JPS6047963A - Immunological analytical apparatus - Google Patents

Abstract

PURPOSE:To make it possible to automatically analyze the amount of an antigen or antibody with high accuracy, by providing a first count means which counts a number of microcapsules in a reagent and outputs the count value Na and a second count means which counts a number of residual microcapsules in a solution after antigen-antibody reaction and otputs the count value Nb. CONSTITUTION:A first count means 10 is constituted so as to count a number (Na) of microcapsules in a predetermined amount of a reagent supplied from a reagent supply means to output data showing the number Na to an operation means, and to emit a predetermined amont of a reagent into the reaction container in a reaction means and, for example, can be constituted by utilizing a corpuscle sorting apparatus utilizing pattern recognition and a corpuscle counter for detecting light scattering and the change in conductivity. A second count means 16 is constituted by utilizing, for example, the corpuscle sorting apparatus utilizing pattern recognition and the corpuscle counter for detecting light scattering and the change in conductivity so that a number Nb of residual microcapsules in a predetermined amount of a solution sent from a solution supply means 15 are counted to output data showing the number Nb to the operation means.

Description

DETAILED DESCRIPTION OF THE INVENTION [Technical Field of the Invention] The present invention relates to an immunoassay device that automatically analyzes the amount of antigen or antibody in a sample using an antigen-antibody reaction.

[Technical background of the invention and its problems]

Conventionally, there have been many methods for measuring the amount of antigen or antibody using antigen-antibody reactions [[Introduction to Clinical Immunology J P1
23-P132. Gakuin-in].

However, since the radioimmunoassay method deals with radioactive substances, the analytical equipment is large and expensive, and the disposal of radioactive waste is a problem. Although immunofluorescence allows visual observation through a fluorescence microscope, it is not quantitative (and the analytical operations are complicated).

Methods using precipitation reactions, antigen-binding ability, clotting reactions, and neutralization tests are manual methods, so the operations are complicated, require long analysis operations, and the analytical values may vary depending on factors such as temperature and reaction time. Easy to cause errors. In any of the above methods, the ability to analyze a large number of samples in succession is the number of times.

[Purpose of the invention]

This invention was made in view of the above-mentioned circumstances, and allows for continuous analysis processing of a large number of samples, easy handling,
The object of the present invention is to provide an immunoassay device that can automatically analyze the amount of antigen or antibody with high precision without causing individual errors by operators or errors due to temperature or reaction time.

[Summary of the invention]

The outline of the present invention for achieving the above object includes a first counting means for counting the number of microcapsules in a reagent having microcapsules that bind antigens or antibodies to the surface thereof, and outputting the counted value Na; , a sample having an antibody or an antigen in the reagent subjected to the first counting means, a reaction means for destroying the microcapsules by an antigen-antibody reaction, and a number of microcapsules remaining in the liquid after the antigen-antibody reaction. a second counting means for counting and outputting the counted value Nb; said first counting means and said second counting means;
It is characterized by being equipped with calculation means for calculating (Nb-Na)/Nb by inputting the count values Na and Nb output from the counting means, and calculating the concentration of the antibody or antigen in the sample from the calculation result. That is.

[Embodiments of the invention]

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

An immunoassay device that is an embodiment of the present invention includes a sample supply means, a reagent supply means, a first counting means for counting the number of microcapsules in the reagent and outputting the counted value, and a 4+J microcapsule count. A reaction means for mixing a reagent and a sample in which the number of capsules has been counted and performing an antigen-antibody reaction for a predetermined time and at a predetermined reaction temperature, and a second counting means for taking out the solution after the antigen-antibody reaction from the reaction means and described later. a second counting means for counting the number of microcapsules remaining in the liquid after mJ antigen-antibody reaction and outputting the counted value; calculation means for calculating the amount of antigen or antibody based on the count data output from the counting means of No. 2; output display means for outputting and displaying the results of the calculation means; and control means for controlling the operation of each of the means. It is composed of:

As shown in the drawings, the sample supply means includes a conveyance means, for example, an endless belt 2, which rotates intermittently in a horizontal plane by a driving 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 6 are attached at predetermined intervals to a plurality of sample containers 6, which are arranged at a predetermined position with respect to the endless belt 2, and a predetermined amount of the sample in the sample containers 6 is aspirated with a pipetter 4,
It is composed of

As shown in the drawing, the reagent supply means includes a reagent cassette 7 having a large number of reagent containers 6 containing reagents, a pipettor 8 in which a predetermined amount of reagent is aspirated in the reagent container 6, and then a predetermined amount of the reagent is aspirated. A suction/discharge device 9 for supplying a reagent to a first counting means, which will be described later, is configured with a metering pump, for example.

Here, the reagent is a saline solution with microcapsules, such as sheep red blood cells, binding antigens or antibodies to the surface. Whether antigen or antibody is bound to the surface of the microcapsule is determined by whether the amount of antigen or antibody in the sample is to be measured. For example, when measuring the amount of antigen in the sample, binding to the surface of the microcapsule is determined by binds the antibody. Coupling of antibodies to microcapsules, such as sheep red blood cells, can be easily accomplished by known methods.

As shown in the drawing, the first counting means 10 counts the number aNa of microcapsules in a predetermined amount of reagent supplied from the reagent supplying means, and generates data indicating the number Na, which will be described later. After that, the predetermined amount of the reagent is discharged into a reaction container in a reaction means to be described later. It can be configured using color/li.

