JPH05196625A - Immunity measuring method and device - Google Patents

Abstract

(57) [Summary] [Objective] To provide an immunoassay method and apparatus capable of measuring a value by a non-specific adsorption reaction by an ordinary analysis without performing pretreatment. A reaction detection container A having a solid phase carrier of fine-diameter granules 61, containing a solid phase reagent 62 having an antibody or an antigen immobilized on the surface of the solid phase carrier, and having a discharge hole at the bottom, and immobilizing the antibody or the antigen A reaction detection container B containing only a solid phase carrier 61 of small-diameter granules that does not solidify and having a discharge hole at the bottom is used, and the reaction detection containers A and B are set on a reaction turntable having a plurality of positions, and the sample antigen or The abnormal data is corrected by quantitatively measuring the amount of the antigen or antibody 63 in the sample by the immune reaction with the antibody. Therefore, it is possible to correct abnormal data by performing quantitative measurement of the amount of antigen or antibody of the same sample and comparing them without performing pretreatment on the sample, and a complicated operation for correcting abnormal data can be performed. Can be eliminated.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an immunoassay method and apparatus for measuring components contained in a sample such as serum or urine by an immunoreaction using a solid phase reagent.

[0002]

2. Description of the Related Art The enzyme immunoassay is a method for determining the level of an antigen-antibody reaction using enzyme activity as a marker and quantifying the amount of the antigen or the antibody. ), And the enzyme-labeled antibody (or antigen) is further reacted, or the enzyme-labeled antigen (or antibody) and unlabeled antigen (or antibody)
There are various methods such as a competitive reaction method in which the amount of the unlabeled antigen is obtained by competing with.

FIG. 5 is a diagram for explaining the principle of measurement by the sandwich method and the competitive method, 61 is a solid phase carrier, and 6 is a solid phase carrier.
2 is an antibody, 63 is an antigen to be measured, 64 is a labeled substance, 65 is a labeled antibody, 66 is a substrate, and 67 is a product.

In the sandwich method, as shown in FIG. 5 (a), first, the antibody 62 is immobilized on the surface of the solid-phase carrier 61 by physical adsorption or binding utilizing a chemical reaction, and then the antibody 62 is solidified. A sample containing the measurement antigen 63 is added (). As a result, an antigen-antibody reaction (first reaction) occurs, and the measured antigen 63 binds to the solid-phased antibody 62. Thereafter, washing is performed to discard the contaminating components in the sample ().

Next, an enzyme-labeled antibody 65 to which an enzyme is bound as a labeling substance 64 is added (). As a result, an antigen-antibody reaction (second reaction) occurs, and the enzyme-labeled antibody 65 binds to the antigen 63 bound to the immobilized antibody 62.
In this case, since the enzyme-labeled antibody 65 is added in excess, the free-form portion (free: free: not bound to the bound type portion (bound: B) generated by the binding of the antigen 63 and the antibody 65).
F) can be done (). Therefore, the excess enzyme-labeled antibody in the free portion (free: F) is discarded by washing ().

Next, an enzymatic reaction is carried out (). Since the enzyme activity at this time is determined by the amount of the enzyme-labeled antibody in the binding type portion, the amount of the enzyme-labeled antibody represents the amount of the antigen bound to the immobilized antibody, that is, the amount of the measured antigen. It will be.

In the competitive reaction method, as shown in FIG. 5B, the antibody is immobilized on a solid phase, and the antigen to be measured and a labeled antigen in which a label is bound to the same antigen as the antigen to be measured are added ( ). As a result, an antigen-antibody reaction occurs, and the antigen to be measured and the labeled antigen bind to the solid-phased antibody according to their respective amounts ().

Next, as in the above sandwich method, B / F
Separation and enzymatic reaction (,). Since the enzyme activity at this time is determined by the amount of the enzyme-labeled antibody in the binding type portion, the amount of the antigen to be measured can be determined from the amount of the labeled antigen added using a calibration curve.

When the above enzyme immunoassay is automated, a solid phase carrier such as polystyrene balls or glass beads on which an antibody or an antigen is immobilized is used as a solid phase reagent. Since this solid-phase reagent is unstable,
Normally, it is placed in a container filled with a preservative solution, and when performing enzyme immunoassay, one solid phase reagent is transferred from the container to the reaction detector, and sample dispensing, labeling reagent dispensing, B /
After performing F separation, washing, etc., the bonded portion is transferred to the detector.

