantification part from the first end part side without hitting the end part. Therefore, after the reagent or sample is filled in the quantitative unit, the reagent or sample overflows from the second end. Therefore, the possibility of air remaining on the second end side of the quantification unit can be reduced, and the quantification accuracy of the specimen or reagent can be improved.

  When the quantification unit is a sample quantification unit that quantifies the sample, an angle β1 formed by the first wall surface with respect to a direction parallel to the communication direction is determined by the reagent quantification unit in which the quantification unit quantifies the reagent. In this case, the ratio of the quantitative amount of the specimen quantification part to the effluent quantity of the specimen after separation flowing out from the separation part is smaller than an angle β2 formed by the first wall surface in a direction parallel to the communication direction, The ratio of the fixed amount of the reagent quantification unit to the predetermined injection amount of the reagent to the injection unit may be larger.

  In order to improve the quantification accuracy of the sample in the sample quantification unit, it is necessary to inject the sample into the sample quantification unit more reliably. For this purpose, it is necessary that the direction of the centrifugal force applied to the test chip is perpendicular to the first wall surface after injecting a sample surplus than the sample quantitative amount in the sample quantitative unit into the sample quantitative unit. That is, the interval between the timing when the excess sample flows out from the second end portion of the sample quantification unit and the timing when the injection of the sample into the sample quantification unit ends becomes longer because the direction of the centrifugal force is perpendicular to the first wall surface. There is a need. For this purpose, it is necessary to increase the difference between the angle α at which the specimen held by the holding part flows and the angle β1 that the first wall surface forms with respect to the direction parallel to the communication direction. In order to increase the angle α, it is necessary to increase the amount injected into the specimen quantification unit. The amount injected into the sample quantification unit is the amount of the sample after being separated by the separation unit. Therefore, if the amount injected into the sample quantification unit is increased, it is necessary to increase the amount of the sample after separation, and it is necessary to increase the amount of the sample before separation, and the outer shape of the test chip is increased. On the other hand, when the first wall surface angle β1 is reduced without increasing the angle α, there is no problem as described above, and the timing at which an excess sample flows out from the second end of the sample quantification unit; It is possible to increase the interval between the timing when the direction of the centrifugal force becomes perpendicular to the first wall surface. In addition, the ratio of the quantitative amount of the sample quantitative unit to the flow rate of the separated sample flowing out from the separation unit can be larger than the ratio of the quantitative amount of the reagent quantitative unit to the predetermined injection amount of the reagent to the injection unit. For example, since the amount of the sample after separation flowing into the second guide portion is wasted, it is not necessary to increase the size of the injection portion into which the sample is injected. Therefore, it is possible to reduce the necessity of increasing the outer shape of the inspection chip.

A test system according to a second aspect of the present invention is the test chip according to any one of the above, the test chip is held and revolved to apply centrifugal force to the test chip, and the test chip is rotated. An inspection system comprising an inspection device that changes the direction in which the centrifugal force is applied, wherein the inspection chip removes the sample from the holding unit when the quantification unit is a sample quantification unit that quantifies the sample. In the case where the opening width of the sample guide section for guiding to the sample quantifying section is narrower than the opening width of the sample quantifying section, and the quantifying section is a reagent quantifying section for quantifying the reagent, the reagent is transferred from the holding section to the reagent quantifying section. An opening width of a reagent guide section that guides to a reagent quantitative section is formed wider than an opening width of the specimen guide section, and the inspection apparatus includes a test chip holding section that holds the test chip, and the test chip holding section. Centered on the first axis A first rotating device that revolves and applies a centrifugal force to the inspection chip; and the centrifugal force that is applied to the inspection chip by rotating the inspection chip holding portion around a second axis that intersects the first axis. A second rotation device that changes the direction of the first rotation device, and a control device that controls the first rotation device and the second rotation device. The storage device of the control device includes a viscosity μ of the sample, a sample guide unit Connected to the channel length L, the channel cross-sectional area S of the sample guide unit, the mass m of the sample injected into the sample determination unit, the gravitational acceleration g, and the second end of the determination unit, An acute angle θ formed by the inclined surfaces constituting the two guide portions with respect to the direction parallel to the communication direction, the opening width d2 of the first end portion and the second end portion of the quantitative portion, and the depth of the quantitative portion W, the surface tension T of the specimen, and the contact angle δ of the specimen liquid And when the sample is injected into the sample quantification unit, the control device controls the second rotation device to perform a first centrifugal direction that is a direction perpendicular to the first virtual plane, The test chip is centered on the second axis so that the centrifugal force is applied in the order of the second centrifugal direction that is perpendicular to the first wall surface and the third centrifugal direction that is perpendicular to the quantitative surface. Rotation angle changing rotation is executed, and a time t in which the direction in which the centrifugal force is applied from the first centrifugal direction to the second centrifugal direction, which is an injection time related to the injection of the sample into the sample quantification unit, is t. In this case, the magnitude of the first centrifugal force applied in the first centrifugal direction and the second centrifugal direction is larger than 32 × μ × L ² / (s × t × m × g). , Controlling the revolution speed of the inspection chip by the first rotating device, The first rotational force F1 applied in the third centrifugal direction is greater than (2 × (d2 + w) × T × cos δ × cos θ / cos (90−θ)) + 1. The revolution speed of the inspection chip by the apparatus is controlled.

  In this case, the opening width of the sample guide unit is narrower than the opening width of the sample determination unit and smaller than the opening width of the reagent guide unit. Therefore, the flow path resistance of the sample guide unit is the flow path of the reagent guide unit. Greater than resistance. Therefore, it is difficult for the sample to flow due to the flow path resistance of the sample guide unit, and the sample is not filled in the sample determination unit before the second centrifugal force is applied in the third centrifugal direction, and the sample is applied when the second centrifugal force is applied. Since the second centrifugal force is applied in a direction perpendicular to the quantifying surface of the quantifying unit, there is a possibility that the sample directly hits the quantifying surface and the liquid surface is recessed, resulting in a shortage of the quantifying amount. When the specimen is injected into the specimen quantification unit, the first centrifugal force is applied in the first centrifugal direction, the first centrifugal force is then applied in the second centrifugal direction, and the second centrifugal force is further applied in the third centrifugal direction. Is applied. Therefore, even when the flow path resistance is large, before the second centrifugal force acting in the third centrifugal direction is applied, the specimen quantification section is filled with the specimen, and the specimen is moved from the second end to the second guide section. You can start the spill. Therefore, in order to regulate the inflow amount of the sample to the sample quantification part, the liquid width of the inflow liquid can be limited by both the resistance of the first wall part and the guide part flow path, and the liquid at the second end part. Can reduce the possibility of air remaining on the second end side of the specimen quantification unit, and improve the quantification accuracy of the specimen or reagent. Furthermore, since the sample quantitative unit has a small quantitative amount, the sectional area of the quantitative surface is small, and when a centrifugal force is applied perpendicular to the quantitative surface, the holding force held by the quantitative surface is weak. The sample tends to flow out. Therefore, it is possible to hold the specimen on the quantitative surface by applying the third centrifugal force related to the sectional area of the quantitative surface in order to hold the specimen on the quantitative surface without flowing out of the specimen to the second guide side. it can.

  The storage device is connected to the second end of the quantification unit, and an acute angle θ ′ formed with respect to a direction parallel to the communication direction by an inclined surface constituting the second guide unit, the quantification unit The opening width d2 ′ between the first end portion and the second end portion, the depth w ′ of the quantifying portion, the surface tension T ′ of the reagent, and the contact angle δ ′ of the reagent solution are stored in advance. When the reagent is injected into the reagent quantification unit, the control device causes a third centrifugal force different from the first centrifugal force to act in the first centrifugal direction and the second centrifugal direction, and The first rotating device and the second rotating device are controlled so that the second centrifugal force larger than the third centrifugal force is applied to the test chip in the three centrifugal directions, and the second centrifugal force is (2 × (D2 ′ + w ′) × T ′ × cos δ ′ × cos θ ′ / cos (90−θ ′)) + 1 To so that may be controlled revolution speed of the inspection chip according to the first rotary device.

  In the above case, the opening width of the reagent guide portion is formed wider than the opening width of the sample guide portion. Therefore, when the reagent passes through the reagent guide unit, it is not necessary to apply a centrifugal force that overcomes the channel resistance from the narrow channel as in the case where the sample passes through the sample guide unit. Further, since the second centrifugal force is applied so as to be larger than (2 × (d2 ′ + w ′) × T ′ × cosδ ′ × cosθ ′ / cos (90−θ ′)) + 1, The reagent can be injected into the reagent quantification unit without leaving the reagent on the first wall surface.

（式１）
になるようにし、
前記検体定量部へ前記検体が注入される場合には、
時間ｔ１が

（式２）
になるように前記制御装置が前記第一回転装置及び前記第二回転装置を制御するようにしてもよい。 The length of the second imaginary line extending from the portion where the second imaginary plane parallel to the first imaginary plane is in contact with the bottom of the reagent quantification unit to the second end is Lm ′, and is parallel to the first imaginary plane. The length of the second imaginary line extending from the portion where the second virtual surface is in contact with the bottom of the sample quantification unit to the end of the second sample quantification unit is Lm, and the first centrifugal force is applied in the first centrifugal direction. When the centrifugal force applied to the test chip during the time t1 from when the first centrifugal force is applied to when the first centrifugal force is applied in the second centrifugal direction is F1, When reagents are injected,
Time t1 is

(Formula 1)
So that
When the sample is injected into the sample quantification unit,
Time t1 is

(Formula 2)
The controller may control the first rotating device and the second rotating device.

  In this case, the opening area of the reagent guide part is formed wider than the opening area of the specimen guide part, but since the time t1 is in the relationship of (Equation 1), Reagent injection is performed slowly. Therefore, the reagent injected into the reagent quantitative unit does not flow from the reagent guide unit at a stretch. Therefore, the liquid width of the reagent to be injected can be narrowed down. Furthermore, it is possible to reduce the possibility that the reagent injected into the second end of the reagent quantification unit will hit, and to reduce the possibility that air will remain on the second end side, thereby improving the quantification accuracy of the reagent. In addition, the opening area of the sample guide part is narrower than the opening area of the sample quantification part and smaller than the opening area of the reagent guide part, but the time t1 has a relationship of (Equation 2). Therefore, before the second centrifugal force acts in the third centrifugal direction by quickly rotating the test chip, the sample quantification part is filled with the specimen, and the specimen flows out from the second end to the second guide part side. You can make a start. Therefore, the possibility of air remaining on the second end side of the sample quantification unit can be reduced, and the quantification accuracy of the sample or reagent can be improved.

It is a figure which shows the structure of the test | inspection system 3 containing the test | inspection apparatus 1 and the control apparatus 90. FIG. It is a front view of the test | inspection chip 2. FIG. It is a rear view of the test | inspection chip 2. FIG. It is the elements on larger scale of the front of the test | inspection chip. It is the elements on larger scale of the front of the test | inspection chip. It is a flowchart of a centrifugation process. It is a state transition diagram of the test | inspection chip 2 in a centrifugation process. FIG. 8 is a state transition diagram of the test chip 2 continued from FIG. 7. FIG. 9 is a state transition diagram of the test chip 2 continued from FIG. 8. FIG. 10 is a state transition diagram of the test chip 2 continued from FIG. 9. It is the elements on larger scale of the front of the test | inspection chip. It is the elements on larger scale of the front of the test | inspection chip.

