JPH0672887B2 - Immunoanalyzer - Google Patents

Description

TECHNICAL FIELD OF THE INVENTION The present invention relates to an immunoassay device for automatically analyzing the amount of antigen or the amount of antibody in a sample using an antigen-antibody reaction.

[Technical background of the invention and its problems]

Conventionally, there are many methods for measuring the amount of antigen or the amount of antibody using the antigen-antibody reaction ["Introduction to Clinical Immunology" P123-
P132, Medical School].

However, the method using Radio Time
Since radioactive substances are handled, the analyzer becomes large in size, and therefore the analyzer becomes expensive, and the disposal of radioactive waste becomes a problem. Although the immunofluorescence method is visible through a fluorescence microscope, it is not quantitative and the analysis operation is complicated. Precipitation reaction, antigen binding ability, agglutination reaction,
Since the method using the neutralization test is a manual method, the operation is complicated, a long analysis operation time is required, and further, an error is likely to occur in the analysis value due to factors such as temperature and reaction time. In any of the above methods, it is difficult to continuously analyze a large number of samples.

[Object of the Invention]

The present invention has been made in view of the above circumstances, and continuously analyzes a large number of samples for easy handling,
It is an object of the present invention to provide an immunoassay device capable of highly accurate automatic analysis of an antigen amount or an antibody amount without causing an individual error due to an operator, an error due to a temperature or a reaction time.

[Outline of Invention]

The outline of the present invention for achieving the above object is to provide a reagent supply means for supplying a reagent having a microcapsule for binding an antigen or an antibody to the surface, and the number of the macrocapsules in the reagent supplied from the reagent supply means. First counting means for counting and outputting the count value Na, sample supply means for supplying a sample, reagent supplied from the reagent supply means to the first counting means, and sample from the sample supply means A reaction container for mixing and, a second counting means for counting the number of remaining microcapsules in the mixed liquid reacted by the mixing and outputting the count value Nb, the first counting means and the And a calculation means for calculating the (Na-Nb) / Na by inputting the count values Na and Nb output from the second counting means to obtain the antigen amount or the antibody amount in the sample. It is intended.

Example of Invention

An embodiment of the present invention will be described with reference to the drawings.

An immunoassay device according to an embodiment of the present invention includes a sample supply unit, a reagent supply unit, a first counting unit that counts the number of microcapsules in a reagent, and outputs the count value, and the microcapsule. The reaction means for performing the antigen-antibody reaction for a predetermined time and at the predetermined reaction temperature by mixing the reagent whose number has been counted with the sample, and the liquid after the antigen-antibody reaction are taken out from the reaction means and used as the second counting means described later. Liquid supply means for supplying, second counting means for counting the number of remaining microcapsules in the liquid after the antigen-antibody reaction, and outputting the count value, the first counting means and the second counting Calculating means for calculating the amount of antigen or the amount of antibody based on the count data output from the means, output display means for outputting and displaying the result of the calculating means, and control means for controlling the operation of each means It has composed.

As shown in the drawings, the sample supply means is a conveying means such as an endless belt 2 that intermittently moves around a horizontal plane by a drive pulley 1 driven by a drive device (not shown) and a driven pulley (not shown), and the endless belt 2 A plurality of sample containers 3 attached at predetermined intervals to the endless belt 2 and arranged at predetermined positions with respect to the endless belt 2, and the sample in the sample container 3 is sucked by a predetermined amount with a pipettor 4,
Next, a discharge device 5 for discharging the predetermined amount of the sample into a reaction container in a reaction means described later, for example, a metering pump is provided.

As shown in the drawing, the reagent supplying means sucks a predetermined amount of a reagent cassette 7 having a large number of reagent containers 6 for storing the reagents, a reagent in the reagent container 6 with a pipettor 8, and then a predetermined amount of the reagent. It is configured to have a suction / discharge device 9 for supplying a reagent to a first counting means described later, for example, a metering pump. Here, the reagent is a microcapsule that binds an antigen or an antibody to the surface, for example, a physiological saline solution containing sheep red blood cells. Whether to bind the antigen or antibody to the surface of the microcapsule is determined by whether to measure the amount of antigen or the amount of antibody in the sample. For example, when measuring the amount of antigen in the sample, Binds the antibody. Binding of antibodies to microcapsules such as sheep erythrocytes can be easily performed by known methods.

As shown in the drawing, the first counting unit 10 counts the number Na of microcapsules in a predetermined amount of reagent supplied from the reagent supply unit and outputs data indicating the number Na to an arithmetic unit described later. It is configured to output and then discharge the predetermined amount of the reagent into a reaction container in a reaction means described later. For example, a blood cell sorting device utilizing pattern recognition, a blood cell counter for detecting light scattering, and a change in conductivity. Can be configured using.

As shown in the drawings, the reaction means includes a conveying means such as an endless belt 12 and an endless belt 12 which are rotated by a driving pulley 11 driven by a driving device (not shown) and a driven pulley (not shown) to intermittently move in a horizontal plane. It comprises a plurality of reaction vessels 13 mounted at a predetermined interval, and a constant temperature bath 14 for containing constant temperature water in which the reaction vessels 13 are immersed, at a predetermined temperature. Since the constant temperature bath 14 has a predetermined length along the traveling direction of the reaction vessel 13, by advancing the reaction vessel 13 while being immersed in the constant temperature water in the constant temperature bath 14,
The sample and the reagent can react with each other in the reaction container 13 at a predetermined temperature and for a predetermined time.