[0010]

However, in the above-mentioned immunoassay, there is a problem that abnormal data is generated due to non-specific adsorption and it takes time to correct the abnormal data. FIG. 6 is a diagram for explaining a process for generating and correcting abnormal data due to non-specific adsorption.

Usually, when serum is used as a sample, FIG.
In addition to the measured component 63, various components 71 are contained as shown in FIG. Therefore, the abnormal data due to non-specific adsorption is, for example, that something 71 other than the antigen 63 to be measured is adsorbed on the solid phase carrier 61 or the wall of the container in the first reaction, and the enzyme-labeled antibody is bound to it in the second reaction. It is caused by.

Therefore, in order to determine whether abnormal data due to non-specific adsorption or whether the sample is actually high, a method of removing the component to be measured has been conventionally used as an inactivation process of the sample. .. This inactivation treatment removes the component to be measured using the components 72 and 73 for inactivating the component 63 to be measured in the sample as shown in FIG. 6B. When the immunoassay is similarly carried out for, as shown in FIG. 6 (c), it is possible to measure and quantify something other than the measured antigen 63 adsorbed on the solid phase carrier 61, the wall of the container or the like. Therefore, by comparing the value obtained by measuring the sample as it is with the value obtained by performing the inactivation treatment on the sample, it is possible to know the occurrence of abnormal data due to non-specific adsorption. .. That is, in the case of abnormal data due to non-specific adsorption, it is focused on that the measured value of the inactivated specimen increases.

As described above, the inactivation treatment is a treatment for inhibiting the antigen-antibody reaction of the target component in the specimen as the specimen pretreatment, and since such special pretreatment is required, There is a problem that the immunoassay becomes a very complicated operation.

The present invention solves the above problems and provides an immunoassay method and apparatus capable of measuring a value by a non-specific adsorption reaction by an ordinary analysis without performing pretreatment. The purpose is.

[0015]

To this end, the present invention is designed to inject a sample into a reaction detection container containing a solid phase carrier on which an antibody or an antigen is immobilized, and measure the components contained in the sample by an immunoreaction. In the immunoassay method, measurement is performed using a reaction detection container containing a solid phase carrier that does not immobilize an antibody or an antigen, and abnormal data is corrected based on the measured value. It is characterized by using the inner wall of the reaction detection container and fine granules.

The present invention also sets a reaction detection container containing a solid phase carrier on which an antibody or an antigen is immobilized on a reaction turntable having a plurality of positions, and an antigen of the sample or an antigen of the sample is subjected to an immune reaction with the antigen. Or an immunoassay device for quantitatively measuring the amount of antibody, which includes a reaction detection container, a sample cup, a storage turntable for storing a reagent bottle, a detector for detecting the amount of a labeled reagent in the reaction detection container, and a reaction turn. Quantification of the amount of antigen or antibody in the sample using a reaction detection container that has an arm mechanism that inserts and removes the reaction detection container from the table and dispenses the sample and reagent, and that contains a solid-phase carrier that does not immobilize the antibody or antigen It is characterized in that the measurement is performed to correct the abnormal data.

[0017]

In the immunoassay method and apparatus of the present invention, the inner wall of the reaction detection container and the fine granules are used as the solid phase carrier for the measurement, and the abnormal data is corrected based on the measured value. Abnormal data can be corrected by quantitatively measuring the amount of the antigen or antibody in the same sample without performing them and comparing them. Therefore, a complicated operation for correcting abnormal data can be eliminated.

[0018]

Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is a diagram for explaining one embodiment of the immunoassay method of the present invention, where A is a reagent cartridge, B is a blank reagent cartridge, 61 is a solid phase carrier, 62 is an antibody,
Reference numeral 63 represents the measured antigen, and 71 represents components other than the measured antigen.

The immunoassay method of the present invention comprises a reagent cartridge containing microparticles as a solid phase carrier containing a solid phase reagent having an antibody or an antigen immobilized on the surface of the solid phase carrier and having a discharge hole at the bottom (reaction detection). For a specimen that has been subjected to a normal analysis using container A and is positive, a blank reagent cartridge (correction) that contains only the solid phase carrier of the small-diameter granules that does not immobilize the antibody or antigen and that has a discharge hole at the bottom Reaction detection container) B for other analysis conditions under the same conditions as in the normal analysis. For normal analysis, see Figure 1.
As shown in (a), in the normal measurement, the reagent cartridge A
The value including the antigen 63 to be measured and the component 71 other than the antigen to be measured is measured by, but in the analysis using the blank reagent cartridge B as shown in FIG. The value is measured. Therefore, the non-specific adsorption reaction can be corrected by subtracting the latter measured value from the former measured value.