  DESCRIPTION OF EMBODIMENTS Embodiments embodying the present invention will be described with reference to the drawings. FIG. 1 shows a plane of the inspection apparatus 1 constituting the inspection system 3 and functional blocks inside the control apparatus 90.

<1. Schematic structure of inspection system 3>
A schematic structure of the inspection system 3 will be described with reference to FIG. The inspection system 3 of the present embodiment includes an inspection chip 2 that can store a sample and a reagent that are liquids, and an inspection apparatus 1 that performs an inspection using the inspection chip 2. When the inspection device 1 rotates the inspection chip 2 around the vertical axis A <b> 1 separated from the inspection chip 2, centrifugal force acts on the inspection chip 2. When the inspection apparatus 1 rotates the inspection chip 2 around the horizontal axis A2, the centrifugal direction, which is the direction of the centrifugal force acting on the inspection chip 2, is switched. In addition, since the inspection system 3 and the inspection apparatus 1 of this embodiment have a known structure as described in JP 2012-78107 A, in the following description, an outline of the structure of the inspection apparatus 1 will be described. To do.

<2. Structure of the inspection apparatus 1>
The structure of the inspection apparatus 1 will be described with reference to FIG. In the following description, the upper side, the lower side, the right side, the left side, the front side of the paper surface, and the rear side of the paper surface in FIG. . In the present embodiment, the direction of the vertical axis A1 is the vertical direction of the inspection apparatus 1, and the direction of the horizontal axis A2 is the direction of the speed when the inspection chip 2 is rotated about the vertical axis A1. FIG. 1 shows a state where the top plate of the upper housing 30 of the inspection apparatus 1 is removed.

  As shown in FIG. 1, the inspection apparatus 1 includes an upper housing 30, a lower housing 31, an upper plate 32, a turntable 33, an angle changing mechanism 34, and a control device 90. The turntable 33 is a disk rotatably provided on the upper side of an upper plate 32 described later. The inspection chip 2 is held above the turntable 33. The angle changing mechanism 34 is a drive mechanism provided on the turntable 33. The angle changing mechanism 34 rotates the inspection chip 2 around the horizontal axis A2. The upper housing 30 is fixed to an upper plate 32 described later, and a measurement unit 7 that performs optical measurement on the inspection chip 2 is provided inside. The control device 90 is a controller that controls various processes of the inspection device 1.

  A schematic structure of the lower housing 31 will be described. The lower housing 31 has a box-shaped frame structure in which frame members are combined. An upper plate 32 that is a rectangular plate material is provided on the upper surface of the lower housing 31. A drive mechanism that rotates the turntable 33 around the vertical axis A1 is provided in the lower housing 31 as follows.

  A spindle motor 35 that supplies a driving force for rotating the turntable 33 is installed on the left side in the lower housing 31. A shaft 36 of the main shaft motor 35 protrudes upward, and a pulley 37 is fixed. A vertical main shaft 57 extending upward from the inside of the lower housing 31 is provided at the center of the lower housing 31. The main shaft 57 passes through the upper plate 32 and protrudes above the lower housing 31. The upper end portion of the main shaft 57 is connected to the center portion of the turntable 33.

  The main shaft 57 is rotatably held by a support member (not shown) provided immediately below the upper plate 32. A pulley 38 is fixed to the main shaft 57 below the support member. A belt 39 is stretched over the pulley 37 and the pulley 38. When the main shaft motor 35 rotates the shaft 36, the driving force is transmitted to the main shaft 57 via the pulley 37, the belt 39, and the pulley 38. At this time, the turntable 33 rotates around the main shaft 57 in conjunction with the rotation of the main shaft 57.

  A guide rail (not shown) extending in the vertical direction inside the lower housing 31 is provided on the right side in the lower housing 31. A T-shaped plate (not shown) is movable in the vertical direction in the lower housing 31 along the guide rail.

  The aforementioned main shaft 57 is a cylindrical body having a hollow inside. An inner shaft (not shown) is a shaft that can move in the vertical direction inside the main shaft 57. The upper end portion of the inner shaft passes through the main shaft 57 and is connected to the rack gear 43. A bearing (not shown) is provided at the left end of the T-shaped plate. Inside the bearing, the lower end portion of the inner shaft is rotatably held.

  A stepping motor 51 for moving the T-shaped plate up and down is fixed in front of the T-shaped plate. The shaft 58 of the stepping motor 51 protrudes rearward, that is, downward in FIG. A disc-shaped cam plate (not shown) is fixed to the tip of the shaft 58. A cylindrical projection (not shown) is provided on the rear surface of the cam plate. The tip of the protrusion is inserted into a groove (not shown). The protrusion can slide in the groove. When the stepping motor 51 rotates the shaft 58, the protrusion moves up and down in conjunction with the rotation of the cam plate. At this time, the T-shaped plate moves up and down along the guide rail in conjunction with the protrusion inserted in the groove.

  The detailed structure of the angle changing mechanism 34 will be described. The angle changing mechanism 34 has a pair of L-shaped plates 60 fixed to the upper surface of the turntable 33. Each L-shaped plate 60 extends upward from a base portion fixed in the vicinity of the center of the turntable 33, and its upper end portion extends outward in the radial direction of the turntable 33. A rack gear 43 (not shown) fixed to the inner shaft is provided between the pair of L-shaped plates 60. The rack gear 43 is a metal plate-like member that is long in the vertical direction, and gears are respectively carved on both end faces.

  On the front end side in the extending direction of each L-shaped plate 60, a horizontal support shaft 46 having a gear 45 is rotatably supported. The support shaft 46 is fixed to the inspection chip 2 through a mounting holder 61. For this reason, the inspection chip 2 also rotates around the support shaft 46 in conjunction with the rotation of the gear 45. Between the gear 45 and the rack gear 43, a pinion gear 44 supported by an L-shaped plate 60 so as to be rotatable about a horizontal axis (not shown) is interposed. The pinion gear 44 meshes with the gear 45 and the rack gear 43, respectively. In conjunction with the vertical movement of the rack gear 43, the pinion gear 44 and the gear 45 are driven to rotate, and the inspection chip 2 is rotated about the support shaft 46.

  In the present embodiment, as the main shaft motor 35 rotationally drives the turntable 33, the inspection chip 2 rotates around the main shaft 57 that is a vertical axis, and a centrifugal force acts on the inspection chip 2. The rotation around the vertical axis A1 of the inspection chip 2 is referred to as revolution. On the other hand, as the stepping motor 51 moves the inner shaft up and down, the inspection chip 2 rotates about the support shaft 46 which is a horizontal axis, and the direction of the centrifugal force acting on the inspection chip 2 changes relatively. The rotation around the horizontal axis A2 of the inspection chip 2 is called autorotation.

  In a state where the T-shaped plate is lowered to the lowermost end of the movable range, the rack gear 43 is also lowered to the lowermost end of the movable range. At this time, the inspection chip 2 is in a steady state where the rotation angle is 0 degree. Further, in the state where the T-shaped plate is raised to the uppermost end of the movable range, the rack gear 43 is also raised to the uppermost end of the movable range. At this time, the test | inspection chip 2 will be in the state rotated 180 degree | times centering on the horizontal axis line A2 from the steady state. That is, in this embodiment, the angle width that the test chip 2 can rotate is the rotation angle of 0 degrees to 180 degrees.

  The detailed structure of the upper housing 30 will be described. As shown in FIG. 1, the upper housing 30 has a box-like frame structure in which frame members are combined, and is installed on the upper left side of the upper plate 32. More specifically, the upper housing 30 is provided outside the range in which the inspection chip 2 is rotated as viewed from the main shaft 57 at the rotation center of the turntable 33.

  The measurement unit 7 provided inside the upper housing 30 includes a light source 71 that emits measurement light, and an optical sensor 72 that detects the measurement light emitted from the light source 71. The light source 71 and the optical sensor 72 are disposed on both the front and rear sides of the turntable 33 outside the rotation range of the inspection chip 2. In the present embodiment, the position on the left side of the main shaft 57 in the reciprocable range of the inspection chip 2 is the measurement position at which the inspection chip 2 is irradiated with the measurement light. When the inspection chip 2 is at the measurement position, the measurement light connecting the light source 71 and the optical sensor 72 intersects the front surface and the rear surface of the inspection chip 2 substantially perpendicularly.

<3. Electrical configuration of control device 90>
The electrical configuration of the control device 90 will be described with reference to FIG. The control device 90 includes a CPU 91 that performs main control of the inspection device 1, a RAM 92 that temporarily stores various data, and a ROM 93 that stores a control program. Connected to the CPU 91 are an operation unit 94 for a user to input instructions to the control device 90, a hard disk device 95 for storing various data and programs, and a display 96 for displaying various information. As the control device 90, a personal computer may be used, or a dedicated control device may be used.

  Further, a revolution controller 97, a rotation controller 98, and a measurement controller 99 are connected to the CPU 91. The revolution controller 97 controls the revolution of the inspection chip 2 by transmitting a control signal for rotating the spindle motor 35 to the spindle motor 35. The rotation controller 98 controls the rotation of the inspection chip 2 by transmitting a control signal for rotating the stepping motor 51 to the stepping motor 51. The measurement controller 99 performs the optical measurement of the inspection chip 2 by driving the measurement unit 7. Specifically, the measurement controller 99 transmits a control signal for executing light emission of the light source 71 and light detection of the optical sensor 72 to the light source 71 and the optical sensor 72. The CPU 91 controls the revolution controller 97, the rotation controller 98, and the measurement controller 99. In the hard disk device 95, various parameters and the like of the test chip 2 to be described later, physical property values of samples and reagents, and the like are stored in advance.

<4. Structure of inspection chip 2>
With reference to FIG.2 and FIG.3, the detailed structure of the test | inspection chip 2 which concerns on this embodiment is demonstrated. In the following description, the upper, lower, left, right, front side, and back side of FIG. 2 are the upper, lower, left, right, front, and rear sides of the inspection chip 2, respectively. .

  As shown in FIGS. 2 and 3, the inspection chip 2 has a square shape including an upper side portion 21, a right side portion 22, a left side portion 23, and a lower side portion 24 when viewed from the front as an example, and has a predetermined thickness. Mainly a transparent synthetic resin plate 20. As shown in FIG. 2, the front surface 201 of the plate member 20 is sealed with a sheet 291 made of a transparent synthetic resin thin plate. As shown in FIG. 3, the rear surface 202 opposite to the front surface 201 is sealed with a sheet 292 made of a transparent synthetic resin thin plate. As shown in FIGS. 2 and 3, a liquid flow path 25 is formed between the plate material 20 and the sheet 291 and between the plate material 20 and the sheet 292 so that the liquid sealed in the inspection chip 2 can flow. Has been. The liquid channel 25 is a recess formed at a predetermined depth on the front surface 201 side and the rear surface 202 side of the plate material 20, and extends in a direction orthogonal to the front-rear direction, which is the thickness direction of the plate material 20. The sheets 291 and 292 seal the flow path forming surface of the plate material 20. The sheets 291 and 292 are not shown except for FIGS.

