JP2003329696A - Chemiluminescence enzyme immunoassay device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a chemiluminescence enzyme immunoassay device with a compact and simplified configuration on the whole, possible in high sensitivity measurement, needing a short time in immunoreaction, and capable of measuring a large amount of specimens efficiently. <P>SOLUTION: A plurality of stages having incubation function are formed on the upper surface of a turn table 18 circular in plane view. Each stage houses specimens, magnetic particles, reagents and washing liquids necessary for immunoreaction, etc., with a plurality of cartridges 14 with a plurality of wells formed positioned freely detachably in such a way that the outside edge of each cartridge 14 lies on an arc in the same curvature radius as that of the outer circumference of the turn table 18, a dispenser unit 32 equipped with a plurality of dispensers 43, provided corresponding to the plurality of cartridges 14 respectively, is provided straightly movably, and the dispensers 43 are arranged on an arc in the same curvature radius as that of the outer circumference of the turn table. <P>COPYRIGHT: (C)2004,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a chemiluminescent enzyme immunoassay device used for detecting and measuring biological substances and environmental addition substances such as endocrine disrupters.
Particle size 0.3-5.0 μm with antigen or antibody solid phase on the surface
The present invention relates to a chemiluminescent enzyme immunoassay device using the magnetic fine particles (hereinafter referred to as magnetic fine particles).

[0002]

2. Description of the Related Art As a conventional example of the chemiluminescent enzyme immunoassay device, there are those described in, for example, JP-A-5-287001 and JP-A-6-324042. In the chemiluminescent enzyme immunoassay devices in these publications, it is necessary to transport the reagent cartridge to a mechanical unit (for example, a dispensing / dispensing nozzle, a washing device) or a reagent storage required for the reaction process step, and therefore the device is used. The structure is complicated. In addition, the structure of the chemiluminescence measurement unit is independent of the reaction container or reagent cartridge, and the reaction solution is dispensed and dispensed into the chemiluminescence measurement unit, or the cartridge containing the measurement cell is used as the chemiluminescence measurement unit. A mechanism to move it was necessary.

[0003]

As a means for solving the above-mentioned inconvenience, there is, for example, a chemiluminescent enzyme immunoassay device described in JP-A-8-211071. In the chemiluminescent enzyme immunoassay device of this publication, the cartridge container can be phased not only at the dispensing position and the measuring position but also at the reading position, so that the sample dispensing and diluting work and the dispensing of the reagent and the washing liquid can be performed. Since work and measurement work can be performed automatically and reliably and easily without human intervention, the burden on the operator (operator) can be reduced and reliable measurement can be performed. it can.

In the chemiluminescent enzyme immunoassay device disclosed in Japanese Patent Laid-Open No. 8-211071, the inconvenience of the chemiluminescent enzyme immunoassay device before that is considerably improved, but a large amount of sample is processed in a short time. In terms of aspects, there were some points left to be improved.

The present invention has been made in view of the above matters, and its purpose is to shorten the time required for an immune reaction,
Compact and high-sensitivity measurement with simplified overall configuration,
Moreover, it is to provide a chemiluminescent enzyme immunoassay device capable of efficiently measuring a large amount of specimens.

[0006]

In order to achieve the above object, the present invention provides a chemiluminescent enzyme immunoassay apparatus using magnetic fine particles having an antigen or an antibody solid phase on the surface thereof, and an upper surface of a circular turntable in plan view. A plurality of stages having an incubation function are formed in each stage, and each stage contains liquids such as a specimen, magnetic fine particles, reagents necessary for an immune reaction, and a washing solution, and a plurality of wells for performing a predetermined immune reaction are formed. The plurality of cartridges are detachably mounted and positioned so that the outer end surfaces of the respective cartridges are lined up in an arc having a radius of curvature equal to the radius of curvature of the outer circumference of the turntable, while being set on one stage. It is equipped with multiple dispensers that are provided to correspond to multiple cartridges and have a function of attracting and retaining magnetic particles. And a plurality of dispensers each having a radius of curvature equal to the radius of curvature of the outer circumference of the turntable. They are arranged so as to line up on an arc (claim 1). As the dispenser having the function of attracting and retaining magnetic particles, for example, the device disclosed in Japanese Patent No. 3115501 is preferable.

