JP2002286719A - Method for analyzing and evaluating agglutination reaction using a plurality of parameters and vessel used for the method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an analyzing and evaluating method capable of excluding individual difference from among patients or an error in the sampling operation and performing a high reliability judgement of agglutination reaction accurately. SOLUTION: The method to analyze and evaluate the agglutination reaction is to be performed in a judging vessel having a plurality of judging parts at the bottom of one reaction part, wherein the judging parts have different parameters, and is embodied through such processes as, (a) a subject and reagent are added to the vessel and subjected to an immunological agglutination reaction, (b) the vessel is left stationarily, and (c) the agglutination patterns in all judging parts are observed and subjected to a comparison.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a method and an apparatus for analyzing and evaluating a biological agglutination reaction.

[0002]

2. Description of the Related Art Biological analysis is performed through a biological reaction that specifically reacts with various test substances on a specimen. For example, in immunological blood analysis, a method for measuring immune-related substances such as antigens and antibodies contained in a sample is generally used for performing ABO and Rh blood group tests and irregular antibody tests. An immunoassay is used. An example of such a method is described, for example, in "Transfusion at a glance" (Takayoshi Asai, et al., Medical Science International, 1998). For example, using a reaction container such as a glass plate or a test tube, a patient's 5% erythrocyte suspension or standard blood cells (2 to 5
%) A suspension and a specific antiserum or patient serum are quantitatively dispensed, mixed, centrifuged if necessary, and resuspended to determine the presence or absence of aggregation. However, such a method may not be able to be used for an ABO blood type back test, a Rh blood type test, an irregular antibody, or the like having a weak cohesive bond. That is, once aggregated, aggregation may be broken by resuspension, and aggregation may not be confirmed.

Conventionally, a measuring method using a “particle agglutination determination container” has been developed to solve such a problem. For example, Japanese Patent Publication No. 61-44268 discloses a container for judging particle agglomeration having a plurality of steps for forming a stable base layer of settled particles on an inclined surface.
It performs BO and Rh blood typing, irregular antibody testing, and other immunological agglutination reactions. That is, using a particle agglutination determination container having a plurality of steps, the container contains the blood particles of the blood whose blood type is to be determined and the standard antiserum reagent and stirs, and the test solution containing the particles is allowed to stand still. In this state, the aggregation pattern formed on the bottom surface by natural settling is clearly determined. This is a method for confirming aggregation of particles such as blood particles. Therefore, the document proposes that it is important to contain the particles contained in the container in an appropriate number (ie, at an appropriate concentration) in order to make a correct determination.

[0004] In addition, depending on the disease, even when ordinary operations are performed, the particle concentration of blood particles or the like finally prepared varies, or when natural antibodies are reduced, the particle concentration is appropriately adjusted to a desired concentration. May not be accommodated in the container.
In such a case, it is difficult to make a correct determination. In some cases, a blood test in the clinic only gives an aggregation pattern that is so weak that a positive or negative judgment cannot be made. However, there is no method in the prior art that can cope with such a case and identify the cause.

[0005]

SUMMARY OF THE INVENTION In view of the above situation, an object of the present invention is to eliminate a difference between patients and an error in a sampling operation, and to perform a highly reliable and accurate method for judging an agglutination reaction. It is to provide.

[0006] Even when the cohesive bond is weak,
An object of the present invention is to provide a determination method capable of determining its presence with high accuracy.

[0007]

Means for Solving the Problems As a result of earnest research for solving the above problems, the present inventors have found the following means. That is, a method for analyzing and evaluating an agglutination reaction in a determination vessel having a plurality of determination sections at the bottom of one reaction section, wherein the plurality of determination sections have different parameters from each other, and the following steps; And (c) observing the agglutination pattern in all of the determination sections, and (c) observing the aggregation pattern in all of the determination sections. A method for analyzing and evaluating an agglutination reaction, comprising analyzing and evaluating the agglutination reaction by comparing these agglutination patterns.