  The liquid channel 25 includes the sample quantification channel 11, the reagent quantification channels 13 and 15, the first connection channel 301, the second connection channel 331, the mixing unit 80, the measurement unit 81, and the like. As shown in FIG. 2, the reagent fixed amount flow path 13 is provided in the upper left part of the front surface 201. The sample quantitative flow path 11 is provided on the right side of the reagent quantitative flow path 13 in the front surface 201. As shown in FIG. 3, the reagent fixed amount flow path 15 is provided in the upper left part on the rear surface 202 side. The mixing unit 80 is provided in the lower right part of the front surface 201. The mixing unit 80 is an area including a flow channel on the right side of an inflow port 306 to be described later, which is connected to a later-described separation component first guide unit 117 and extends downward. The measurement unit 81 is a lower part of the mixing unit 80.

  A configuration common to the reagent quantitative channels 13 and 15 will be described. As shown in FIGS. 2 and 3, the reagent quantification channels 13 and 15 include an inlet 130, a reagent injection part 131, a communication path 154, a first holding part 132, a second holding part 133, a capturing part 160, respectively. The reagent fixed quantity part 134, the 1st guide part 138, the 2nd guide part 137, and the reagent surplus part 136 are included. The reagent injection part 131 is provided in the upper left part of the test chip 2. The reagent injection part 131 is a recess that opens upward. A wall portion 27 is provided between the reagent injection portion 131 and the first holding portion 132. The wall portion 27 extends obliquely upward to the right from the left side portion 23 toward the upper side portion 21 to form a reagent injection portion 131. A reagent quantitative unit 134 is provided below the second holding unit 133. The reagent quantification part 134 is a part where the reagent 16 is quantified, and is a concave part recessed in the lower left.

  The inlet 130 penetrates the plate member 20 from the upper part of the reagent injection part 131 toward the upper side part 21 of the test chip 2. The inlet 130 is a part where the first reagent 18 or the second reagent 19 is injected into the reagent injection part 131. The reagent injection part 131 of the reagent fixed amount flow channel 13 is a part where the first reagent 18 injected from the injection port 130 of the reagent fixed amount flow channel 13 is stored. The reagent injection part 131 of the reagent fixed amount flow channel 15 is a part where the second reagent 19 injected from the injection port 130 of the reagent fixed amount flow channel 15 is stored. In addition, the 2nd reagent 19 of this embodiment is a reagent mixed after the 1st reagent 18 and the separation component 17A mentioned later are mixed. In the following description, the first reagent 18 and the second reagent 19 are collectively referred to as “reagent 16” when not specified either. The separation component 17A is also referred to as “sample after separation”.

  As shown in FIGS. 2 and 3, the first holding part 132 is a concave part that opens leftward, which is a direction that intersects the upward direction that is the opening direction of the reagent injection part 131. The first holding part 132 and the reagent injection part 131 are connected via a communication passage 154 extending in the left-right direction. The first holding part 132 includes a flow path extending downward from the right side portion of the communication path 154 on the left side, and is connected to the lower second holding part 133 via this flow path. Hereinafter, the “direction intersecting the opening direction of the reagent injecting portion 131” refers to a “direction toward the left direction parallel to the extending direction of the upper side portion 21”. The communication direction extending in the left-right direction of the communication path 154 is referred to as “communication direction R”.

  The first holding portion 132 is a recess formed by the lower wall surface 21A of the upper side portion 21, the first wall surface 132A of the first wall portion 132C, and the vertical wall surface 132B. The first wall surface 132A is a wall surface facing the lower wall surface 21A. The vertical wall surface 132B is a wall surface connecting the one end portion of the first wall surface 132A and the upper side portion 21. In addition, the protruding portion 132E protrudes from the tip end portion 132D side of the first wall surface 132A in the direction intersecting the first wall surface 132A and to the second holding portion 133 side. The protruding portion 132E includes a first tip portion 132F on the second holding portion 133 side, an inner wall surface 132G, and an outer wall surface 132H. The inner wall surface 132G is a wall surface that extends from the first tip portion 132F in the direction of the first wall portion 132C and faces a second wall surface 133B described later of the second holding portion 133. The outer wall surface 132H is a wall surface extending from the first tip portion 132F to the tip portion 132D.

  The second holding part 133 is a bent wall surface that opens in a direction intersecting the opening direction of the reagent injection part 131. Specifically, the second holding unit 133 is connected to the first wall surface 133A inclined toward the reagent quantitative unit 134A provided in the lower left portion of the test chip 2, and one end of the first wall surface 133A, and the first holding unit 133 The second wall surface 133 </ b> B extends in the direction toward the portion 132. In the present embodiment, the second holding portion 133 has a first wall surface 133A extending from a bending point 133G with the second wall surface 133B toward the lower left direction, and a second wall surface 133B having an upper right from the bending point 133G with the first wall surface 133A. It is a bent wall surface formed by extending in the direction. The first wall surface 132A of the first holding portion 132 extends in the lower left direction from the connection portion with the vertical wall surface 132B. Therefore, the lower left end portion 132D of the first wall surface 132A is located closer to the second holding portion 133 than the connection portion between the first wall surface 132A and the vertical wall surface 132B in the opening direction.

  The reagent quantification unit 134A is connected to the mixing unit 80 through the first guide unit 138 and the first connection channel 301, and is connected to the reagent surplus unit 136 through the second guide unit 137. The end on the mixing unit 80 side of the reagent quantitative unit 134A is referred to as a first end 141. The end of the reagent quantification unit 134A opposite to the mixing unit 80 is referred to as a second end 142. A surface connecting the first end portion 141 and the second end portion 142 is a reagent fixed amount surface 146. The reagent quantification surface 146 is a virtual surface that is the position of the upper surface of the reagent 16 when the reagent 16 is quantified by the reagent quantification unit 134A. Therefore, the volume of the liquid channel 25 below the reagent quantification surface 146 is the quantification amount in the reagent quantification unit 134A.

  The first wall surface 132A of the first holding part 132 has a tip part 132D that is an end part on the second holding part 133 side. The second wall surface 133B of the second holding part 133 has a second tip part 133C that is an end part on the first holding part 132 side. The tip portion 132D is provided at a position closer to the reagent injection portion 131 in the crossing direction than the second tip portion 133C. Accordingly, the first reagent 18 flows from the first holding unit 132 to the second holding unit 133 in the flow path between the reagent injection unit 131 and the reagent quantitative unit 134A. Further, since the tip portion 132D is closer to the reagent injection portion 131 in the crossing direction than the second tip portion 133C, the first reagent 18 that has flowed out of the first holding portion 132 flows into the second holding portion 133 and other parts. The possibility of flowing into the can be reduced.

  The front surface 201 of the inspection chip 2 is provided with a capturing unit 160 that is a recess that opens in a crossing direction from between the first tip portion 132F and the second tip portion 133C. When the first reagent 18 is injected from the reagent injection unit 131 to the first holding unit 132, the first reagent 18 overflowing from the first holding unit 132 flows into the capturing unit 160 and is held.

  A first guide 138 extends obliquely upward to the right from the upper part of the reagent fixed amount unit 134A. That is, the first guide portion 138 extends from the first end portion 141 toward the first connection channel 301. The first guide unit 138 is a flow path that guides the first reagent 18 quantified by the reagent quantification unit 134 </ b> A toward the measurement unit 81. The first guide portion 138 is connected to the first end portion 141 and bent, and the second guide portion 145 faces the first guide portion wall surface 145 and is a wall surface on the second holding portion 133 side. The side wall surface 149 is formed. The tip 310 of the first guide part wall surface 145 opposite to the first end 141 faces the second holding part side wall surface 149.

  From the upper part of the reagent fixed amount unit 134A, the second guide unit 137 extends obliquely downward to the left. That is, the second guide part 137 extends from the second end part 142 toward the reagent surplus part 136. The second guide part 137 is a flow path through which the reagent 16 overflowing from the reagent quantitative part 134A moves. A reagent surplus portion 136 is provided at the lower left of the reagent fixed amount portion 134A. The reagent surplus part 136 is a part in which the reagent 16 that has moved through the second guide part 137 is accommodated, and is a concave part provided downward and rightward from the lower end part of the second guide part 137. In the second guide portion 137, a wall surface 144 extends from the second end portion 142 of the reagent fixed amount portion 134A toward the reagent surplus portion 136. The reagent 16 overflowing from the reagent quantitative unit 134A flows on the wall surface 144 and flows into the reagent surplus unit 136.

  The first connection channel 301 will be described. In the following description, the reagent quantitative unit 134 of the reagent quantitative channel 13 is referred to as a reagent quantitative unit 134A, and the reagent quantitative unit 134 of the reagent quantitative channel 15 is referred to as a reagent quantitative unit 134B. The first connection channel 301 is a channel formed on the front surface 201 and connecting the first guide part 138 and the mixing part 80. The first connection channel 301 extends obliquely downward to the right from the distal end portion 310 of the first guide portion wall surface 145 of the first guide portion 138, includes a reagent receiving portion 305, and is connected to the inflow port 306.

  The reagent receiver 305 is provided on the lower side 24 side of the first connection channel 301 and is connected to the inflow port 306. The inflow port 306 is located on the left side of the mixing unit 80 and is a part for allowing the reagent 16 to flow into the mixing unit 80. A confluence hole portion 351 is provided on the left side of the reagent receiving portion 305. The merge hole 351 is a hole that penetrates the plate member 20 in the front-rear direction and joins the second connection channel 331 to the first connection channel 301.

  The second connection channel 331 will be described. As shown in FIG. 3, the second connection channel 331 is formed on the rear surface 202 and extends from the reagent quantification unit 134B to the merging hole 351 side, and is a channel that connects the reagent quantification unit 134B and the merging hole 351. is there. The second connection channel 331 includes two reagent receiving portions 341 and 342. The reagent receiving parts 341 and 342 are parts that receive the second reagent 19 quantified by the reagent quantifying part 134B. The second connection channel 331 extends obliquely upward to the right from the reagent determination unit 134B and is connected to the reagent receiver 341, and extends obliquely downward to the left from the reagent receiver 341 and is connected to the reagent receiver 342. The right end portion of the reagent receiving portion 342 is connected to the merge hole portion 351 and is connected to the first connection channel 301 on the front surface 201 side.