In the chemiluminescent enzyme immunoassay device having the above-mentioned structure, the cartridge transport mechanism, the reagent storage, the reagent dispensing mechanism, etc. are not required, and the structure is simplified and the entire device is small and compact. That is, since a plurality of dispensers having a magnetic fine particle adsorption / holding function are provided so as to correspond to a plurality of cartridges set on one stage, respectively, it is possible to simultaneously perform an immune reaction of a plurality of specimens, Even if the amount of the sample is large, the measurement can be performed efficiently in a short time. Further, since the plurality of cartridges and the plurality of dispensers corresponding to these cartridges are respectively arranged so as to be arranged on an arc having a radius of curvature equal to the radius of curvature of the outer circumference of the turntable, it is possible to improve the space factor. In addition, the structure of the photodetector is simplified.

In the cartridge, since the bottom of the well is sharpened, the efficiency of capturing the magnetic fine particles is improved. In addition, since the shape and size of the wells are set so that the height of the liquid surface when containing the liquid is the same in all wells, the thickness of the air layer becomes constant, and A mechanism for detecting the position of the liquid surface at is unnecessary. Further, a luminescence substrate injection part for injecting a luminescence substrate, a chemiluminescence measurement part for measuring chemiluminescence generated in the measurement well, an arithmetic control part for controlling each part of the device and processing a signal from the chemiluminescence measurement part. Since it is equipped with, it is possible to automatically measure the immune reaction including the injection of the luminescent substrate.

[0009]

DETAILED DESCRIPTION OF THE INVENTION The details of the present invention will be described below with reference to the drawings. 1 to 11 show a first embodiment of the present invention.
An embodiment of is shown. First, in FIGS. 1 to 3, reference numeral 1 denotes a case of a measuring device, which includes a lower case 2 and an upper case 3 detachably attached to the lower case 2. And
The front side of the lower case 2 (arrow F in FIGS. 1 and 3)
An operation panel section 6 including various operation key sections 4 and a display section 5 is formed in the center (on the side indicated by). A printer 7 is built in the right side portion of the operation panel 6 of the lower case 2, and a bottle 8 containing a luminescent substrate as a reagent can be stored in the left side portion.

An opening 9 of an appropriate size is formed in the center of the front surface of the upper case 3, and the opening 9 is opened and closed by a door 11 which rotates in a vertical direction about a hinge portion 10. A card drive 13 for setting the memory card 12 in which the measurement procedure is recorded is formed at an appropriate location on the upper case 3.

Before describing the detailed structure of the inside of the case 1, the cartridge used in the present invention will be described with reference to FIGS. 8 and 9. This cartridge is a container for accommodating a specimen, magnetic fine particles, a reagent necessary for an immune reaction, a washing solution, and the like, and for performing a predetermined immune reaction. That is, in FIGS. 8 and 9, 14 is a cartridge, in which a plurality (for example, 11) of wells (small depressions) 15a to 15k are formed in a straight line. Wells 15b to 1 excluding the measurement well 15a
5k has a spindle-shaped inner bottom portion so that desired reagents and magnetic fine particles can be efficiently collected.
The bottom edge is sharp. The cartridge 14 is made of a resin having appropriate heat resistance and chemical resistance (for example, polyethylene or polystyrene). In this embodiment, 15b is a well containing a sample,
c is a well containing a diluent, 15d is a well containing magnetic fine particles, 15e, 15g, 15i, 15k are wells containing a washing solution, 15f is a well containing a labeling reagent, and 15h is a luminescent substrate. Well, 15
j is used as a reaction well.

The measuring well 15a has a double mouth so that the reagent does not leak during the supply of a luminescent substrate, which will be described later, and the light during chemiluminescence measurement does not leak outside. Is configured. As shown in FIG. 9, the cartridge 14 contains a predetermined amount of magnetic fine particles, a reagent necessary for an immune reaction, and a cleaning liquid in predetermined wells 15c to 15k. Their shapes and sizes are set so that the heights are the same in all wells. The wells 15c to 15k accommodating reagents and the like are sealed with a sealing member 16 such as an aluminum film with a heat-sealing agent. Reference numeral 17 is a confirmation bar code attached to an appropriate portion of the cartridge 14, for example, a flat surface adjacent to the measurement well 15a, and shows the content of measurement and the like.