FIG. 2 shows an automatic immunoassay device 1 according to the present invention.
FIG. 3 is a layout diagram showing an embodiment, and FIG. 3 is a diagram showing an embodiment of a cartridge used in the automatic immunoassay device according to the present invention. In the figure, 1 is a reaction turntable, 2 is a cartridge turntable, 3 is a reagent turntable, 4 is a sample turntable, 5 is a sample cup, 6 is a disposable chip, 7-9 are arm mechanisms, 10 is a detector, 1
1 is dust, 12 is a control processing unit, 21 is a cartridge body, 22 is a filter, 23 is a solid-phase reagent, 24 is a discharge hole, 25 is an opening, 26 is an aluminum cap, 27 is an orient, and 28 is a tip. ..

In FIG. 2, a cartridge turntable 2 is a table for storing and rotating a disposable cartridge (reaction detection container) as shown in FIG. 3, and is composed of 10 removable cassettes. An example in which 30 cartridges can be stored is shown in FIG. According to this, since the same solid-phased antibody cartridge is stored in each section, a cartridge for 10 items can be prepared, and one of them is provided with a blank reagent cartridge for nonspecific adsorption reaction correction. The reagent turntable 3 is a table that stores and rotates reagent bottles of labeled antibodies and disposable chips for dispensing thereof, and shows an example in which reagent bottles for 10 types, that is, 10 items, can be stored. There is. The sample turntable 4 is a sample cup 5 containing a sample.
2 is a table for storing and rotating a disposable chip 6 for dispensing a sample, and shows an example in which two disposable chips 6 can be stored inside the table corresponding to each sample cup 5. The reaction turntable 1 is set with the cartridge of the cartridge turntable 2 1
As described above, the sample is dispensed, the labeled antibody is added, the stirring reaction by vibration, the washing, etc. are performed while rotating by position. The arm mechanisms 7 to 9 are mechanisms for inserting / removing a cartridge between the reaction turntable 1 and the cartridge turntable 2, the reagent turntable 3, and the sample turntable 4, and dispensing reagents and samples. The trajectories of circles a, b, and c
Is. The detector 10 is for injecting a luminescent reagent into the cartridge after the reaction to detect the amount of luminescence, and the dust 11 is about to discard the cartridge after the detection of the amount of luminescence.

As shown in FIG. 3, the cartridge used in the automatic immunoassay device according to the present invention has a cartridge main body 21 having a cylindrical shape, a solid phase reagent 23 contained therein, and a filter 22 provided below the solid phase reagent 23. Yes, and filter 2
A thin discharge hole 24 is provided under the portion 2 and the opening 25 at the upper end is closed by an aluminum cap 26.
The solid-phase reagent 23 is obtained by immobilizing an antibody on the surface of a granule having a diameter of about several tens of μm. Since the antibody and antigen of the solid-phase reagent 23 are proteins, they are easily decomposed.
It is immersed in a storage solution such as a buffer solution for maintaining

In addition, there is a cutout 27 in the portion where the discharge hole 24 is provided, and the tip 28 can be bent at the cutout 27 to be easily removed from the cartridge body 21. Can be penetrated. Since the discharge hole 24 is formed to have an extremely small diameter and the filter 22 is arranged, even when the tip portion 28 is removed from the cartridge body 21 when the cartridge is used, the dispensed sample or Reagents, washing water, etc. are not easily discharged from the discharge hole 24, but are discharged by supplying pressurized air from the opening 25 at the upper end or by sucking from the discharge hole 24.

Therefore, in the cartridge, the solid phase reagent 23 is stored on the filter 22 with the upper end completely sealed by the aluminum cap 26 and the lower end completely sealed by the tip portion 28, and stored in the cartridge turntable 2. Then, this cartridge is transferred from the cartridge turntable 2 to the reaction turntable 1 by the arm mechanism 7.
At the time of transfer to, the tip portion 28 of the dust 11 is removed, and the preservative solution is discharged and washed at the next position of the reaction turntable 1.

Next, the operation will be described based on the flow system of the automatic immunoassay device according to the present invention. FIG. 4 is an overall flow diagram of the automatic immunoassay device according to the present invention, in which 31 is a drain tank,
32 is a compressor, 33 is an in-out switching valve, 34 to 37, 51 and 53 are pumps, 38 to 41 are tanks, 42 is a three-way joint, 43 is a resistance tube, 44 is a preheater, and 45, 52 and 54 are valves. , 46 indicates a mixer.