  The specimen quantification channel 11 will be described. As shown in FIG. 2, the sample fixed amount flow path 11 includes an injection port 110, a sample injection unit 111, a first sample holding unit 112, a sample guide unit 113, a separation unit 124, a channel 125, a channel 127, a sample surplus unit 126, A second sample holding unit 123, a sample quantitative unit 114, a separation component second guide unit 115, a separation component first guide unit 117, and a second surplus unit 116 are included. The sample injection part 111 is provided on the right side of the first holding part 132 of the reagent fixed amount flow path 13. The specimen injection unit 111 is a recess that opens upward. The injection port 110 penetrates the plate material 20 from the upper part of the specimen injection part 111 toward the upper side part 21 of the test chip 2. The injection port 110 is a part where the sample 17 is injected into the sample injection unit 111. The specimen injection unit 111 is a part where the specimen 17 injected from the injection port 110 is stored. The specimen 17 of the present embodiment is a liquid containing components such as blood, plasma, blood cells, bone marrow, urine, vaginal tissue, epithelial tissue, tumor, semen, saliva, or foodstuff. The first sample holding unit 112 and the sample injection unit 111 are connected via a communication path extending in the left-right direction. The first sample holder 112 is a recess that opens in the direction of the sample injector 111. The lower end portion of the first sample holding unit 112 is connected to the sample guide unit 113 that is a passage.

  A separation unit 124 is provided below the sample guide unit 113. The sample guide unit 113 guides the sample 17 to the separation unit 124. The separation unit 124 is a part where components contained in the specimen 17 are separated. The separation unit 124 centrifuges the specimen 17 into a component having a small specific gravity and a component having a large specific gravity by the action of centrifugal force. In the following description, a component having a small specific gravity of the specimen 17 separated by the separation unit 124 is referred to as a separation component 17A, and a component having a large specific gravity is referred to as a residual component 17B.

  The connecting channel 120 extends obliquely upward to the right from the center in the vertical direction on the right side surface of the separation unit 124, and the upper end of the connecting channel 120 is connected to the upper end of the component holding unit 121. The component holding unit 121 is a storage unit that holds at least a part of the residual component 17 </ b> B separated in the separation unit 124. That is, the specimen 17 before separation or the separated component 17A may flow into the component holding unit 121.

  From the upper part of the separation part 124, the passage 125 extends obliquely to the left and the passage 127 extends obliquely upward to the right. The passage 125 extends to the specimen surplus portion 126 provided on the lower left side of the separation portion 124. The specimen surplus part 126 is a part where the specimen 17 overflowing from the separation part 124 is stored.

  The passage 127 is connected to the second sample holding unit 123. A sample quantitative unit 114 is provided below the second sample holding unit 123. The specimen quantification unit 114 is a part that quantifies the separated component 17A, and is a recess that opens upward. The second specimen holding unit 123 includes a wall part 123C and a vertical wall surface 123B. The wall portion 123 </ b> C includes a first wall surface 123 </ b> A that is inclined in the direction of the specimen quantification unit 114. The vertical wall surface 123 </ b> B is an inner wall surface of the right side portion 22 connected to the end portion of the first wall surface 123 </ b> A on the side opposite to the specimen quantification unit 114. The first wall surface 123A includes a distal end portion 123D that is an end portion in the direction of the specimen quantification unit 114. The tip of the wall portion 123C in the direction of the specimen quantification unit 114 is the tip portion 123F. A flow path between the distal end portion 123D and the distal end portion 123F is a sample guide portion 128 that guides the separation component 17A toward the sample fixed amount portion 114.

  The sample quantification unit 114 is connected to the mixing unit 80 via the separated component first guide unit 117, and is connected to the second surplus unit 116 via the separated component second guide unit 115. The end on the mixing unit 80 side of the sample quantitative unit 114 is referred to as a first sample quantitative unit end 118. The end of the sample quantitative unit 114 opposite to the mixing unit 80 is referred to as a second sample quantitative unit end 119. A surface connecting the first sample quantitative portion end 118 and the second sample quantitative portion end 119 is a sample quantitative surface 129. The sample quantification surface 129 is a virtual surface serving as the position of the upper surface of the separation component 17A when the separation component 17A is quantified by the sample quantification unit 114. Therefore, the volume of the liquid channel 25 below the sample quantification surface 129 is the quantification amount in the sample quantification unit 114. The sample quantification unit 114 is formed below the sample quantification surface 129 and shallower than the upper side. The second surplus part 116 is a part where the separated component 17A overflowing from the specimen quantification part 114 is stored.

  The mixing unit 80 is connected to the sample quantitative unit 114 via the separated component first guide unit 117. The mixing unit 80 is connected to the reagent quantitative unit 134A via the first connection channel 301. The mixing unit 80 is connected to the reagent quantification unit 134B via the second connection channel 331. In the mixing unit 80, the separated component 17A quantified in the sample quantification unit 114, the first reagent 18 quantified in the reagent quantification unit 134A, and the second reagent 19 quantified in the reagent quantification unit 134B are mixed. When optical measurement described later is performed, the measurement light is transmitted to the measurement unit 81 that forms the lower part of the mixing unit 80.

  Next, referring to FIGS. 2, 4, and 5, the first holding unit 132, the second holding unit 133, the second sample holding unit 123, the reagent quantitative unit 134 </ b> A, and the sample quantitative unit 114 of the test chip 2. Details of the structure will be described. The CPU 91 shown in FIG. 1 controls the revolution controller 97, starts driving the spindle motor 35, and the turntable 33 rotates at a predetermined speed. Further, the CPU 91 controls the rotation controller 98 to drive and control the stepping motor 51, and the inspection chip 2 is rotated to the state shown in FIGS. This state is a state where the outflow of the reagent from the second holding part 133 starts as shown in FIG. In addition, as shown in FIG. 5, the separation component 17 </ b> A starts to flow out from the second specimen holding unit 123.

  In the following description, an angle α1, an angle α2, and an angle α3 described later are collectively referred to as an angle α. Further, an angle β1, an angle β2, and an angle β3 described later are collectively referred to as an angle β. As shown in FIG. 4, the volume of the reagent surrounded by the first wall surface 132A and the vertical wall surface 132B forming the first holding portion 132 and the first virtual surface 132K passing through the tip portion 132D of the first wall surface 132A is volume V1. It is. An acute angle formed by the first virtual surface 132K with respect to the communication direction R of the communication path 154, that is, the right direction is an angle α3. An acute angle formed by the first wall surface 132A with respect to the communication direction R is an angle β3. In the first holding part 132, the angle α3 is larger than the angle β3.

The second holding part 133 includes a first wall surface 133A and a second wall surface 133B. 133 A of 1st wall surfaces incline toward the reagent fixed_quantity | quantitative_assay part 134A. The second wall surface 133B is connected to the end portion of the first wall surface 133A opposite to the tip portion 133D, and extends in the direction of the first holding portion 132. The end of the first wall surface 133A on the reagent quantification part 134A side is a tip part 133D. Further, the protruding portion 133E protrudes from the distal end portion 133D toward the reagent fixed amount portion 134A, and the distal end portion of the protruding portion 133E is the distal end portion 133F. The volume of the reagent surrounded by the first wall surface 133A and the second wall surface 133B forming the second holding portion 133 and the first virtual surface 133K passing through the tip portion 133D of the first wall surface 133A is the volume V2. An acute angle formed by the first virtual surface 133K with respect to the communication direction R is an angle α2. An acute angle formed by the first wall surface 133A with respect to the communication direction R is an angle β2. In the second holding part 133, the angle α2 is larger than the angle β2.

  The sum of the volume V1 and the volume V2 shown in FIG. 4 is the same as the volume V0 that is a predetermined injection amount of the reagent injected into the reagent injection part 131 shown in FIG. The volume V0, which is a predetermined injection amount, is determined as follows as an example. As shown in FIGS. 2 and 4, a ridge line 131 </ b> A slightly raised from the flow path may be formed in the reagent injection part 131. A volume surrounded by the ridge line 131A shown in FIG. 4 and the wall surface 23A, the wall surface 27A, and the wall surface 27B forming the reagent injection part 131 is a volume V0 of a predetermined injection amount into the reagent injection part 131. Further, the ridge line 131A may not be provided, and a reference line may be provided in the injection device, and the volume from the tip to the reference line may be a volume V0, as in a well-known hole pipette. When the tip is brought into contact with a liquid such as a specimen or a reagent, the liquid is sucked into the injection device by capillary force. The user can inject a liquid of volume V0 into the injection part with reference to the reference line. Therefore, in any case, the injection amount is predetermined. The volume V0 is not less than a fixed amount.

  In the second holding part 133, since the angle α2 is larger than the angle β2 and the angle α3 is larger than the angle β3, the reagent 18 having a predetermined injection amount V0 of the reagent into the reagent injecting part 131 is added to the first holding part 132 and the second holding part 133. The two holding parts 133 hold each of them. The first virtual surface 133K and the first virtual surface 132K are parallel. That is, the angle α3 and the angle α2 are the same. Further, the angle β3 may be equal to or larger than the angle β2.

  As shown in FIG. 2, in the test chip 2, the quantitative amount of the reagent quantitative unit 134 </ b> A is larger than the quantitative amount of the sample quantitative unit 114. That is, the amount injected into the reagent quantitative unit 134A is larger than the amount injected into the sample quantitative unit 114, and the reagent injected into the reagent quantitative unit 134A hits the first guide unit wall surface 145 of the first guide unit 138 and flows downstream. Need to prevent. In the inspection chip 2 of the present embodiment, as shown in FIG. 4, in the second holding part 133, a tangent line that is orthogonal to the first virtual surface 133K and is in contact with the tip part 133F is the first virtual line 133H. In the reagent quantification unit 134A, the first virtual line 133H passes through the first end 141 side from the second end 142. In the present embodiment, the first imaginary line 133H passes between the first end portion 141 and the second end portion 142, but intersects the first guide portion wall surface 145 on the right side of the first end portion 141. Also good. Therefore, when the reagent held in the second holding unit 133 flows into the reagent quantitative unit 134A, the reagent flows along the first imaginary line 133H. Since the first imaginary line 133H passes the first end 141 side from the second end 142, the reagent flowing into the reagent quantification unit 134A is less likely to hit the second end 142, and the reagent quantification unit 134A. Flow into. Therefore, when the reagent flows into the reagent quantitative unit 134A, a gap is formed between the second end 142 of the reagent quantitative unit 134A and the flowing reagent. The air in the reagent quantitative unit 134A can escape out of the reagent quantitative unit 134A through this gap.