Next, a detailed internal structure of the case 1 will be described with reference to FIGS. 1 to 7 and 9. First, 18 is a turntable having a circular shape in a plan view, which is provided substantially in the center of the lower part of the case 1. A circumferential side surface 19 of the turntable meshes with a gear 21 provided on an output shaft of a stepping motor 20, and a rotary shaft 22 is centered. And rotates in either direction of arrows A and B (see FIG. 1). In addition, 23 is a bearing of the rotating shaft 22. Also, the rotation position of the turntable 18 is
As shown in FIG. 2, a rotational position detecting device 2 including a light shielding plate 24 of an appropriate shape provided below the turntable 18 and a photo interrupter 25 provided in the lower case 2.
Detected by 6.

Reference numeral 27 designates a plurality of stages formed on the upper surface side of the turntable 18, and for example, as shown in FIGS. 3, 5, and 6, five stages are provided so as to divide the circumference into five equal parts. Then, each of these stages 27 makes a plurality (for example, five) of cartridges 14 parallel to each other in the circumferential direction from the center of the turntable 18, and
The outer end surface of one cartridge 14 is the turntable 1
8 are arranged in an arc having a radius of curvature equal to the radius of curvature of 8 so that they can be detachably held.

That is, the five cartridges 14 in each stage 27 are provided so that their outer end surfaces are in contact with an arc indicated by reference numeral 14a in FIG. 6, and the radius of curvature 14r of the arc 14a is the turntable 18a. It is set to be equal to the radius of curvature of. Therefore, the five cartridges 1 in each stage 27
4 is provided along the outer periphery of the turntable 18. A heater (not shown) is built in the turntable 18 so that it can be incubated by controlling the temperature.

A chip holder 28 is provided so as to correspond to each of the five cartridges 14 set on each stage 27. The chip holder 28 has a disposable chip (hereinafter simply referred to as a chip) 2
9 are accommodated. This chip 29 is made of a material having appropriate heat resistance and chemical resistance, such as fluororesin or polypropylene resin, and as shown in FIGS. 4 and 9, the finest part 29a inserted into the wells 15a to 15k.
And an intermediate portion 29b which is thicker in a tapered shape above the finest portion 29a and a large diameter portion 29c above the intermediate portion 29b. A mounting portion 44 of a dispenser 43 described later can be detachably attached to the large diameter portion 29c. Inserted and held by this.

Reference numeral 30 denotes a cover body slidably provided above the turntable 18 on the front surface side of the case 1, and the five cartridges 14 set on one stage 27 and the chip 2 held by the chip holder 28.
The long hole 31 is formed so as to correspond to the number 9. That is, the cartridge 14 held on each stage 27 of the turntable 18 is subjected to various accesses by the dispenser unit 32, which will be described later, at the portion where the cover body 30 is formed. Further, the cover body 30 is
It is possible to prevent the cartridge 14 from floating upward when the chip 29 is attached to or detached from the chip holder 28, and to prevent the displacement of the cartridge 14, and to prevent the wells 15a to
It has a function of preventing foreign matter such as dust from entering the liquid within 15k and preventing the liquid from evaporating.

Reference numeral 32 denotes a dispenser unit provided above the turntable 18, which is independent of the turntable 18 and linearly moves between the center of rotation of the turntable 18 and the front side of the apparatus to form a cover 30. Various accesses are made to the cartridge 14 provided on the stage 27 which is located below, and is configured as follows, for example.

That is, in FIG. 3 and FIG.
Is a slide base, and both left and right sides of the pillar member 3 are erected on the front side F and the rear side R of the lower case 2.
It is provided so as to be guided by the two left and right guide rods 36 that are bridged over the cables 4, 35. The slide base 33 is provided with a coupling portion 37 on one side portion (on the right side in FIG. 3) of the slide base 33. The coupling portion 37 is moved forward and backward of the device by a stepping motor 38 provided on the front side F of the device, for example. It is connected to an endless belt 39 extending so as to be driven in the direction. That is, the slide base 33 is configured to move linearly between the center side of the turntable 18 and the front side F (see thick double arrow in FIG. 6). 3 and 6, reference numeral 40 is a drive pulley on the side of the stepping motor 38, and 41 is a driven pulley that is appropriately provided on the back side of the apparatus.