[0008]

[0009]

A preferred embodiment of the present invention is a method for analyzing and evaluating an agglutination reaction in a judgment vessel having a plurality of judgment sections at the bottom of one reaction section, wherein the plurality of judgment sections mutually (A) performing an immunological agglutination reaction in the determination container; (b) allowing the determination container to stand still; and (c) in all determination units. This is a method for analyzing and evaluating an agglutination reaction, which comprises observing an agglutination pattern and analyzing and evaluating the agglutination reaction by comparing the agglutination patterns.

That is, a plurality of data are obtained for one sample at the same time by making a determination using a plurality of determination sections provided with different parameters, and the data are compared.
This method can analyze and evaluate the agglutination reaction with high reliability.

More specifically, the method of the present invention comprises the steps of: adding one set of a sample and a reagent to a determination system having a plurality of independent determination units having different parameters in one reaction system; The agglutination reaction is performed, the agglutination reaction is allowed to stand, and the agglutination pattern is observed and compared with each other to evaluate the presence or absence of the agglutination reaction and / or the intensity of the agglutination reaction. At 1
This is a method of evaluating the authenticity of the result by comparing data obtained for a sample.

By making a decision on one sample under a plurality of parameters, a more accurate decision can be provided,
It is possible to obtain a decision indicating reconditioning and / or retesting. As a result, more accurate judgment can be performed, and high reliability of the analysis and evaluation is achieved.

The term "immunological agglutination" as used herein includes all general immunological agglutination and immunological agglutination-like reactions. For example, hospitality inspection, back inspection, Rh
Blood type tests such as the expression and Du test include methods generally referred to as a test tube method and a terraced method. In an irregular antibody test and a blood cell antigen test such as an HLA antigen and a human platelet-specific antigen, for example, , Mixed passive agglutination test and the like.

As used herein, the term "specimen" refers to a subject to be analyzed by the present method, which is a sample containing blood, serum, blood cells, etc., a natural antibody of type A or B, irregular erythrocytes, etc. It is a sample that contains or may contain antibodies, cell antigens such as platelets, lymphocytes, monocytes, and granulocytes, or antibodies thereof. These antigens or antibodies may be derived, for example, from animal antigens or antibodies such as humans, dogs, cats, horses, cows and sheep, and from pathogens such as viruses and bacteria.

The term "parameter" as used herein is:
The figure shows the volume of the judging unit region provided in the judging unit, the form of the bottom of the judging unit region, particularly the inclination angle of the slope forming at least a part of the bottom, the presence or absence of terraced, the type of terraced, and the like. In the method of the present invention, the above parameters are used alone and the parameters provided for each determination unit included in one reaction system are changed so that comparison can be performed between data obtained for each determination unit. Alternatively, any one of the above parameters is used in combination, and the parameters provided for each determination unit included in one reaction system are made different.

As used herein, the term "inclination angle of the inclined surface" refers to the inclination angle of the inclined surface that forms at least a portion of the bottom of the determination unit, and the angle is a plane that forms the bottom of the determination container. And the inner angle of the angle formed by the plane parallel to.

The test tube method is a method for judging the presence or absence of an immunological agglutination reaction by observing the presence or absence of agglutination generated therein using a test tube. The test tube method can be used in various blood group tests such as front and back tests and Rh-type tests. The procedure is described, for example, in "Transfusion at a glance" (Takayoshi Asai, et al., Medical Science International, 199).
8 years).

For example, in the case of a front test, anti-A serum or anti-B serum is added to a test tube, and then patient blood cells are added. This is gently shaken to observe and determine the presence or absence of aggregation. In the case of Rh blood test, anti-D serum is added to a test tube, and the patient's blood cells are added thereto. Mix and centrifuge.
Thereafter, the sample is resuspended and observed for the presence or absence of aggregation to make a judgment.
In the case of the back test, standard blood cells are added to a test tube, the serum of a patient is added, mixed well, centrifuged, resuspended, and the presence or absence of aggregation is observed and determined. The method of the present invention can be applied to such a method.

The terraced method is described in, for example, Japanese Patent Publication No. 5-65.
823, a method for performing an immunological agglutination reaction using a glass plate or a plastic plate having a depression with a terraced inner wall.