As shown in FIG. 4, in the reaction turntable 1 having 29 positions, the flow system is based on the position (1) and is connected to a flow system for dispensing and washing samples and reagents. At the base point position (1), the cartridge is first set on the reaction turntable, and the reaction turntable is alternately rotated by two predetermined positions. After the reaction, the cartridge is the detector 10.
Moved to.

First, referring to FIG. 4, the reaction turntable 1
Each flow system connected to will be described.

The drain tank 31 is for accommodating the preservative liquid and the cleaning liquid discarded from each cartridge of the reaction turntable 1, and is connected to a drain passage provided in an annular shape below each position of the reaction turntable 1. To be done. The compressor 32 supplies pressurized air for discarding the preservative solution, cleaning immediately after that, cleaning by B / F separation, discarding the sample and reagent remaining at the tip of the disposable chip, and cleaning.

The tank 38 is for accommodating the luminescence auxiliary reagent, and the tanks 39 and 40 are for accommodating the luminescence reagents, respectively, and the in-out switching valve 33 and the pumps 34 to 37.
Is for sending a luminescence assisting reagent, a diluent, and a luminescence reagent. The buffer solution stored in the tank 41 is used as the diluting solution and the cleaning solution. As this buffer solution, a mixed solution of a surfactant, a sugar or the like which promotes an immune reaction is used. The tank 41 has a closed structure and is configured to supply pressurized air from the compressor 32 and apply pressure to feed the cleaning liquid, and the cleaning liquid passes through the resistance tube 43, the preheater 44, and the valve 45 and is stabilized. By controlling the temperature and flow rate to a predetermined level, the reaction is facilitated and the reaction is stabilized. Similarly, in the case of the luminescent reagent, a temperature may be stabilized during the luminescent reaction by adding a heater to the mixer 46. When injecting the luminescent reagent, the mixed material remains in the tube beyond the three-way joint 42.
Immediately before that, it is necessary to spit this out.

For example, in the pump suction step in which the in-out switching valve 33 is in the state shown in the drawing, the luminescence assisting reagent is sucked from the tank 38 by the pump 34, and the pump 35
Causes the diluent (water) to be sucked from the tank 41, and similarly, the pumps 36 and 37 simultaneously suck the luminescent reagent from the tanks 39 and 40. Then, when the in-out switching valve 33 is switched (the upper half is shifted to the right) and the pump discharge process is started, the luminescence assisting reagent and the diluent are heated to a predetermined temperature through the pre-heater 44, and the positions (29), It is injected into the cartridge of (4). Further, the luminescent reagent is mixed through the three-way joint 42 and the mixer 46 and injected into the cartridge of the detector 10.

In the cleaning process, the valve 45 is selectively opened and closed, and the buffer solution is injected from the tank 41 through the resistance tube 43, the preheater 44 and the valve 45 into the cartridges at the positions (3), (13) and (28). To be done. Then, next, the air valve is selectively opened and closed, and the compressed air is supplied from the compressor 32 to the cartridges at the positions (3), (13) and (28) through the air valve. For normal washing, wash solution (buffer solution)
Are injected and discarded with pressurized air four times.

At position (5), a sample dispensing system and a labeled antibody reagent dispensing system are connected so that the sandwich method and the competitive reaction method can be applied. These are respectively a sample cup or a reagent. It inhales and dispenses from a bottle using a special disposable chip. In this case, since the sample or reagent remains at the tip, a flow system of pressurized air is connected so as to blow them out by pressurized air. This is the flow system of the valve 52 in the sample dispensing system, the tip of the disposable chip is inserted into the sample cup of the sample turntable 4, the sample is sucked by the sampling pump 51, and the sample is dispensed into the cartridge at position (5). It is switched to this flow system after pouring. Similarly, when a reagent is dispensed, the tip of the disposable chip is inserted into the reagent bottle of the reagent turntable 3, sucked and dispensed by the reagent pump 53, and then the valve 54 is connected to the flow system of the pressurized air. Can be switched. Further, since the suction amount becomes unstable when the internal pressure rises, a valve for opening to the atmosphere is also provided.

Next, the rotation of the position of the reaction turntable 1 will be described.

At the position (1), the arm mechanism 7 operates to convey a new cartridge from the cartridge turntable 2 and remove the leading end of the cartridge to set it.