  As shown in FIG. 5, it is surrounded by a first wall surface 123A and a vertical wall surface 123B that form the second specimen holding portion 123 that holds the separation component 17A, and a first virtual surface 123K that passes through the tip portion 123D of the first wall surface 123A. The volume of the separated component 17A is the volume V01. An acute angle formed by the first virtual surface 123K with respect to the communication direction R shown in FIG. 2 is an angle α1. An acute angle formed by the first wall surface 123A with respect to the communication direction R is an angle β1. The volume V01 of the separation component 17A will be described with reference to FIGS. The volume surrounded by the fifth virtual surface 148 extending in the communication direction R (see FIG. 2) direction from the end portion 147 of the separation portion 124 on the passage 125 side shown in FIG. 11 and the wall surface of the separation portion 124 is the volume V11. The volume of the connection channel 120 on the separation unit 124 side from the virtual line 120K extending in parallel with the fifth virtual surface 148 from the end 120A of the connection channel 120 is the volume V12. The end 120 </ b> A of the connection channel 120 is located closest to the centrifugal direction at the time of separation among the wall surfaces on the side of the passage 127 forming the circular blood flow. The sum of the volume V11 and the volume V12 is the volume V10. The centrifugal force F0 acts perpendicularly to the fifth virtual plane 148 and the virtual line 120K. As shown in FIG. 12, in the separation portion 124, the volume surrounded by the second virtual surface 151 passing through the first end portion 143 and the wall surface forming the separation portion 124, and the virtual surface 155 and the separation portion in the connection channel 120. The sum of the volume surrounded by the wall surface forming the connection flow path 120 on the 124 side is V13. The second virtual surface 151 and the virtual surface 155 are parallel to each other, and the virtual surface 155 forms the connection channel 120 and includes a tangent line of the opposing wall surface. Therefore, as shown in FIG. 12, the extraction amount V01 from the separation unit 124 is a volume obtained by subtracting V13 from V10. Accordingly, as shown in FIG. 12, the separated component 17 </ b> A with the extraction amount V <b> 01 is held in the second sample holding unit 123. As shown in FIG. 5, in the second specimen holding unit 123, the angle α1 is larger than the angle β1. In the second sample holding unit 123, the angle α1 is larger than the angle β1, so the separated component 17A from the separation unit 124 is held by the second sample holding unit 123.

  Further, as shown in FIG. 2, in the test chip 2, since the quantitative amount of the sample quantitative unit 114 is smaller than the quantitative amount of the reagent quantitative unit 134A, if the separated component injected into the sample quantitative unit 114 rebounds, It tends to flow outside the portion 114. As a result, there is a possibility of insufficiency of quantitative determination. In the present embodiment, as shown in FIG. 5, in the second specimen holding portion 123, a tangent line that is orthogonal to the first virtual surface 123 </ b> K and is in contact with the distal end portion 123 </ b> F of the wall portion 123 </ b> C of the second specimen holding portion 123. One imaginary line 123H. In the present embodiment, the first virtual line 123H passes through the first sample quantification unit end 118 side from the second sample quantification unit end 119 in the sample quantification unit 114, but the first sample quantification unit end 118 is present. Alternatively, the separation component first guide part 117 on the right side may be formed and intersect with the first guide wall surface 117A connected to the first sample quantitative part end part 118. Desirably, among the angles formed by the first guide wall surface 117A and the first virtual line 123H, the angle θ1 on the separated component first guide portion 117 side is less than 90 degrees.

  Therefore, when the separation component held in the second sample holding unit 123 flows into the sample quantification unit 114, it flows along the first virtual line 123H. Since the first virtual line 123H passes from the second sample quantification unit end 119 to the first sample quantification unit end 118 side, the separated component flowing into the sample quantification unit 114 hits the second sample quantification unit end 119. It flows into the specimen quantification unit 114 without reducing the possibility. In addition, since the angle on the separation component first guide portion 117 side is less than 90 degrees among the angles formed by the first guide wall surface 117A and the first imaginary line 123H, the separation component 17A is at the end of the second sample quantification portion. The possibility of hitting 119 can be reduced. Further, the separation component 17A hits the first guide wall surface 117A at an acute angle and flows into the sample quantification unit 114 from the first sample quantification unit end 118 side. Accordingly, after the separated component is filled in the sample quantitative unit 114, the separated component overflows from the second sample quantitative unit end 119. Therefore, when the separated component flows into the sample quantitative unit 114, a gap is formed between the second sample quantitative unit end 119 of the sample quantitative unit 114 and the flowing separated component. The air in the sample quantitative unit 114 can escape out of the sample quantitative unit 114 through this gap. Therefore, the possibility of air remaining on the second end side of the sample quantification unit 114 can be reduced, and the quantification accuracy of the sample or reagent can be improved.

  As shown in FIG. 5, in the second specimen holder 123, the angle β1 formed by the first wall surface 123A with respect to the communication direction R shown in FIG. 2 is determined by the first wall surface 133A of the second holder 133 shown in FIG. It is smaller than the angle β2 formed with respect to the communication direction R. Further, the ratio of the quantitative amount of the specimen quantifying unit 114 to the outflow amount V01 of the separated component 17A flowing out from the separating unit 124 shown in FIG. 5 is a predetermined injection of the reagent 18 into the reagent injecting unit 131 shown in FIG. The position of the separation unit 124, the component holding unit 121, the connection channel 120, the sample quantification unit 114, the reagent injection unit 131, and the reagent quantification unit 134A and the ratio of the quantification amount of the reagent quantification unit 134A to the amount V0 The size is fixed.

  Since the magnitude relationship between these quantitative amounts is determined, in order to improve the quantitative accuracy of the separated component in the sample quantitative unit 114, it is necessary to inject the separated component into the sample quantitative unit 114 more reliably. In order to satisfy the above magnitude relationship, there is one of the following methods. First method: The outflow amount V01 to the specimen quantification unit 114 is made smaller than the injection amount V0 to the reagent quantification unit 134A. Second method: The sample quantitative amount of the separation component 17A in the sample quantitative unit 114 is made larger than the quantitative amount of the reagent 18 in the reagent quantitative unit 134A. In the present embodiment, since the quantitative amount of the sample quantitative unit 114 is smaller than the quantitative amount of the reagent quantitative unit 134A, it is necessary to satisfy the first method. If the outflow amount V01 of the separated component 17A to the sample quantifying unit 114 is small, the separation component 17A may be insufficient if the separated component 17A does not accurately flow into the sample quantifying unit 114. Therefore, it is necessary to inject the separated component 17A into the sample quantitative unit 114 more reliably.

For this purpose, the first timing at which the excess separation component 17A flows out from the second sample quantification unit end 119 of the sample quantification unit 114 and the direction of the centrifugal force F are perpendicular to the first wall surface 123A, and the sample quantification unit It is necessary to lengthen the period from the second timing at which the injection of the separation component 17A into 114 ends. The first timing is a period until the direction of the centrifugal force F is perpendicular to the first virtual surface 123K of the second specimen holding unit 123 and thereafter the direction of the centrifugal force F is perpendicular to the first wall surface 123A. included. The first timing may be changed to the second timing, or the second timing may be changed to the first timing. However, it is preferable that the first timing is changed to the second timing. For this purpose, it is necessary to increase the difference between the angle α1 at which the separation component held in the second specimen holding unit 123 flows out and the angle β1 formed by the first wall surface 123A with respect to the communication direction R.

  To increase the difference between the angle α1 and the angle β1, as an example, it is conceivable to increase the angle α1. In this case, it is necessary to increase the amount of the separation component 17A injected into the specimen quantitative unit 114. The separated component 17A injected into the sample quantification unit 114 is the sample after being separated by the separation unit 124. Therefore, if the amount of the separation component 17A injected into the sample quantification unit 114 is increased, it is necessary to increase the amount of the sample before separation, and the sample injection unit 111 becomes larger and the outer shape of the test chip 2 becomes larger. In order to increase the difference between the angle α1 and the angle β1, as an example, it is conceivable to decrease the angle β1. In this case, without increasing the outer shape of the test chip 2, the timing at which the excess sample flows out from the second sample quantification unit end 119 of the sample quantification unit 114 and the direction of the centrifugal force F are perpendicular to the first wall surface 123A. It is possible to lengthen the period with the timing.

  Further, the ratio of the quantitative amount of the specimen quantitative unit 114 to the volume V01 of the outflow amount of the separation component 17A flowing out from the separation unit 124 is such that the reagent quantitative unit 134A of the reagent quantitative unit 134A with respect to the predetermined injection amount V0 of the reagent into the reagent injection unit 131 Since it is larger than the ratio of the fixed amount, the amount of the separated component 17A that flows into the separated component second guide portion 115 and is wasted is reduced. Therefore, it is not necessary to increase the size of the sample injection part 111 into which the sample 17 is injected. Therefore, it is possible to reduce the necessity of increasing the outer shape of the inspection chip 2.

  The following description is based on the SI unit system. As shown in FIG. 5, a sample guide unit 128 through which the separated component 17 </ b> A flows is formed from the second sample holding unit 123 toward the sample determination unit 114. The specimen guide unit 128 is formed of opposing wall surfaces, and the opposing wall surfaces extend in the up-down direction. One of the wall surfaces is connected to a first wall surface 123A extending in the lower left direction. The cross-sectional area between the opposing wall surfaces is “S”, and the length is “L”. The acute angle formed by the inclined surface 115A connected to the second sample quantification unit end 119 of the sample quantification unit 114 and constituting the separated component second guide unit 115 with respect to the communication direction R is “angle θ2”. The separated component 17A overflowing from the sample quantification unit 114 flows into the second surplus unit 116 along the inclined surface 115A. The width of the opening between the second sample quantification unit end 119 of the sample quantification unit 114 and the second sample quantification unit end 119 of the first sample quantification unit end 118 is “d2”. The depth of the opening between the first sample quantification unit end 118 and the second sample quantification unit end 119 is “w”. The mass of the volume V01 of the separated component 17A that passes through the sample guide unit 128 and flows into the sample determination unit 114 is “m”. The gravitational acceleration is “g”. The surface tension of the separation component 17A is “T”, and the contact angle of the liquid of the separation component 17A is “δ”. These parameters are stored in the HDD 95 in advance.

  As shown in FIGS. 5 and 9A, when the separated component 17A is injected from the second sample holding unit 123 through the sample guide unit 128 to the sample quantitative unit 114, the second sample holding unit A first centrifugal force F0 is applied perpendicularly to the first virtual surface 123K of 123. The application direction of the first centrifugal force F0 is the “first centrifugal direction”. From this state, from the second sample holder 123? The separation component 17A starts to flow into the sample quantitative unit 114 after passing through the sample guide unit 128. Next, the test chip 2 is rotated so that the first centrifugal force F0 is applied perpendicularly to the first wall surface 123A of the second specimen holding unit 123. The application direction of the first centrifugal force F0 in this case is the “second centrifugal direction”. The centrifugal process is performed by the CPU 91 of the control device 90 shown in FIG. 1 by controlling the revolution controller 97 and the rotation controller 98. Specifically, the CPU 91 controls the revolution controller 97 to start driving the spindle motor 35 and the turntable 33 rotates at a predetermined speed, while the CPU 91 controls the rotation controller 98 to set the stepping motor 51 in a predetermined step. Only drive control.