The mixed passive agglutination method is an indirect agglutination reaction caused by an antigen passively adsorbed and bound to blood cells or the like. For example, when the type of platelets is determined, a known antibody is reacted with platelets of a patient with immobilization, and a determination is made by agglutination using anti-human IgG-bound sheep erythrocytes. The present invention can be applied to such a method.

The present invention further provides a container for judging agglutination reaction. A preferred embodiment of the present invention is shown in FIG.

The preferred agglutination reaction judging container 1 has a reaction section 10 in its inner cavity, and a first judgment section 4 and a second judgment section 5 at the bottom of the reaction section 10. Above the first determination unit 4 and the second determination unit 5, a region 8 and a region 9 indicated by oblique lines are provided.
Exists. Here, when the agglutination reaction is performed in the main determination container 1, the particles included in the region 8 settle in the first determination unit, and the particles included in the region 9 settle in the second determination unit. The ceiling 2 is arranged such that the volumes of the regions 8 and 9 belonging to the first determination unit 4 and the second determination unit 5 are different from each other.
Heights are different.

The container of the present invention is made of glass, plastic,
And other various materials commonly used for containers. However, in order to observe the agglutination reaction, it is desirable that a part, particularly, a part located above and below the determination unit is light-transmissive. Also,
The present determination container may be composed of one member,
A plurality of members may be integrated.

The parameter used in the determination container 1 exemplified above is the volume belonging to the determination unit. In this way, two determination units having different parameters are arranged in one reaction system, and two data are obtained for one sample,
Accurate results can be obtained by comparing them with each other.

That is, it is possible to evaluate the authenticity of the obtained result by observing the aggregation patterns formed in all the judgment sections and comparing these data aggregation patterns. The final result, ie, positive or negative, is determined by considering this evaluation. If necessary, after evaluating the truth of the result, it is possible to repeat the analysis and evaluation under different conditions.

In the above example, the reaction regions 8 and 9
Although the height of the ceiling 2 is adjusted in order to adjust the volume of the determination unit, the position of the determination unit may be adjusted instead, so that the volume of the region belonging to each determination unit may be changed. However, when observing the coagulation reaction optically, it is preferable to adjust the volume by the ceiling 2 because the optical system can have a simple configuration.

In the above example, two judging sections are arranged in one reaction section, but more judging sections can be arranged. Further, a determination container array including a plurality of determination containers 1 may be used.

Further, as shown in FIG. 2, the inclination angles of the inclined surfaces of the judgment section 4 and the judgment section 5 may be different from each other. In this case, the volume may be changed by further changing the distance between the determination unit and the upper part of the determination container, or only the angle may be changed. By changing the inclination angle, the degree of rolling of the particles on the inclined surface changes. That is, the smaller the inclination angle, the slower the rolling, and the larger the inclination angle, the faster the rolling.

Also, as shown in FIG.
(See FIG. 3). As used herein, the term "terraced" refers to an object provided on an inclined surface at the bottom of the determination unit and having a plurality of steps regularly. Further, in the present determination container, when at least one portion of the bottom surface of the determination portion is a slope, a terraced may be provided on at least one portion of the slope (FIG. 4). A series of terraces of a plurality of types may be arranged at the bottom of one determination unit. The arrangement of the terraced makes it possible to provide a base layer capable of stably maintaining the settled particles on the inclined surface on the bottom surface of the determination unit. For example,
When there are many steps, or when there are many steps and the number of steps is large, it is easy to form a base layer that can more stably maintain settled particles on the inclined surface.

Although the cross section of the determination section is shown as V-shaped, it may be U-shaped. Also in the case of the U-shape, various changes such as changing the inclination angle and arranging the terraces can be added as in the case of the V-shape. Further, when the cross section of the bottom surface of the judging unit to be arranged is U-shaped,
By changing the radius of the ellipse that contains the character,
The shape of the determination unit may be changed. In addition, the bottom of the determination unit may not have a U-shape as a whole, but may have a U-bottom in at least a part of the bottom of the determination unit. In this case, the shape of the U bottom can be changed by changing the inclination or changing the radius of the ellipse including the U bottom as a part thereof.