2 and 4, reference numeral 42 denotes a frame vertically installed on the slide base 33. The frame 42 is provided on the stage 27 as shown in FIGS. 3 and 6. One cartridge 14
The five dispensers 43 respectively corresponding to 1 are provided on one arc 43a in the left-right direction. More specifically, the five dispensers 43 are designated by the reference numeral 43 in FIG.
It is provided on the arc indicated by a, and this arc 43
The curvature radius 43r of a is set to be equal to the curvature radius of the turntable 18. That is, the five dispensers 43 are arranged with the same radius of curvature as the five cartridges 14 provided along the outer circumference of the turntable 18. Therefore, the five dispensers 43 can simultaneously access the respective cartridges 14 without moving the five cartridges 14 set on the stage 27.

At the lower end of each dispenser 43, a chip mounting portion 44 for mounting the chips 29 accommodated in the five chip holders 28 provided on the stage 27 is formed, and above the syringes from the syringe. A suction nozzle 45 is provided, which is configured to move in the vertical direction and to perform suction / discharge operations with the chip 29 mounted. Reference numeral 46 is an O-ring as a seal member provided in the chip mounting portion 44.

2 and 4, reference numeral 47 denotes a magnetic fine particle attracting arm having a permanent magnet 48 for attracting magnetic fine particles at its tip, which brings the permanent magnet 48 closer to the uppermost portion 29a of the chip 29. It is provided so that it can be moved in and out of it, and can be moved up and down as the dispenser 43 moves up and down.

Further, in FIGS. 2 and 4, reference numeral 49 is a seal breaker provided on the front surface side corresponding to each dispenser 43, and as shown in FIG. 9, it moves vertically to move wells 15c to 15k. The seal member 16 applied to the above is broken. In FIG. 4, 5
0 is a spring.

The five dispensers 43 of the dispenser unit 32 include three stepping motors 51-5.
3. The driving unit 61 including the screw shafts 54 to 56, the moving plates 57 to 60, etc., which are driven by them, is configured to simultaneously perform a predetermined operation.

In FIGS. 1, 3 and 7, reference numeral 62 denotes a luminescent substrate injection portion provided around the turntable 18, which is a pump 64 connected to the luminescent substrate bottle 8 by a tube 63, the pump 64 and the tube 65. The injection unit 66 is connected to the injection unit 66, and the luminescence substrate is injected into the measurement well 15a located below the injection unit 66 by the rotation of the turntable 18.

Then, in FIGS. 1, 3 and 7,
Reference numeral 67 denotes a chemiluminescence measuring unit for measuring chemiluminescence generated in the measurement well 15a, and a luminescence measuring unit 68 having a shutter (not shown), and an electronic image multiplier connected to the luminescence measuring unit 68 by an optical fiber 69. Measurement well 1 which is composed of a photodetector 70, etc., and which is located below the luminescence measurement unit 68 by rotation of the turntable 18.
Chemiluminescence generated in 5a is measured by a luminescence measuring unit 68.
Is measured, the light is transmitted to the photodetector 70 through the optical fiber 69, and the intensity of the chemiluminescence is detected by the photodetector 70.

The control of each part of the apparatus having the above-mentioned configuration and the calculation based on the output of the photodetector 70 are performed by a calculation control unit (not shown).

Next, the operation of the chemiluminescent enzyme immunoassay device will be described with reference to FIGS. 10 and 11. FIG. 10 schematically shows the flow of processing in the enzyme immunoassay of the one-step sandwich method, and FIG. 11 schematically shows the movement of the dispenser 43 in the analysis. The four forms a to d shown in the upper part of FIG. 11 are respectively suction of liquid, stirring of liquid, stirring of liquid in a state where magnetic fine particles are adsorbed,
The discharge of the liquid is shown.

The case where five cartridges 14 are set on one stage 27 located in front of the apparatus and the enzyme immunoassay of the one-step sandwich method is performed will be described below.

As shown in FIG. 11, the five cartridges 14 used for the measurement contain a sample, magnetic fine particles, a reagent necessary for an immune reaction, a washing solution, and the like. Of these, magnetic fine particles other than the sample are contained. The reagent and the washing solution are stored in a predetermined well in advance, and the upper opening of each well is sealed by the seal member 16. That is, FIG. 9 and FIG.
In the example shown in FIG.
A magnetic fine particle 72 is contained in the well 15d, a labeling reagent 73 is contained in the well 15f, and a cleaning liquid 74 is contained in the wells 15g, 15i, 15k, respectively, and they are sealed. The sample 75 is dispensed into the well 15b immediately before measurement using an appropriate dispensing tool 76 (see FIG. 9).