As shown in the drawing, the liquid supply means is configured to suck the liquid in the reaction container 13 that has completed the antigen-antibody reaction with a pipette (not shown) and send it to the second counting means 16 described later. For example, the suction / discharge device 15 is configured to have, for example, a metering pump.

As shown in the drawing, the second counting unit 16 counts the remaining number Nb of microcapsules in a predetermined amount of liquid delivered from the liquid supply unit 15 and calculates the data indicating the number Nb, which will be described later. For example, a blood cell classification device using pattern recognition, a blood cell counter for detecting light scattering, and a change in conductivity is used for outputting to the means.

As shown in the drawing, the calculating means 17 is a first counting means.
The output data from 10 and the output data from the second counting means 16 are input, the calculation of (Na-Nb) / Na is executed, and (Na-Nb) / Na which is obtained and stored in advance by simulation or the like is stored. The amount of antigen or the amount of antibody is determined from the calculation result based on the correspondence table between the amount of antigen and the amount of antibody or the amount of antibody, and this is output.

Although not shown in the figure, the output display means is a calculation means 17
The amount of antibody or the amount of antigen, which is the output data, is displayed on a monitor or printed out on a data sheet.

Next, the operation of the above configuration will be described.

A plurality of samples α, β, γ, ... Further, reagents R ₁ , R _2, ... According to the inspection item are stored in a plurality of reagent containers 6 in the reagent cassette 7 in the reagent supply means. Now, in the drawing, when an inspection of three items is performed for the sample α in the sample container 3, the sample α in the sample container 3 is three out of the plurality of reaction containers 3 which are intermittently moved by the suction / discharge device 5. A predetermined amount is dispensed into each of the reaction containers A, B, and C. On the other hand, the reagent supply means sequentially sucks a predetermined amount of three kinds of reagents R ₁ , R ₂ and R ₃ from the three reagent containers 6 and supplies them to the first counting means 10. The first counting means 10 counts the number of microcapsules Na ₁ , Na ₂ and Na ₃ contained in each of the reagents R ₁ , R ₂ and R ₃ and outputs the data to the computing means 17. In the drawing, the reaction container A is a thermostatic chamber.
The reagent R ₁ is supplied to the reaction container A from the first counting means 10 when it is moved to the position a in 14 and the reaction container B is similarly supplied.
Is supplied with the reagent R ₂ and the reaction container C is supplied with the reagent R ₃ , and the sample and the reagent are mixed in the reaction container. While the reaction vessels A, B, and C intermittently move from the position a to the position g in the constant temperature bath 14, the antibody and the reagent in the sample are kept at a predetermined temperature for a predetermined time.
The antigens bound to the surface of the microcapsules in R ₁ , R ₂ and R ₃ react with the antigen-antibody reaction, and the antigen-antibody reaction according to the amount of the antibody causes hemolysis of the microcapsules such as sheep red blood cells.
When the reaction vessels A, B, and C reach the position of g, the reaction vessels A,
The liquids in B and C are sequentially sucked by a pipettor (not shown) of the liquid supply means 15 and sequentially sent to the second counting means 16. The second counting means 16 determines the number of remaining microcapsules in the liquid in the reaction vessels A, B and C, which are sequentially delivered.
Nb ₁ , Nb ₂ , and Nb ₃ are counted, and the data is output to the calculation means 17. The calculation means 17 inputs the data output from the first counting means 10 and the second counting means 16 (Na ₁ -N
b ₁ ) / Na ₁ (Na ₂ -Nb ₂ ) / Na ₂ and (Na ₃ -Nb ₃ ) / Na ₃ are calculated to obtain the antibody amount, which is output, and the output display means displays the antibody amount. Or printed out.

Although one embodiment of the present invention has been described in detail above, the present invention is not limited to the above embodiment, and can be appropriately modified and carried out within a range not changing the gist of the present invention. Needless to say.

In the above embodiment, three suction / discharge devices 5, 9, 15 are used.
However, a single suction / discharge device capable of suction / discharge of each of the liquids by switching the valves may be substituted so as not to mix the sample, the reagent and the liquid after the reaction.

Further, in the above-mentioned embodiment, the counting means 10 and 15 for two phases are used. However, by switching the valves, a single counting means capable of counting the number of microcapsules in the reagent and the liquid after the reaction can be used instead. May be.

〔The invention's effect〕

According to the present invention described in detail above, a large number of samples can be continuously analyzed and analyzed in multiple items. In addition, since the analysis process is automated and the reaction conditions are controlled to be constant, there is no error due to individual error by the operator or variation in reaction conditions, and the amount of antigen or antibody in the sample can be obtained with high accuracy. . In this invention, since the amount of antigen or the amount of antibody is obtained by counting the number of microcapsules, the counting can be performed accurately and the problem of waste disposal does not occur.

[Brief description of drawings]

The drawings are explanatory views showing an embodiment of the present invention. 10 ... First counting means, 16 ... Second counting means, 17 ...
Computing means.

Claims (1)

[Claims] 1. A reagent supply means for supplying a reagent having a microcapsule for binding an antigen or an antibody to a surface, and the number of the macrocapsules in the reagent supplied from the reagent supply means is counted, and the counted value Na , A sample supply means for supplying a sample, and a reaction container for mixing the reagent supplied from the reagent supply means to the first counting means with the sample from the sample supply means. And a second counting means for counting the number of remaining microcapsules in the mixed liquid reacted by the mixing and outputting the count value Nb, and output by the first counting means and the second counting means. And an arithmetic means for calculating (Na-Nb) / Na by inputting the count values Na and Nb to obtain the antigen amount or the antibody amount in the sample.