When the new cartridge is set in the position (1), even if the tip portion 28 shown in FIG. 3 is removed from the cartridge, the preservative solution in the cartridge is not discarded. Therefore, at the position (2), the upper opening of the cartridge is opened. Send pressurized air from to discard the storage solution in the cartridge.

At the next position (3), the cleaning valve is set at the upper opening of the cartridge, and the cleaning liquid and the pressurized air are alternately sent repeatedly, for example, four times to perform the cleaning.

Then, at position (4), the diluent is added. This is because, when blood, serum, urine, etc. are directly injected, various components may interfere with the immune reaction, so that the immune reaction is easily caused.

Then, at position (5), the sample is sucked from the sampling cup with the disposable tip and dispensed into the cartridge.

After that, the immune reaction (first reaction) is accelerated by vibrating and stirring each time it rotates by one position, and at the position (13), water supply and drainage by pressurized air are repeated four times for washing. By doing so, the B / F separation described above is performed.

The operation after the B / F separation will be described in detail. First, the position (13) is rotated in the forward direction by 20 positions and temporarily stopped at the position (4) to inject a diluent (buffer solution) as a buffer. , And further rotate 10 positions in the forward direction to advance to the position (14) one position before the previous time. Here, after stirring by vibration, it is similarly rotated in the forward direction of 20 positions and temporarily stopped at position (5) to dispense the labeled antibody. The diluting solution has a function of preheating to stabilize the reaction temperature, smoothing and promoting the immune reaction, and enhancing the stirring effect when the following labeling reagent is dispensed. This is the operation in the case of the sandwich method.

That is, by alternately performing the operation of rotating the pitch of 10 positions and the operation of rotating the pitch of 20 positions, the position is advanced one position from the previous position. Since this is done, the sandwich method can also employ an apparatus configuration in which the labeling reagent is dispensed at the sample dispensing position (5). As a result, the immunoassay can be performed by the same flow system in the competitive reaction method by controlling the rotation operation so that the sample and the labeled antigen are simultaneously dispensed at the position (5).

Then, similarly to the first reaction up to the position (27), the immune reaction (second reaction) is promoted by agitating while vibrating while alternately rotating by the pitch of 10 positions and the pitch of 20 positions, as in the first reaction. In step (28), B / F separation is performed again by washing.

Then, a luminescence assisting reagent for enhancing the luminescence is added at the position (29), and the cartridge is transferred to the detector 10 at the first position (1). Detector 10
Then, the amount of luminescence is measured immediately after adding the luminescent reagent to the cartridge. The luminescent reagent depends on the labeling substance,
For example, in the case of Acridinium, a mixed solution of hydrogen peroxide and an alkali is used, and in the case of Luminol, a mixed solution of hydrogen peroxide and Fe ions is used, but these react in a short time. The respective bottles are simultaneously injected through the three-way joint 42 and the mixer 46.

In the above-mentioned operation, for example, after standing still at position (1) for 12 seconds, it rotates in the forward direction at a pitch of 20 positions, stands still at position (21) for 12 seconds, and then moves to position (2) for 10 positions. Rotate at a pitch of, and advance one position at a time from position (1) to position (2) over 24 seconds. At position (1), the cartridge is first transferred to the detector 10 within 12 seconds, and The cartridge is brought from the cartridge turntable 2 and set. In this case, it takes about 3 minutes for the first reaction and about 5 for the second reaction.
It takes a minute, and an immune reaction measurement of one sample can be performed in about 10 minutes as a whole, and a measurement speed of about 150 tests / hr can be realized.

When measuring a plurality of items with one sample, at the position (1), the cartridges of the solid-phase reagents corresponding to the respective measurement items are set on the cartridge turntable, and the same sample is put on those cartridges. Is dispensed, and a reagent corresponding to the measurement item is further dispensed. Then, the amount of light emission is measured by the detector 10, and the process ends. If measurement is required again, use the remaining disposable tip to dispense the sample. Therefore, in the sample turntable of FIG. 2, two disposable chips are stored for each sample. The re-measurement is not limited to the case where the measured value shows an abnormal value that significantly deviates from the preset range, and the determination value is given in advance for each measurement item as the primary screening, and the next measurement item is determined from the determination result. There are cases where it is set. For example, in the examination of serum hepatitis, the HBS antigen is first examined, and if the result is positive, the HBE or HBS antigen is examined. Further, the reason why the disposable disposable chip is used is that the measuring range is very wide in the case of immunoassay, and the conventional pipette cannot completely wash it.