First, the stage 2 on the turntable 18
It is confirmed whether or not the cartridge 14 is mounted on the printer 7 (step S1 in FIG. 10, hereinafter, only step numbers will be described).

A predetermined number of cartridges 14 are mounted on the stage 27.
, The dispenser unit 32 is moved (advanced) in the direction of the stage 27, and the seal breaker 49 is repeatedly moved up and down.
Each of the seals d, 15f, 15g, 15i to 15k is broken (step S2).

Next, the suction nozzle 45 of the dispenser unit 32 is lowered, and the tip 29 held by the tip holder 28 is mounted on the mounting portion at the lower end thereof (step S).
3). As a result, for the five cartridges 14,
Five dispensers 43 are formed.

The chip 29 is moved to the sample well 15b,
The sample 75 in the well 15b is subjected to so-called co-washing in which suction and discharge are alternately performed and sufficiently stirred, and then a certain amount of the sample 75 is sucked, and in that state, the chip 29 is moved to the dilution well 15c. By this, sampling (step S4)
Is completed.

Specimen 7 held in the chip 29
5 is discharged into the diluting well 15c and stirred by co-washing to dilute the specimen 75 (step S5), and then a certain amount of the diluted specimen (diluted specimen) 75 is sucked, and the chip 29 is moved to the reaction well 15j. Move to.

Specimen 7 held in the chip 29
5 is discharged into the reaction well 15j, the empty chip 29 is moved to the well 15d, the magnetic fine particles 72 in this well 15d are agitated by co-washing, then the magnetic fine particles 72 are sucked, and in that state, the reaction well 15j The magnetic fine particles 72 held therein are discharged into the reaction well 15j.
Then, the sample 75 and the magnetic fine particles 72 are sufficiently stirred by performing the co-washing.

Then, the empty chip 29 is attached to the labeling well 15
After moving to f and stirring the labeling reagent 73 in this well 15f by co-washing, a certain amount is sucked, the chip 29 is moved to the reaction well 15j, and the labeling reagent 73 held therein is held.
Are discharged into the reaction well 15j. Then, the liquid in the well 15j (the sample 75 + the magnetic fine particles 72 + the labeling reagent 7
Stir 3) by co-washing. This completes the immune reaction pretreatment (step S6).

After the pretreatment of the immunoreaction, the reaction well 15
In j, an immune reaction is performed. In this case, the reaction well 15j is temperature-controlled by the heater so that the stage 27 on which the cartridge 14 including the reaction well 15 is set is heated to an appropriate temperature, so that the desired immunoincubation (step S7) is suitably performed. As a result, an immune reaction is favorably performed in the reaction well 15j. This immune reaction is performed over 930 seconds, for example.

When the predetermined immunoincubation is completed, the empty chip 29 agitates the liquid in the reaction well 15j by co-washing and then sucks a fixed amount of the liquid. Then, the magnetic fine particle adsorption arm 47 is operated to bring the permanent magnet 48 into contact with the upper side of the finest portion 29a of the chip 29, and the specimen 7
5 and the magnetic fine particles 72 that have reacted with the labeling reagent 73 are captured on the inner side of the finest portion 29a of the chip 29 (the magnetic fine particles 72 are adsorbed on the inner side of the chip 29 by magnetic force), and the reaction liquid is collected (step S8). .

Chip 29 adsorbing the magnetic fine particles 72
Is moved to the washing well 15k, and the washing liquid 74 in this well 15k is sucked. And the magnetic fine particle adsorption arm 4
7 is operated to separate the permanent magnet 48 from the side surface of the chip 29, and the magnetic fine particles 72 are washed by co-washing.
Adsorb.

Then, the chip 29 on which the magnetic fine particles 72 are adsorbed is sequentially moved to the washing wells 15i and 15g,
The magnetic fine particles 72 are washed by performing the same operation as in the washing well 15k. That is, in this embodiment, the magnetic fine particles 72 after the immune reaction are washed with the washing liquid 74 three times (step S9). Needless to say, the number of times of cleaning varies depending on the test item for the sample 75.

In this case, since the five cartridges 14 and the five dispensers 43 are arranged on the arcs having the same radius of curvature, the five dispensers 43 are arranged.
Can simultaneously access the respective cartridges 14 without moving the five cartridges 14. Therefore, the above steps S2 to
The processes up to step S9 can be simultaneously performed in parallel for the five cartridges 14 set on the stage 27.