In the V-shape and U-shape, the center is the lowest part. However, the shape of the bottom of the judgment unit is not limited to this, and the lowest part is located away from the center of the judgment unit. Such a shape (for example, a W shape or a mountain shape) may be used. In this case, the sediment tends to gather outside the center of the determination unit.

Further, in the above-described example, a plurality of judging sections are arranged in one reaction section. However, as shown in FIG. 5, one judging section is arranged in one reaction section, and a terrace is provided on a half of the bottom surface thereof. It is also possible to provide the determination container of the present invention by forming (FIG. 5). Similarly, one reaction section may be divided by a plane perpendicular to the bottom of the reaction vessel, and different inclination angles may be given to each other.

As an example of the use of the determination container 1 shown in FIG. 1, particles showing an agglutination image show the patient's erythrocytes 6 and the anti-B antibody 7, but these are only examples, and they are used according to the specimen and the reagent. Blood cells such as standard blood cells or animal blood cells, artificial particles, particles having a magnetic substance, or erythrocyte irregular antibodies, cell antigens such as platelets, lymphocytes, monocytes or granulocytes, or pathogens such as viruses or bacteria. Antigens, which are adsorbed to each other by immunological reaction.

The method of the present invention uses a determination vessel having a plurality of determination units in one reaction system. This allows for errors due to artifacts and dispensing accuracy caused by the dispensing operation and individual differences between patients. Erroneous determination resulting from inappropriate preparation caused by a disease or a disease can be prevented. In addition, since the reaction is performed in one reaction system, errors due to differences in reaction conditions can be prevented.

Further, since the judgment container of the present invention provides a large number of different information from a common mixed solution subjected to an agglutination reaction,
The reaction conditions are completely matched, and extremely accurate analysis becomes possible. In particular, in the case of using a judgment vessel in which a plurality of different parameters are mutually combined in a plurality of types necessary and sufficient, a plurality of reaction results corresponding to each of a plurality of necessary and sufficient judgment algorithms can be provided. Are obtained at once. On the other hand, a plurality of determination containers in which only a single parameter is independently varied (for example, a plurality of determination units in which only the angle of the bottom is only variously varied and only the depth of the bottom is only variously varied) May be arranged, but in this case, it is difficult to perform reliable verification and the determination time may be long.

Further, in the present invention, if a plurality of judging units are arranged in a sufficient setting range so that the dispensing error or individual variation for each patient always becomes an appropriate condition in one judging container, the present invention is different. There is no potential confusion when re-examining multiple patients at the right time.

Further, in another aspect of the present invention, the determination container has a plurality of different types of parameters (preferably two types).
Since the determination units are arranged in a matrix on coordinates obtained by two-dimensionally combining two or more conditions for each parameter, analysis of the determination result is easy. In particular, when performing determination by image measurement, the determination container There is an advantage that the coordinates of the above image information can be displayed as it is, and the data processing can be easily collated. Here, it is preferable to arrange a plurality of parameters on the coordinates so that the reaction conditions gradually increase or decrease, since the visibility of the determination result and the efficiency of data processing are improved.

[0038]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS First Embodiment A first embodiment will be described with reference to FIG. In the first embodiment, the agglutination reaction determination container 1 shown in FIG. 1 is used as a determination container. The details of the agglutination reaction determination container 1 are as described above. That is, the determination container 1 includes a first determination unit 4 and a second determination unit 5. The first determination unit 4 and the second determination unit 5 have the same bottom area, and the ceiling 2 has a higher height. Therefore, the volume of the region 9 is larger than that of the region 8.
The particles dispersed equally in the reaction section 10 of the main determination container 1 settle more in the second determination section 5 than in the first determination section 4. Using such a determination container 1, ABO is performed as follows.
Perform blood type hospitality test.

Erythrocytes of type A patients having type A antigenicity are simply prepared by common means. Further, the anti-B antigen, which is an antiserum, is diluted as necessary and mixed with the above-mentioned red blood cell preparation of the type A patient in an appropriate amount. This is dispensed into a determination container and allowed to stand. Subsequently, an aggregation pattern formed on the bottom surfaces of the first determination unit and the second determination unit due to natural sedimentation is observed. Here, the determination of the agglutination pattern is positive (+) if the red blood cells of the type A patient are distributed so as to spread over the entire determination area, and negative (-) if the red blood cells are distributed like a dot at the center. .
The results are summarized in Table 1.