The present invention is not limited to the above embodiment, but various modifications can be made. For example, as a result of performing a normal analysis, retesting may be automatically performed on a sample determined to be positive, or based on the previous value comparison and patient information in the retesting determination logic, a specific sample of positive samples may be determined. The retesting of the sample may not be performed. In other words, data for half a year may be stored, and a function of not performing retesting may be incorporated for a sample of the same person determined to be abnormal last time. If the analytical cartridge and the solid phase carrier are different in the same device,
Install multiple types of blank reagent cartridges. Further, although the fine granules are used as the solid phase carrier, large spheres may be used or the inner wall of the reaction detection container may be used. When the liquid is drained from the cartridge, the liquid may be drained not only from the bottom but also from the upper opening. In this case, the solid phase carrier composed of fine granules or large spheres may be made to stick to the inner wall of the cartridge with a magnet by using a magnetic material.

[0047]

As described above, according to the present invention, an analysis is performed using a reagent cartridge and a blank reagent cartridge without a reagent. Therefore, it is sufficient to perform exactly the same analysis by changing the cartridge. It is possible to eliminate complicated operations such as the pretreatment of. Therefore,
As a result of the analysis, even if a complicated operation is not performed, it is displayed as abnormal, but in reality, it is possible to suppress the appearance of false positives that are likely to be normal, and it is possible to improve the reliability of the data. Moreover, since the analysis cartridge and the solid-phase carrier do not usually change depending on the item, the blank reagent cartridge can be the same for a plurality of analysis items. That is, it suffices to prepare as many cartridges as the number of types of beads used. Further, the re-inspection can be performed easily by rotating the sample turntable and aspirating the sample requiring re-inspection again for analysis.

[Brief description of drawings]

FIG. 1 is a diagram for explaining one example of the immunoassay method of the present invention.

FIG. 2 is a layout diagram showing one embodiment of the automatic immunoassay device according to the present invention.

FIG. 3 is a diagram showing an embodiment of a cartridge used in the automatic immunoassay device according to the present invention.

FIG. 4 is an overall flow diagram of the automatic immunoassay device according to the present invention.

FIG. 5 is a diagram for explaining the measurement principle by the sandwich method and the competitive method.

FIG. 6 is a diagram for explaining a process for generating and correcting abnormal data due to non-specific adsorption.

[Explanation of symbols]

A ... Reagent cartridge, B ... Blank reagent cartridge, 1 ... Reaction turntable, 2 ... Cartridge turntable, 3 ... Reagent turntable, 4 ... Sample turntable, 5 ... Sample cup, 6 ... Disposable chip, 7-9 ... Arm Mechanism, 10 ... Detector, 11 ... Dust, 12 ... Control processing unit, 21 ... Cartridge body, 22
... filter, 23 ... solid-phase reagent, 24 ... discharge hole, 25 ...
Opening, 26 ... Aluminum cap, 27 ... Orimé, 28 ...
Tip part, 61 ... Solid phase carrier, 62 ... Antibody, 63 ... Measured antigen, 71 ... Components other than measured antigen

Claims (4)

[Claims] 1. In an immunoassay method in which a sample is injected into a reaction detection container containing a solid-phase carrier on which an antibody or an antigen is immobilized, and a component contained in the sample is measured by an immunoreaction, the antibody or the antigen is immobilized. An immunoassay method characterized by performing measurement using a reaction detection container containing a solid phase carrier that does not change, and correcting abnormal data based on the measured value. 2. The immunoassay method according to claim 1, wherein the inner wall of the reaction detection container is used as the solid phase carrier. 3. The immunoassay method according to claim 1, wherein microparticles are used as the solid phase carrier. 4. The amount of the antigen or antibody of the sample by the reaction reaction table containing the solid phase carrier on which the antibody or antigen is immobilized is set on the reaction turntable having a plurality of positions and the immune reaction with the antigen or antibody of the sample is performed. An immunoassay device for performing quantitative measurement of a reaction detection container, a sample cup, a storage turntable for storing a reagent bottle, a detector for detecting the amount of a labeled reagent in the reaction detection container,
And a reaction detection container equipped with a solid-phase carrier that does not immobilize the antibody or antigen and is equipped with an arm mechanism that inserts and removes the reaction detection container from the reaction turntable and dispenses the sample and reagent. An immunoassay device characterized by being configured to perform quantitative measurement of an amount and correct abnormal data.