In the state where the magnetic fine particles 72 after the cleaning process are held on the chip 29, the turntable 18 is held.
7 is rotated in the direction indicated by arrow A in FIG. 7 to move the stage 27 to the injection unit 66 (light emitting substrate injection position) of the light emitting substrate injection section 62. Then, by rotating the turntable 18 little by little, a fixed amount of the luminescent substrate is sequentially dispensed into the measurement wells 15a of the five cartridges 14 on the stage 27 (step S10). After the dispensing of the luminescent substrate, the turntable 18 is rotated in the direction indicated by the arrow B in FIG. 7 to return the stage 27 to the front position of the device again.

The chip 29 holding the magnetic fine particles 72 is
In that state, the measurement well 15a is moved to the well 1
A certain amount of the luminescent substrate in 5a is attracted, the permanent magnet 48 is separated from the side surface of the chip 29, the magnetic fine particles 72 are discharged into the measurement well 15a together with the luminescent substrate, and agitated by co-washing. This causes the luminescence reaction to start, but chemiluminescence starts a little after the luminescence reaction starts. Therefore, the turntable 18 is rotated in the direction indicated by the arrow A in FIG. 7, the stage 27 is moved to the chemiluminescence measuring unit 67, and the measurement wells 15a in which the luminescence reaction is performed are sequentially performed in the luminescence measuring unit 68 ( It moves to the luminescence observation position), transmits the light of chemiluminescence to the photodetector 70 through the luminescence measuring unit 68 and the optical fiber 69, and detects the intensity of chemiluminescence (step S11).

Then, the measurement wells 15a in the five cartridges 14 in which the luminescence reaction is performed are sequentially
When moving to the luminescence measurement unit 68 (light emission observation position), each cartridge 14 moves on the same circular arc, so that the cartridge having the positional relationship between the measurement well 15a and the luminescence measurement unit 68 in each cartridge 14 is determined. Since the measurement well 15a in 14 is always constant, the operation during measurement is simple.

The output value of the photodetector 70 is processed by a computer.

In the above embodiment, the five stages 27 are provided on the turntable 18, so that while the incubation is performed in one stage 27 as described above, the other four stages 27 are used. If the pretreatment is carried out at 27, or if the incubation time is short, the cartridge 14 is mounted on the stage 27, etc., whereby the measurement can be carried out efficiently.

In the above-described embodiment, the case where five cartridges 14 are set on one stage and the enzyme immunoassay of the one-step sandwich method is performed is taken up, but the present invention is not limited to this. Needless to say. For example, it can be similarly applied to the enzyme immunoassay of the two-step sandwich method. FIG. 12 schematically shows a processing flow in the enzyme immunoassay of this two-step sandwich method.

[0049]

According to the chemiluminescent enzyme immunoassay device of the present invention, the cartridge transporting mechanism, the reagent storage, the reagent dispensing mechanism, etc. are not required, the structure is simplified, and the entire device is small and compact. Needless to say, since a plurality of dispensers having a function of adsorbing and retaining magnetic particles are provided so as to correspond to a plurality of cartridges set on one stage, it is possible to simultaneously perform an immune reaction of a plurality of specimens. Therefore, even if the amount of the sample is large, the measurement can be performed efficiently in a short time.

Further, since the plurality of cartridges and the plurality of dispensers corresponding to the cartridges are arranged so as to be arranged on the same radius of curvature as the outer circumference of the turntable, the plurality of dispensers are set on the stage. It is possible to simultaneously access the corresponding cartridges without moving a plurality of cartridges that are installed, and each cartridge
By rotating the turntable, since it moves on the same arc, the positional relationship between the measurement well in each cartridge and the luminescence measurement unit is always constant for any measurement well in any cartridge,
The operation at the time of measurement is simple, and since it is not necessary to move the chemiluminescence measurement unit, the measurement accuracy does not decrease, the space factor is improved, and the structure of the chemiluminescence measurement unit is simple. Be converted.