The injection time related to the injection of the separation component 17A into the specimen quantification unit 114 is “time t”. The time t is the time from when the first centrifugal force F0 starts to be applied in the first centrifugal direction to when the direction in which the first centrifugal force F0 is applied changes in the second centrifugal direction. The period from when the first centrifugal force F0 is applied perpendicularly to the first virtual surface 123K to when the first centrifugal force F0 is applied perpendicularly to the first wall surface 123A, that is, the separation component 17A is the second specimen holder. The magnitude of the first centrifugal force F0 applied in the first centrifugal direction and the second centrifugal direction during the period from 123 through the sample guide unit 128 and flowing into the sample determination unit 114 passes through the sample guide unit 128. It must be greater than the flow path resistance for the separation component 17A.
The channel resistance P [Pa] received from the wall surface when passing through the narrow channel is represented by P [Pa] = λ × (L / S) × (ρ × Va ² ) / 2 (Formula 3).
Where λ = (64 × ν) / (Va × S) (Formula 4)
Va = L / t (Formula 5)
ν = μ / ρ (Formula 6)
Substituting Equation 4, Equation 5, and Equation 6 into Equation 3,
P = (32 × μ × L ² ) / (S ² × t) (Expression 7)
By applying a centrifugal force larger than the flow path resistance P, the liquid can be discharged from the narrow flow path. The centrifugal force at the time of outflow is expressed by the centrifugal force = P × S / (m × g) (formula 8) using the cross-sectional area where pressure is applied, the mass of the moving liquid, and the gravitational acceleration.
Substituting (Equation 7) into (Equation 8),
Centrifugal force = 32 × μ × L ² / (S × t × m × g) (Expression 9)
Therefore, the CPU 91 controls the revolution controller 97 so that the magnitude of the first centrifugal force F0 is larger than (Equation 9), and the drive of the spindle motor 35 is started, so that the turntable 33 is at a predetermined rotational speed V0. Control to rotate. The rotation speed V0 is the number of rotations per second obtained in advance by an experiment using the inspection chip 2.

After the first centrifugal force F0 larger than the value of (Equation 9) is applied, as shown in FIG. 9B, the third direction which is perpendicular to the sample quantification surface 129 of the sample quantification unit 114 shown in FIG. A second centrifugal force F1 is applied in the centrifugal direction. The magnitude F1 of the second centrifugal force applied in the third centrifugal direction is
F1> (2 × (d2 + w) × T × cos δ × cos θ2 / cos (90−θ2)) + 1 (Formula 10)
The CPU 91 controls the revolution controller 97 so that the spindle motor 35 starts to be driven so that the turntable 33 rotates at a predetermined rotational speed V1. The rotation speed V1 is the number of rotations per second obtained in advance by an experiment using the inspection chip 2.

L2 = 2 × (d2 + w) (Equation 11) where the peripheral length of the opening of the first sample quantification unit end 118 and the second sample quantification unit end 119 of the sample quantification unit 114 is “L2”.
Fst = L2 × T cos α (Formula 12)
When the holding force that does not allow the separation component 17A to flow out from the sample determination unit 114 is “F2”,
F2 = Fst / cos (90−θ2) (Formula 13)
If gravity is F3, F3 = 1 (Formula 14)
The second centrifugal force F1 required in this case is
F1> F2 × cos θ2 + F3 (Formula 15)
By substituting Equations 11 to 14 into Equation 15, Equation 10 is obtained.

  In the case shown in FIG. 5, the opening area S of the sample guiding unit 128 is narrower than the opening width d2 of the sample quantifying unit 114 and narrower than the opening width d2 ′ of the reagent quantifying unit 134A. The channel resistance is larger than the channel resistance of the reagent guide unit. Therefore, the separation component 17A hardly flows due to the flow path resistance of the specimen guide unit 128, and the separation component 17A is not filled in the specimen quantitative unit 114 before the second centrifugal force F1 is applied in the third centrifugal direction, and the second centrifugal force F1. Is applied, the second centrifugal force F1 is applied in the vertical direction to the sample quantification surface 129 of the sample quantification unit 114, so that the separation component 17A directly hits the sample quantification surface 129 and the liquid level is recessed, resulting in a quantification amount. There may be a shortage. When the separation component 17A is injected into the specimen quantification unit 114, the first centrifugal force F0 is applied in the first centrifugal direction, and then the first centrifugal force F0 is applied in the second centrifugal direction, and further the third centrifugal direction. The second centrifugal force F1 is applied to. Therefore, even when the flow path resistance is large, before the second centrifugal force F0 acting in the third centrifugal direction is applied, the sample quantification unit 114 is filled with the separation component 17A, and the second sample quantification unit end 119 The separation component 17A can be started to flow out to the separation component second guide 115 side. Therefore, in order to regulate the inflow amount of the separation component 17A to the specimen quantification unit 114, the liquid width of the inflowing liquid of the separation component 17A is limited by both the first wall surface 123A and the flow path resistance of the specimen guide unit 128. The separation component 17A comes into contact with the second sample quantification unit end 119 and the possibility of air remaining on the second sample quantification unit end 119 side of the sample quantification unit 114 is reduced, and the sample quantification accuracy is improved. be able to. Further, since the sample quantitative unit 114 has a small quantitative amount, the cross-sectional area of the sample quantitative surface 129 is small, and when a centrifugal force is applied perpendicular to the sample quantitative surface 129, the holding force held by the sample quantitative surface 129 is weak. During the holding, the separation component 17A tends to flow out to the second sample quantitative portion end 119 side. Accordingly, the second centrifugal force F1 related to the sectional area of the quantitative surface is applied to hold the separated component 17A on the specimen quantitative surface 129 without the separated component 17A flowing out to the second specimen quantitative part end 119 side. Thus, the separated component 17A can be held on the specimen quantification surface 129.

  Further, as shown in FIG. 4, the acute angle θ ′ formed with respect to the communication direction R by the inclined surface 137A connected to the second end 142 of the reagent quantitative unit 134A and constituting the second guide unit 137, the reagent quantitative The opening width d2 ′ of the first end portion 141 and the second end portion 142 of the portion 134A, the depth w ′ of the reagent quantitative portion 134A between the first end portion 141 and the second end portion 142, and the surface of the reagent 18 The tension T ′ and the contact angle δ ′ of the liquid of the reagent 18 are stored in advance in the hard disk device 95 of the control device 90. As shown in FIGS. 4 and 7B, when the reagent 18 is injected into the reagent quantitative unit 134A, a third centrifugal force different from the first centrifugal force F0 is applied in the first centrifugal direction and the second centrifugal direction. The CPU 91 controls the revolution controller 97 so as to act, and starts to drive the spindle motor 35 to control the turntable 33 to rotate at a predetermined rotation speed V3. The rotation speed V3 is the number of rotations per second obtained in advance by an experiment using the inspection chip 2. The rotation speed V3 differs depending on the parameters of the test chip 2 and the physical property values of the reagent 18.

Next, as shown in FIG. 7C, the CPU 91 controls the revolution controller 97 so that the two centrifugal force F1 larger than the three centrifugal force is applied to the inspection chip 2 in the third centrifugal direction, and the spindle motor 35 The driving is started and the turntable 33 is controlled to rotate at a predetermined rotational speed V1. The second centrifugal force F1 is
F1> (2 × (d2 ′ + w ′) × T ′ × cos δ ′ × cos θ ′ / cos (90−θ ′)) + 1 (Expression 16)
Greater than. The rotation speed V1 is the number of rotations per second obtained in advance by an experiment using the inspection chip 2. The rotation speed V1 varies depending on the parameters of the inspection chip 2 and the physical properties of the separation component 17A.

In the above case, the opening area s ′ of the reagent guide part 139 is formed wider than the opening area s of the sample guide part 128. Therefore, when the reagent 18 passes through the reagent guide part 139, it is not necessary to apply a centrifugal force to overcome the flow path resistance from the narrow flow path as in the case where the separation component 17A passes through the sample guide part 128. The second centrifugal force F1 is
F1> (2 × (d2 ′ + w ′) × T ′ × cos δ ′ × cos θ ′ / cos (90−θ ′)) + 1 (Expression 17)
Since it is applied so as to be larger, the reagent 18 can be injected into the reagent quantitative unit 134A without leaving the reagent 18 on the first wall surface 133A of the second holding unit 133.

（式１８）になるようにし、
検体定量部１１４へ分離成分１７Ａが注入される場合には、
時間ｔ１が

（式１９）
になるように制御装置９０のＣＰＵ９１が公転コントローラ９７を制御し、主軸モータ３５の駆動を開始してターンテーブル３３が所定の回転速度で回転するように制御する。
式１８は、検体定量部１１４に分離成分１４Ａが注入されるときに、液面が移動する距離Ｌｍは、検体定量部１１４の定量部底から液面が上昇し第二検体定量部端部１１９に液が到達するまでの液面の移動距離である。
この距離Ｌｍを移動する時間つまり検体定量部１１４への注入時の時間ｔは、加えられる遠心力による力（（２×（ｄ２’＋ｗ’）×Ｔ’×ｃｏｓδ’×ｃｏｓθ’／ｃｏｓ（９０−θ’））＋１）×ｇから算出される。式１９に付いても同様である。 As shown in FIG. 4, the length of the second imaginary line extending from the portion where the second imaginary surface 134K parallel to the first imaginary surface 133K contacts the bottom portion 134T of the reagent quantitative unit 134A to the second end 142 is Lm ′. Yes, as shown in FIG. 5, the length of the second imaginary line extending from the portion where the second virtual surface 134K parallel to the first virtual surface 123K is in contact with the bottom 114T of the sample quantitative unit 114 to the second sample quantitative unit end 119 Lm, and the centrifugal force applied to the test chip during the time t1 from when the centrifugal force is applied in the first centrifugal direction to when the first centrifugal force is applied in the second centrifugal direction is In the case of F0, the magnitude of the centrifugal force acting on the test chip 2 during the time t1 is such that when the reagent 18 is injected into the reagent quantitative unit 134A ,
Time t1 is

(Equation 18)
When the separation component 17A is injected into the sample quantitative unit 114,
Time t1 is

(Formula 19)
The CPU 91 of the control device 90 controls the revolution controller 97 so that the main shaft motor 35 starts to be driven so that the turntable 33 rotates at a predetermined rotational speed.
Equation 18 shows that when the separation component 14A is injected into the sample quantification unit 114, the distance Lm that the liquid level moves is such that the liquid level rises from the bottom of the quantification unit of the sample quantification unit 114 and the end 119 of the second sample quantification unit. It is the movement distance of the liquid surface until the liquid reaches.
The time for moving the distance Lm, that is, the time t at the time of injection into the specimen quantification unit 114 is the force ((2 × (d2 ′ + w ′) × T ′ × cosδ ′ × cosθ ′ / cos (90 −θ ′)) + 1) × g. The same applies to Equation 19.

  In this case, the opening area S ′ of the reagent guide unit 139 is formed wider than the opening area S of the sample guide unit 128. However, since the time t1 has the relationship of Equation 18, the reagent quantification unit The injection of the reagent 18 into 134A is performed slowly. Therefore, the reagent 18 injected into the reagent quantitative unit 134A does not flow from the reagent guide unit 139 all at once. Therefore, the liquid width of the reagent 18 to be injected can be narrowed down. Furthermore, the possibility of air remaining on the second end portion 142 side without reducing the reagent 18 injected into the second end portion 142 of the reagent quantifying portion 134A can be improved and the quantification accuracy of the reagent 18 can be improved. it can. In addition, the opening area S of the sample guiding unit 128 is narrower than the opening width d2 of the sample determining unit 114 and narrower than the opening area S ′ of the reagent guiding unit 139, but the time t1 has the relationship of Equation 19. Therefore, before the second centrifugal force F1 acts in the third centrifugal direction by quickly rotating the test chip 2, the sample quantitative unit 114 is filled with the separation component 17A, and the second sample quantitative unit The outflow of the separation component 17A can be started from the end to the separation component second guide portion 115 side. Therefore, it is possible to reduce the possibility that air remains in the second sample quantification unit end 119 of the sample quantification unit 114 and improve the quantification accuracy of the separated component 17A.