[0040]

[Table 1]

As shown in Table 1, when the type A patient erythrocytes have a typical erythrocyte layer of about 50%, both the second determination unit and the first determination unit with more sedimented particles are negative. An aggregation pattern is obtained. However, in patients with a low ratio of erythrocytes, which are common in hemolytic anemia patients and dialysis patients, etc., the case of simple preparation from whole blood (and subsequent centrifugation), In a case where fractionation of red blood cells is insufficient due to viscosity, the first determination unit is positive. On the other hand, the second determination unit has a negative aggregation pattern. From these results, it is suggested that a sufficient result cannot be obtained if only the first determination unit determines.

2. Second Embodiment A second embodiment has the same configuration as that shown in FIG. 1 except that the bottom surfaces of the determination units 4 and 5 are V-shaped and the inclination angles are different between the two determination units. Use the same judging container. The bottom of the first determination unit 4 has a conventional inclination angle (θ ₁ ).
But the inclination angle (θ ₂ ) of the bottom of the second determination unit 5
Has a smaller inclination angle (θ ₁ <
θ ₂ ). That is, the second determination unit 5 has a gentler inclined surface than the first determination unit. An ABO blood type back test is performed using such a determination container as follows.

A standard blood cell B, which is a type B red blood cell used in the ABO blood type back test, and a type A patient serum containing an anti-B antibody, which is a natural antibody, are each prepared by a general method. These are respectively dispensed into the determination container, mixed, and allowed to stand. Observe the aggregation pattern formed on the bottom surface by natural settling. Determine the aggregation pattern. Here, the determination of the agglutination pattern is positive (+) if the distribution is distributed so as to spread over the entire standard blood cell B determination portion, and negative (-) if the distribution is like a dot at the center. Table 2 shows the results
I put together.

[0044]

[Table 2]

As shown in Table 2, when the type A patient serum (4) has strong antibody sensitivity, both the second determination portion having a gentle slope and the first determination portion having a steep slope are used together. A positive aggregation pattern is obtained. However, in the case of a patient having a low titer of natural antibody (that is, low sensitivity), which is said to have recently increased in the number of patients, the first judgment section is negative and the second judgment section is negative. A positive aggregation pattern is obtained in the judgment section of (1). From these results, it is suggested that a sufficient result cannot be obtained if only the first determination unit determines.

3. Third Embodiment In the third embodiment, except that the bottom surfaces of the determination units 4 and 5 are V-shaped, and the same number of terraces of different sizes are provided between the two determination units. Uses a determination container having the same configuration as that shown in FIG.

The terrace at the bottom of the first determination unit 4 is
The number of terraces is equal to the number of terraces at the bottom of the determination unit 5 but is small. That is, the second determination unit is more likely to form a stable base layer of the settled particles on the inclined surface than the first determination unit (here, if the terraced at the bottom of the second determination unit 5 is The same effect can be obtained even if the number of terraces is equal to the level of the terrace at the bottom of the first determination unit 4 and is greater than the number of terraces in the first determination unit. An ABO blood type back test is performed using such a determination container as follows.

A standard blood cell B, which is a type B red blood cell used in the ABO blood type back test, and a type A patient serum having an anti-B antibody as a natural antibody are prepared by conventional means.
Each of these is dispensed in an appropriate amount into the above-mentioned determination container, mixed, and allowed to stand. As a result, an aggregation pattern is formed on the bottom surface due to spontaneous sedimentation, which is observed.

The determination of the agglutination pattern is positive (+) if the standard blood cells B are distributed so as to spread over the entire determination area,
It is negative (-) if it is distributed like a point at the center. Table 3 summarizes the results.