In the cartridge, since the bottom of the well is sharpened, the efficiency of capturing the magnetic fine particles is improved. In addition, since the shape and size of the wells are set so that the height of the liquid surface when containing the liquid is the same in all wells, the thickness of the air layer becomes constant, and A mechanism for detecting the position of the liquid surface at is unnecessary. Further, it comprises a luminescence substrate injection part for injecting a luminescence substrate, a chemiluminescence measurement part for measuring chemiluminescence generated in the measurement well, and an arithmetic control part for controlling each part of the apparatus and processing a signal from the chemiluminescence measurement part. Therefore, the immune reaction can be automatically measured including the injection of the luminescent substrate.

Therefore, according to the present invention, it is possible to obtain a chemiluminescent enzyme immunoassay device capable of processing a large amount of specimens in a short time and capable of highly sensitive measurement.

[Brief description of drawings]

FIG. 1 is a view showing an example of a chemiluminescent enzyme immunoassay device of the present invention, which is a perspective view of an upper case seen through.

FIG. 2 is a vertical cross-sectional view showing a main part of the measuring device.

FIG. 3 is a diagram showing a planar configuration of the measuring apparatus.

FIG. 4 is a sectional view showing a dispenser unit and a turntable.

FIG. 5 is a plan view showing a state in which a cartridge is provided on the stage of the turntable.

FIG. 6 is a plan view schematically showing an arrangement state of cartridges and an arrangement state of dispensers on one stage of a turntable.

FIG. 7 is a perspective view schematically showing the configurations of a luminescence substrate injection part and a chemiluminescence measurement part.

FIG. 8 is a view showing an example of a cartridge, (A) is a plan view and (B) is a vertical sectional view.

FIG. 9 is a view for explaining the operation of the dispenser unit with respect to the cartridge.

FIG. 10 is a diagram schematically showing a processing flow in enzyme immunoassay of the one-step sandwich method.

FIG. 11 is a diagram for explaining the operation of the chip with respect to the cartridge in the enzyme immunoassay.

FIG. 12 is a diagram schematically showing a process flow in enzyme immunoassay of a two-step sandwich method.

[Explanation of symbols]

14 ... Cartridge, 15a to 15k ... Well, 18 ...
Turntable, 27 ... Stage, 32 ... Dispenser unit, 43 ... Dispenser, 62 ... Luminescent substrate injection part, 67 ... Chemiluminescence measurement part, 72 ... Magnetic fine particles, 73 ...
Reagent, 74 ... Washing liquid, 75 ... Specimen.

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification symbol FI theme code (reference) G01N 35/06 B (72) Inventor Shuji Tajima 88 Uehongo, Matsudo-shi, Chiba Precision System Science Co., Ltd. In-house (72) Inventor, Hozumi Nakajima 88, Uehongo, Matsudo-shi, Chiba F-Term (Precision System Science Co., Ltd.) (reference) 2G058 AA09 BB15 CC03 CC17 CD05 CE05 CE08 EA11 ED02 ED19 GA01

Claims (3)

[Claims] 1. In a chemiluminescent enzyme immunoassay apparatus using magnetic fine particles having an antigen or an antibody solid phase on the surface thereof, a plurality of stages having an incubation function are formed on the upper surface of a turntable having a circular shape in plan view, and each stage comprises , A sample, magnetic microparticles, a reagent necessary for an immune reaction, a liquid such as a washing solution, and a plurality of wells for performing a predetermined immune reaction are detachably attached to the outside of each cartridge. End faces of the turntables are arranged so as to line up on an arc having a radius of curvature equal to the radius of curvature of the outer circumference of the turntable. Rotating the turntable with a dispenser unit equipped with a plurality of dispensers having a function of adsorbing and retaining particles. A linearly movable unit is provided between the center side and the front side of the device, and further, the plurality of dispensers are arranged so as to be arranged on an arc having a radius of curvature equal to the radius of curvature of the outer circumference of the turntable. Characterized chemiluminescent enzyme immunoassay device. 2. The cartridge has a plurality of wells whose bottoms are sharpened and whose shape and size are set so that the height of the liquid surface when containing the liquid is the same in all the wells. The chemiluminescent enzyme immunoassay device according to claim 1. 3. A luminescence substrate injection part for injecting a luminescence substrate into the liquid after the immunoreaction, which is provided in the measurement well of the cartridge, provided around the turntable, and a chemiluminescence measurement for measuring chemiluminescence generated in the measurement well. The chemiluminescent enzyme immunoassay device according to claim 1 or 2, further comprising: a unit and an arithmetic control unit that controls each unit of the device and processes a signal from the chemiluminescence measuring unit.