<5. Other structures of inspection chip 2>
As shown in FIG. 1, the support shaft 46 extending from the L-shaped plate 60 is vertically connected to the center of the rear surface of the mounting holder 61. As the support shaft 46 rotates, the inspection chip 2 rotates around the support shaft 46. When the inspection chip 2 is in the steady state shown in FIGS. 2 and 3, the upper side 21 and the lower side 24 are orthogonal to the direction of gravity G, the right side 22 and the left side 23 are parallel to the direction of gravity G, and The left side portion 23 is disposed closer to the main shaft 57 than the right side portion 22. In a state where the inspection chip 2 in the steady state is arranged at the measurement position, the inspection apparatus 1 performs inspection by optical measurement by allowing the measurement light connecting the light source 71 and the optical sensor 72 to pass through the measurement unit 81.

<6. Example of inspection method>
An inspection method using the inspection apparatus 1 and the inspection chip 2 will be described. As shown in FIG. 2, the sample 17 is injected from the injection port 110 and placed in the sample injection unit 111. The first reagent 18 is injected from the injection port 130 of the reagent fixed amount flow path 13 and is arranged in the reagent injection portion 131 of the reagent fixed amount flow path 13. As shown in FIG. 3, the second reagent 19 is injected from the inlet 130 of the reagent quantitative flow channel 15 and is arranged in the reagent injection part 131 of the reagent quantitative flow channel 15. The arrangement method of the first reagent 18, the second reagent 19, and the specimen 17 is not limited. For example, holes are opened at positions corresponding to the sample injection unit 111 and the reagent injection unit 131 in the sheets 291 and 292, and the user injects the sample 17, the first reagent 18, and the second reagent 19 from the holes, You may seal and seal. In addition, the first reagent 18 and the second reagent 19 may be arranged in advance in the respective reagent injection portions 131 of the reagent quantitative flow paths 13 and 15 and sealed with sheets 291 and 292. In this case, a hole may be opened in the sheet 291 at a position corresponding to the sample injection part 111 of the sample fixed amount flow channel 11, and the user may inject the sample 17 from the hole, and further seal and seal. In addition, the volume V0 that is a predetermined injection amount of the first reagent 18 is determined, for example, by a user injecting a predetermined volume V0 into the reagent injection unit 131 using a pipette. The injection amounts of the second reagent 19 and the specimen 17 are also determined, for example, by the user injecting a predetermined volume into the reagent injection part 131 and the specimen injection part 111 using a pipette.

  The user attaches the inspection chip 2 to the mounting holder 61 and inputs a process start command from the operation unit 94. As a result, the CPU 91 executes the centrifugal process shown in FIG. 6 based on the control program stored in the ROM 93. The inspection apparatus 1 can inspect two inspection chips 2 at the same time. For convenience of explanation, a procedure for inspecting one inspection chip 2 will be described below. In the following description, the steady state of the inspection chip 2 shown in FIGS. 2 and 3 is referred to as a rotation angle of 0 degree, and the state rotated 90 degrees counterclockwise from the steady state is referred to as a rotation angle of 90 degrees. In the following description, when the CPU 91 rotates the inspection chip 2 from 0 degree to 90 degrees, the inspection chip 2 rotates counterclockwise as viewed from the front. Further, when the CPU 91 rotates the inspection chip 2 from 90 degrees to 90 degrees, the inspection chip 2 rotates clockwise as viewed from the front.

  As shown in FIG. 6, the CPU 91 reads motor drive information stored in advance in the HDD 95, sets drive information of the spindle motor 35 in the revolution controller 97, and sets drive information of the stepping motor 51 in the rotation controller 98. (S1). At this time, the test chip 2 is in a steady state and has a rotation angle of 0 degree as shown in FIGS. Next, the CPU 91 shown in FIG. 1 controls the revolution controller 97 to start driving the spindle motor 35 (S2). As a result, the inspection chip 2 having a rotation angle of 0 degrees revolves. The spindle motor 35 increases the rotation speed of the turntable 33 to the speed V based on an instruction from the revolution controller 97. The speed V is, for example, 3000 rpm. When the turntable 33 is rotated at this speed V, a centrifugal force F of several hundred G acts on the inspection chip 2. The CPU 91 maintains the rotation speed of the spindle motor 35 at the speed V (S3). As shown in FIG. 7A, a centrifugal force F acts on the test chip 2 from the left side 23 toward the right side 22. The reagent 16 moves from the reagent injection part 131 to the first holding part 132 by the action of the centrifugal force F. Further, the sample 17 moves from the sample injection unit 111 to the first sample holding unit 112. In the following description, the rotation speed of the turntable 33 is assumed to be constant at the speed V, but the value of the speed V may be changed during the centrifugal process.

  Next, the CPU 91 controls the rotation controller 98 to drive and control the stepping motor 51 to rotate the inspection chip 2 to a rotation angle of 90 degrees as shown in FIG. 7C (S4). FIG. 7C shows a state in which the inspection chip 2 has been rotated to a rotation angle of 90 degrees, and FIG. 7B shows an intermediate state during the rotation of the inspection chip 2 from the rotation angle of 0 degrees to 90 degrees of rotation. This is a state similar to that shown in FIG. In the state shown in FIG. 7C, the inspection chip 2 is rotated up to 90 degrees, and the centrifugal force F acts on the inspection chip 2 from the upper side portion 21 toward the lower side portion 24. By the action of the centrifugal force F, the reagent 16 flows from the first holding part 132 to the reagent quantifying part 134 through the second holding part 133 that is a bent wall surface. The excess reagent 16 in the reagent quantitative unit 134 flows to the reagent surplus unit 136 via the second guide unit 137. The centrifugal force F acts in a direction perpendicular to the reagent fixed amount surface 146. Thereby, the reagent 16 for the capacity of the reagent quantification unit 134 is quantified. In addition, the sample 17 flows from the first sample holding unit 112 to the separation unit 124 via the sample guide unit 113. The excess specimen 17 in the separation unit 124 flows to the specimen surplus part 126 via the passage 125. Therefore, the sample 17 corresponding to the volume of the separation unit 124 remains in the separation unit 124. The capacity of the separation part 124 is the capacity of the liquid flow path 25 below the fifth virtual plane 148 extending in the right direction from the end part 147 on the passage 125 side in the separation part 124 shown in FIG.

  Next, referring to FIG. 7B, the first reagent 18 during the rotation of the test chip 2 from the rotation angle 0 degree shown in FIG. 7A to the rotation angle 90 degree shown in FIG. The flow will be described. As shown in FIG. 7B, while the test chip 2 is rotated from the rotation angle 0 degree to the rotation angle 90 degrees, the first reagent 18 is transferred from the first holding part 132 to the second holding part 133. Flows in. Since the second holding unit 133 is a bent wall surface, the first reagent 18 flows from the second holding unit 133 into the reagent quantitative unit 134 without storing the first reagent 18.

  The CPU 91 maintains the rotation speed of the spindle motor 35 at the speed V for a predetermined time (S5). Accordingly, the centrifugal force F acts from the upper side portion 21 toward the lower side portion 24 for a predetermined time on the inspection chip 2 having a rotation angle of 90 degrees shown in FIG. As a result, as shown in FIG. 8A, in the separation unit 124, the component of the specimen 17 is separated into the separation component 17A and the residual component 17B. For example, when the specimen 17 is blood, blood cells having a large specific gravity accumulate on the side in which the centrifugal force F acts, and plasma having a small specific gravity accumulates on the side opposite to the direction in which the centrifugal force F acts. That is, the residual component 17B that is blood cells in the blood and the separation component 17A that is plasma are separated.

  Next, the CPU 91 controls the rotation controller 98 to drive and control the stepping motor 51 to rotate the inspection chip 2 to a rotation angle of 0 degrees as shown in FIG. 8B (S6). As a result, the centrifugal force F acts on the test chip 2 from the left side 23 toward the right side 22.

  When the posture of the test chip 2 changes to the state shown in FIG. 8B, the first reagent 18 quantified in the reagent quantification unit 134 moves to the mixing unit 80 and is stored. The second reagent 19 quantified in the reagent quantification unit 134B moves to the reagent receiving unit 341. Further, the separation component 17A moves to the second specimen holding unit 123 through the passage 127. As shown in FIG. 8C, the separated component 17A remaining in the separation unit 124 and a part of the residual component 17B move to the component holding unit 121 via the connection channel 120.

  Next, the CPU 91 controls the rotation controller 98 to drive and control the stepping motor 51 to rotate the inspection chip 2 to a rotation angle of 90 degrees as shown in FIG. 9A (S7). As a result, as shown in FIG. 9B, the centrifugal force F <b> 1 acts from the upper side portion 21 toward the lower side portion 24. Due to the action of the centrifugal force F1, the separated component 17A flows from the second sample holding unit 123 to the sample quantifying unit 114. Further, the second reagent 19 moves from the reagent receiving part 341 to the reagent receiving part 342. As shown in FIG. 9B, the excess separated component 17A in the specimen quantification unit 114 flows to the second surplus portion 116 via the separated component second guide unit 115. The centrifugal force F acts in a direction perpendicular to the specimen quantification surface 129. As a result, the separation component 17A corresponding to the volume of the specimen quantification unit 114 is quantified. Further, the second reagent 19 that has moved to the reagent receiving part 342 joins the first connection channel 301 formed in the front surface 201 via the joining hole part 351.

  Next, the CPU 91 controls the rotation controller 98 to drive and control the stepping motor 51. As shown in FIG. 9C, FIG. 10A, and FIG. Is rotated (S8). As a result, the centrifugal force F acts on the test chip 2 from the left side 23 toward the right side 22.

  As the centrifugal force F acts in the process of changing the posture of the test chip 2 from the state shown in FIG. 9B to the state shown in FIG. 10B, as shown in FIG. The separated component 17A quantified by the sample quantification unit 114 flows into the first reagent 18 stored in the first reagent 18, and is mixed to generate a mixed liquid 261. Next, the second reagent 19 that has joined from the joining hole portion 351 flows into the mixing portion 80 and a second mixed liquid 262 is generated as shown in FIG.

  Next, the CPU 91 controls the rotation controller 98 to drive and control the stepping motor 51 to rotate the inspection chip 2 to a rotation angle of 90 degrees as shown in FIG. 10C (S9). As a result, the centrifugal force F acts on the test chip 2 from the upper side portion 21 toward the lower side portion 24. Due to the action of the centrifugal force F, the second mixed liquid 262 moves to the measuring unit 81.

  Although not shown in FIG. 10, after S9 is executed, the CPU 91 controls the rotation controller 98 to drive the stepping motor 51. The CPU 91 rotates the inspection chip 2 until the rotation angle is 0 degree (S10). Further, the CPU 91 controls the revolution controller 97 to stop the rotation of the spindle motor 35 (S10). Therefore, the revolution of the inspection chip 2 is completed. Centrifugation is terminated.