[0050]

[Table 3]

As shown in Table 3, when the serum of type A patient has a high antibody sensitivity, both the second and the first judging units obtain an agglutination pattern that is positive. However, in the case of a patient having a low titer of a natural antibody (that is, a patient with low sensitivity) or the like, an agglutination pattern is positive in the second determination unit while negative in the first determination unit. From these results, it is suggested that a sufficient result cannot be obtained if the determination is made only by the first determination unit.

4. Fourth Embodiment In a fourth embodiment, as shown in FIG. 6, a determination vessel having nine determination units (ie, 1-A to 3-C) in one reaction unit is used. The nine determination units are managed by parameters I and II. The parameter I is managed by changing the volume, and the parameter II is managed by changing the inclination angle of the bottom surface of the determination unit. That is, as shown in FIG.
The volume of the reaction section region belonging to the determination section increases in the order of 1, 2, and 3. Similarly, the inclination angle of the bottom of the determination unit increases in the order of A, B, and C. Thereby, a difference can be given to the aggregation pattern in the nine determination units.

Here, the magnitude relation of these parameters may be reversed, but it is preferable to set them so as to increase or decrease gradually so as to facilitate analysis. However, preferably, conditions other than parameters to be combined,
For example, it is preferable that the size or shape of the bottom of the determination unit is the same. In addition, since the state of the agglutination reaction supplied to the plurality of determination units is also preferably uniform, all of the passages connecting the plurality of determination units have dimensions and shapes that allow uniform distribution regardless of the degree of aggregation. Preferably. However, it is preferable that all the communication passages in the determination container are naturally filled with all the determination portions by capillary force in a range where uniform distribution is possible. When the inside of the determination container is not spilled by the capillary force, the direction of the determination container is made vertical or inverted, so that stirring, measurement, and the like can be easily performed, so that operability is improved. In addition, as the number of parameters increases, the number of reaction sections and injection openings may be appropriately increased.

When such a determination container is used, and when a low-titer antibody is used as in the second embodiment, the number of negative images tends to increase in the (+) direction of FIG. When the number of particles is insufficient as in the first embodiment, the number of positive images tends to increase in the (-) direction of FIG. 6 as a whole.

By performing the aggregation determination in consideration of the above, it is possible to determine whether the obtained determination is a correct determination or whether the sample needs to be re-prepared. Therefore, a more accurate determination can be made.

The present invention is not limited to the above-described example, and various modifications are possible. For example, the number, size, and layout of the judging units of the judging container may be appropriately changed according to the capacity of the sample to be analyzed, the visibility at the time of judgment, or the ease of measurement. For example, by arranging a plurality of judging units two-dimensionally in a circular area or one-dimensionally arranging them on a line, it is possible to facilitate measurement by a circular field-of-view measuring means (for example, a CCD) or a linear scanner. Further, by making the vicinity of the opening of the determination container a size and a shape where the capillary force acts, a configuration may be adopted in which the liquid after injection is stably held in the determination container,
In this case, it is not necessary to provide the opening above.

The determination method of the present invention is a method for analyzing and evaluating an agglutination reaction using determination units having different parameters. Therefore, even for results in which it is difficult to determine both the aggregation pattern and the non-aggregation pattern, whether the aggregation pattern is weak due to a decrease in natural antibodies or whether the determination is substantially negative, there is a problem in dilution during sample preparation. It is possible to obtain data for fully examining whether the problem is due to contamination. As a result, it is possible to exclude individual differences between patients and errors in the sampling operation, and the determination result obtained by the present invention guarantees higher reliability than the conventional method. In addition, Du has a weak cohesive bond.
It is an object of the present invention to provide a method for determining the presence of a small amount of antibody with high accuracy even when only a small number of antibodies are present, such as in the case of a subtype or the like.

Note that the present invention is not limited to the above-described example, and various modifications are possible. For example, in the above-described embodiment, the immunological analysis by the antigen-antibody reaction is performed,
The present invention can be applied to a genetic analysis by a nucleic acid hybridization reaction of DNA or the like, and can be appropriately modified so as to apply the present invention to an analysis capable of obtaining a biological analysis result by an agglutination reaction.

[0059]

According to the present invention, a plurality of determination units determine the same type of reaction result for the same specimen or sample using different parameters, so that individual differences between patients and errors in sampling operation are excluded. Reliable and accurate biological analysis becomes possible.