As shown in the drawings, the reaction means includes a conveying means, for example, an endless belt 12, which rotates intermittently in a horizontal plane by a drive pulley 11 driven by a drive device (not shown) and a driven pulley (not shown); A plurality of reaction vessels 13 installed at predetermined intervals, and a constant temperature bath 14 containing constant temperature water at a predetermined temperature for immersing the reaction vessels 13.
It is composed of: Since the constant temperature bath 14 has a predetermined length along the direction of movement of the reaction container 16,
By advancing the reaction vessel 1 while being immersed in constant temperature water in the thermostatic bath 14, the sample and reagent can undergo an antigen-antibody reaction at a predetermined temperature and for a predetermined time within the reaction vessel 1.

As shown in the drawings, the liquid supply means is configured to aspirate the liquid in the reaction container 13 after the antigen-antibody reaction is completed using a pipe sink (not shown) and send it to a second counting means 16, which will be described later. For example, the suction/discharge device 15 may include a metering pump.

The second counting means 16 is as shown in the drawing.

For example, a blood cell classification device using pattern recognition is configured to count the number Nb of microcapsules remaining in a predetermined amount of liquid delivered from the liquid supply means 15 and output data indicating the number Nb to a calculation means to be described later. It is constructed using a blood cell counter that detects changes in light scattering and conductivity.

As shown in the drawing, the calculation means 17 inputs the output data from the first counting means 10 and the output data from the second counting means 16, and executes the calculation of (Nb-Na)/Nb. The system is configured to determine the antigen amount or antibody value from the calculation result based on a correspondence table between (Nb-Na)/Nb and the antigen amount or antibody amount, which is stored in advance through simulation or the like, and to output this. be done.

Although not shown in the figure, the output display means displays the amount of antibody or antigen, which is the output data from the calculation means 17, on a monitor or prints it out on a data sheet.

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

Samples α collected from a large number of subjects, such as patients, are stored in each of a plurality of sample containers in the sample supply means.
, β, γ, etc. are accommodated separately.

Further, reagents R, 2, .
Contain... Now, in the drawing, when trying to test six items for the sample α in the sample container 6, the suction/discharge device 5 moves the sample α in the sample container 3 into a plurality of reaction containers 6 that are intermittently moved. Of these, predetermined amounts are dispensed into three reaction vessels A, B, and C. On the other hand, the reagent supply means 11 times sucks a predetermined amount of six reagents R1, R2, and 3 from the six reagent containers 6, and supplies them to the first counting means 10. The first counting means 10 is a reagent R,
The numbers Na1, Na2, and Na3 of microcapsules contained in each of R2 and R2 are counted, and the data is output to the calculation means 17. In the drawing, reaction vessel A is
When moving to position a in the thermostatic chamber 14, the first counting means 10 supplies the reagent fiR1 to the reaction vessel A, and similarly, the reagent R2 is supplied to the reaction vessel B, and the reagent R3 is supplied to the reaction vessel C.
is supplied, and the sample and reagent are mixed within the reaction vessel. @In the mud tank 14, reaction vessels yJB and C move from position a to g.
While moving intermittently to the position, the
The antibody in the sample and the antigen bound to the surface of the microcapsule in the reagent R, 2, and 2 undergo an antigen-antibody reaction,
Microcapsules, such as sheep red blood cells, are hemolyzed by an antigen-antibody reaction depending on the amount of antibody. Reaction vessels A, B, CIJ
When the liquid in the reaction vessels A, B, and C reaches the position ``-g, the pivot of the liquid supply means 15 transfers the liquid in the reaction vessels A, B, and C to the microcapsules in the liquid in the reaction vessels A, B, and C, which are sequentially delivered. The remaining numbers N01, Nb2, and Nb3 are counted and the data is output to the calculation means 17.The calculation means 17 is the first counting means 1
0 and the data output from the second counting means 16, (Nb1-Na,) /Nb,, (Nb2 Na
2) Calculate /Nb2, (Nb3Na3)/Nb3, determine the amount of antibody, output this, and display or print out the amount of antibody using the output display means.

Although one embodiment of this invention has been described in detail above, this invention is not limited to the above embodiment (and can be implemented with appropriate modifications within the scope of not changing the gist of this invention). Needless to say.

In the embodiment, three suction and discharge devices 5.9.1
5 is used, but in order to avoid mixing of the sample, reagent, and post-reaction liquid, it may be replaced with a single suction and discharge device that can suction and discharge each of the liquids by switching the pulp.

Further, in the embodiment, two counting means 10.1
5 is used, but it may be replaced with a single counting means capable of counting the number of microcapsules in the reagent and the solution after reaction by changing the pulp.

〔Effect of the invention〕

According to the invention described in detail above, a large number of samples can be continuously analyzed and multi-item analysis can be performed. In addition, since the analysis process is automated and the reaction conditions are controlled at a constant level, there are no errors due to individual errors by operators or variations in reaction conditions, and it is possible to determine the amount of antigen or antibody in a sample with high accuracy. can. In this invention, since the amount of antigen or antibody is determined by counting the number of microcapsules, the counting can be done accurately and there is no problem of waste disposal.

[Brief explanation of the drawing]

The drawings are explanatory diagrams showing one embodiment of the present invention. 10... first counting means, 16 - second counting means,
17... Calculation means.

Claims (1)

[Claims] a first counting means for counting the number of microcapsules in a reagent having microcapsules that bind to the surface of an antigen or antibody and outputting the counted value Na; Alternatively, in addition to the sample having an antigen, a reaction means for destroying the microcapsules in Step 11 by an antigen-antibody reaction, and counting the number of microcapsules remaining in the liquid after the antigen-antibody reaction, and the counted value Nb
a second counting means that outputs the count values Na, Nb output from the first counting means and the second counting means;
1. An immunoassay device comprising: calculation means for inputting (Nb-Na)/Nb and determining the concentration of an antibody or antigen in a sample from the calculation result.