  After execution of the centrifugal process, the CPU 91 controls the revolution controller 97 to rotate and move the inspection chip 2 to the angle of the measurement position. When the measurement controller 99 shown in FIG. 1 causes the light source 71 to emit light, the measurement light passes through the second mixed liquid 262 stored in the measurement unit 81. The CPU 91 performs optical measurement of the second liquid mixture 262 based on the change amount of the measurement light received by the optical sensor 72, and acquires measurement data. CPU91 calculates the measurement result of the 2nd liquid mixture 262 based on the acquired measurement data. The inspection result of the second mixed liquid 262 based on the measurement result is displayed on the display 96 shown in FIG. In addition, the measuring method of the 2nd liquid mixture 262 is not restricted to an optical measurement, Another method may be sufficient.

  In the above embodiment, the reagent injection part 131 is an example of the “injection part” of the present invention. The first reagent 18 and the second reagent 19 are examples of the “reagent” in the present invention. The reagent quantitative unit 134 is an example of the “quantitative unit” in the present invention. The reagent quantitative unit 134B is an example of the “quantitative unit” in the present invention. The separation component 17A is an example of the “specimen” in the present invention.

  As described above, in the test chip 2 and the test system 3 of the above embodiment, the possibility of air remaining in the quantification unit can be reduced and the quantification accuracy of the specimen or reagent can be improved.

  In addition, this invention is not limited to said embodiment, A various change is possible. For example, the first reagent 18 may be changed to a specimen. In addition, the measurement unit 81 is a lower part of the mixing unit 80, but may be provided separately from the mixing unit 80.

  In addition, the reagent fixed amount flow channel 15 and the second connection flow channel 331 are formed on the rear surface 202 side, and the reagent fixed amount flow channel 13 and the first connection flow channel 301 are formed on the front surface 201. However, the present invention is not limited to this. . For example, the reagent fixed amount flow path 15, the second connection flow path 331, the reagent fixed amount flow path 13, and the first connection flow path 301 may be formed on the front surface 201. In this case, the first connection flow path 301 and the second connection flow path 331 may join at the flow path of the front surface 201 instead of joining at the joining hole portion 351. Further, the reagent quantitative flow channel 15 and the second connection flow channel 331 may not be provided in the test chip 2. In this embodiment, the reagent quantification unit 134 is a quantification unit that quantifies the reagent, but may be used as a sample quantification unit. Moreover, the 2nd holding | maintenance part 133 may be formed from a recessed part instead of a bending wall surface.

  In the inspection chip 2, a ridge line slightly raised from the flow path may be formed in the reagent injection part 131. The volume surrounded by the ridgeline and the wall surface forming the reagent injection part 131 may be a volume V0 of a predetermined injection amount into the reagent injection part 131. In this case, it can be clearly seen how far the first reagent 18 (16) is injected into the reagent injection part 131 to reach the volume V0.

DESCRIPTION OF SYMBOLS 1 Test | inspection apparatus 2 Test | inspection chip 3 Test | inspection system 17 Specimen 17A Separation component 18 1st reagent 19 2nd reagent 114 Specimen fixed amount part 123 2nd specimen holding | maintenance part 123A 1st wall surface 123B Vertical wall surface 123C Wall part 123D Tip part 123K 1st virtual surface 128 Sample guide part 131 Reagent injection part 132 First holding part 132A First wall surface 132B Vertical wall surface 132C First wall part 132D Tip part 132K First virtual surface 133 Second holding part 133A First wall surface 133B Second wall surface 133K First virtual Surface 134 Reagent determination unit 139 Reagent guide unit

Claims (6)

An injection part into which a specimen or a reagent is formed, which is formed from a recess opened in the injection port direction provided on the upper side part of the plate member having a predetermined thickness ;
A quantification unit formed from a recess opened toward the upper side below the injection unit, and the sample or the reagent is quantified,
Said Oite between injection unit and the quantitative portion, is formed from a recess that is open in a direction crossing the opening direction of the injection unit, the holding unit that holds the specimen or the reagent,
A first wall surface that is a wall surface of the holding portion extended in the direction of the fixed amount portion in the holding portion ;
A mixing unit that is formed downstream of the quantification unit and that flows in the sample or the reagent quantified by the quantification unit;
A first guide part that is formed in the mixing part direction and the upper side part direction from the first end part that is one end part on the mixing part side of the quantifying part, and the sample or the reagent quantified in the quantifying part moves. When,
The specimen or the reagent overflowing from the quantification part is formed in a direction opposite to the mixing part and in a direction opposite to the upper side part from the second end which is an end opposite to the mixing part of the quantification part. A second guide that moves;
Including a flow path including
Predetermined injection amount of said reagent to said injection unit, or separated by the separation unit for separating the specimen, outflow of the sample after separation of flowing out of the separation unit, the opening direction of the injection unit A first virtual surface extending in a direction of an angle α from the tip of the first wall surface with respect to a direction parallel to the communication direction of the injection portion and the holding portion, which is a direction intersecting with the first portion, and the first wall surface Are connected and the volume formed by the wall surface forming the holding portion is equal,
The angle α is larger than an angle β formed by the first wall surface with respect to a direction parallel to the communication direction, and
The first imaginary line, which is a straight line that passes through the first tip of the holding unit and flows out from the holding unit toward the quantification unit and is perpendicular to the first virtual plane, is the second end. Further, the inspection chip passes through the first end portion side. As the quantification unit , a reagent quantification channel which is the channel including a reagent quantification unit for quantifying the reagent, and
As the quantification unit , a sample quantification channel, which is the channel including a sample quantification unit for quantifying the sample ,
A test chip Ru comprising respectively,
The quantitative amount of the reagent quantitative part is larger than the quantitative quantity of the sample quantitative part,
In prior Symbol solution quantitative flow path, said first imaginary line passing through the reagent quantitation section,
In prior Symbol analyte quantitative flow path, said first imaginary line passing through the first guide portion side than the first end,
And the angle in the first guide portion is less than 90 degrees among the angles formed by the first virtual wall and the first guide wall surface forming the first guide portion and connected to the first end portion. The inspection chip according to claim 1. When the quantification unit is a sample quantification unit that quantifies the sample, an angle β1 formed by the first wall surface with respect to a direction parallel to the communication direction is determined by the reagent quantification unit in which the quantification unit quantifies the reagent. The first wall surface is smaller than an angle β2 formed with respect to a direction parallel to the communication direction,
The ratio of the quantitative amount of the sample quantification unit to the outflow amount of the sample after flowing out from the separation unit is the quantification of the reagent quantification unit with respect to the predetermined injection amount of the reagent to the injection unit. The inspection chip according to claim 1, wherein the inspection chip is larger than a ratio of the amounts. A test chip according to any one of claims 1 to 3, the test chip is held and revolved to apply a centrifugal force to the test chip, and the test chip is rotated to change the direction in which the centrifugal force is applied. An inspection system comprising a changing inspection device,
The inspection chip is
In the case where the quantification unit is a sample quantification unit that quantifies the sample, the opening width of the sample guide unit that guides the sample from the holding unit to the sample quantification unit is narrower than the opening width of the sample quantification unit,
When the quantifying unit is a reagent quantifying unit that quantifies the reagent, the opening width of the reagent guiding unit that guides the reagent from the holding unit to the reagent quantifying unit is formed wider than the opening width of the sample guiding unit. And
The inspection device includes:
An inspection chip holding section for holding the inspection chip;
A first rotating device that revolves the test chip holding portion around a first axis and applies a centrifugal force to the test chip;
A second rotating device that rotates the inspection chip holding portion around a second axis intersecting the first axis, and changes a direction of the centrifugal force applied to the inspection chip;
A control device for controlling the first rotating device and the second rotating device;
In the storage device of the control device,
Viscosity of the specimen μ,
A flow path length L of the specimen guide unit;
A cross-sectional area S of the flow path of the specimen guide unit;
The mass m of the specimen injected into the specimen quantification unit,
Gravity acceleration g,
An acute angle θ that is connected to the second end portion of the fixed amount portion and that forms an inclined surface that constitutes the second guide portion with respect to a direction parallel to the communication direction,
An opening width d2 of the first end portion and the second end portion of the fixed amount portion;
The depth w of the quantification part,
Surface tension T of the specimen,
And the contact angle δ of the sample liquid is stored in advance,
The controller is
When the specimen is injected into the specimen quantification unit, the second rotating device is controlled,
The centrifugal force is in the order of a first centrifugal direction that is perpendicular to the first virtual plane, a second centrifugal direction that is perpendicular to the first wall surface, and a third centrifugal direction that is perpendicular to the quantitative surface. An angle changing rotation is performed to rotate the inspection chip around the second axis so that
When the time for changing the direction in which the centrifugal force is applied from the first centrifugal direction to the second centrifugal direction, which is an injection time related to the injection of the sample into the sample quantitative unit, is t.
The magnitude of the first centrifugal force applied in the first centrifugal direction and the second centrifugal direction is:
The revolution speed of the inspection chip by the first rotating device is controlled to be larger than 32 × μ × L ² / (S × t × m × g),
Thereafter, the magnitude of the second centrifugal force applied in the third centrifugal direction is:
(2 × (d2 + w) × T × cos δ × cos θ / cos (90−θ)) + 1
An inspection system for controlling a revolution speed of the inspection chip by the first rotating device so as to be larger. In the storage device,
An acute angle θ ′ that is connected to the second end portion of the fixed amount portion and that forms an inclined surface that constitutes the second guide portion with respect to a direction parallel to the communication direction,
An opening width d2 ′ of the first end portion and the second end portion of the quantitative portion,
The depth w ′ of the quantitative portion,
Surface tension T ′ of the reagent,
And the contact angle δ ′ of the reagent liquid is stored in advance,
When the reagent is injected into the reagent quantification unit, the control device causes a third centrifugal force different from the first centrifugal force to act in the first centrifugal direction and the second centrifugal direction, and Controlling the first rotating device and the second rotating device so that the second centrifugal force greater than the three centrifugal force acts on the test chip in the centrifugal direction;
The second centrifugal force is
(2 × (d2 ′ + w ′) × T ′ × cos δ ′ × cos θ ′ / cos (90−θ ′)) + 1
The inspection system according to claim 4, wherein the revolution speed of the inspection chip by the first rotating device is controlled to be larger. The length of the second imaginary line extending from the portion where the second imaginary plane parallel to the first imaginary plane is in contact with the bottom of the reagent quantitative unit to the second end is Lm ′,
The length of the second imaginary line extending from the portion where the second virtual plane parallel to the first virtual plane is in contact with the bottom of the sample quantitative section to the end of the second sample quantitative section is Lm,
The centrifugal force applied to the inspection chip during the time t1 from when the first centrifugal force is applied in the first centrifugal direction to when the first centrifugal force is applied in the second centrifugal direction is In the case of F1,
When the reagent is injected into the reagent quantitative unit,
Time t1 is

So that
When the sample is injected into the sample quantification unit,
Time t1 is

The inspection system according to claim 5, wherein the control device controls the first rotating device and the second rotating device.

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