[Brief description of the drawings]

FIG. 1 is a diagram showing an agglutination reaction determination container according to a preferred embodiment of the present invention.

FIG. 2 is a sectional view of a determination unit.

FIG. 3 is a sectional view of a determination unit.

FIG. 4 is a sectional view of a determination unit.

FIG. 5 is a view showing a preferred determination container of the present invention.

FIG. 6 is a plan view of a determination container according to a preferred embodiment of the present invention and a diagram showing parameters.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Judgment container, 2 ... Ceiling, 3 ... Opening part, 4 ... First judgment part, 5 ... Second judgment part, 6 ... Type A patient red blood cell, 7 ... Anti-B
Antibody, 8: first region, 9: second region, 10: reaction part.

 ──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 2G052 AA30 AB16 AD06 AD26 AD46 BA02 CA18 CA39 CA40 DA06 DA12 ED16 FB02 FB07 GA30 HB10 HC32 HC38 JA09

Claims (13)

[Claims] 1. A method for analyzing and evaluating an agglutination reaction in a determination vessel having a plurality of determination sections at the bottom of one reaction section, wherein the plurality of determination sections have mutually different parameters, and (A) causing a sample and a reagent to be present in the determination container to perform an agglutination reaction; (b) allowing the determination container to stand still; and (c) observing an aggregation pattern in all the determination units, and A method for analyzing and evaluating an agglutination reaction, comprising analyzing and evaluating the agglutination reaction by comparing these agglutination patterns. 2. The method for analyzing and evaluating an agglutination reaction according to claim 1, wherein the volumes of the reaction units belonging to each of the plurality of determination units are different from each other. how to. 3. The method for analyzing and evaluating an agglutination reaction according to claim 1 or 2, further comprising analyzing at least one of the plurality of judging sections in a shape different from each other. How to evaluate. 4. The method for analyzing and evaluating an agglutination reaction according to any one of claims 1 to 3, wherein at least a part of the bottom of the determination unit has an inclined surface, and between the determination units. A method for analyzing and evaluating an agglutination reaction, characterized in that the inclined surfaces have different inclination angles. 5. The method for analyzing and evaluating an agglutination reaction according to claim 1, wherein at least a part of the bottom of the determination unit has a slope, and a plurality of slopes are provided on at least one part of the slope. A method for analyzing and evaluating an agglutination reaction characterized by having a step of: 6. The method for analyzing and evaluating an agglutination reaction according to any one of claims 1 to 5, wherein at least a part of the plurality of determination unit bottoms has a U bottom, and the U bottom is provided. A method for analyzing and evaluating an agglutination reaction, wherein the radius of an ellipse partially including a U-shape that is a cross-sectional shape is different between judgment portions. 7. The method for analyzing and evaluating agglutination according to any one of claims 1 to 6, wherein the specimen or sample contains particles, and the particles are blood cells or particles having magnetism. A method for analyzing and evaluating an agglutination reaction, characterized in that: 8. The method according to claim 7, wherein the blood cells or particles having magnetism are blood cells or particles having magnetism sensitized with an immunological substance. 9. The method according to claim 1, wherein the immunological agglutination is a front or back test of a blood type test, a Rh-type blood type test, a Du test, a blood cell type test, or a mixed passive agglutination method. A method for analyzing and evaluating the agglutination reaction according to any one of the preceding claims. 10. An agglutination reaction determination container having a plurality of determination sections at the bottom of one reaction section, wherein the volumes of the reaction sections belonging to each of the plurality of determination sections are different from each other. 11. A method in which a plurality of determination units accommodating the same liquid to be determined are configured to be a combination of a plurality of conditions corresponding to a plurality of parameters, and are arranged on two-dimensional coordinates. An agglutination reaction determination container characterized by the following. 12. The coagulation judging container according to claim 11, wherein the plurality of parameters are arranged on coordinates such that the reaction conditions gradually increase or decrease. 13. The agglutination judging container according to claim 11, wherein a combination of a plurality of conditions is within a set range sufficient to eliminate variations in reaction conditions.