JPH0248864B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention relates to a clinical test plate used for serological or immunological tests. Serological or immunological tests are performed using agglutination reactions caused by antigen-antibody reactions.
Examples include red blood cell agglutination, latex agglutination, carbon agglutination, and silica agglutination. These use red blood cells, latex, carbon, silica, etc. as carriers, and antigens or antibodies are adsorbed or bound to the carrier surface in advance, and sample serum is mixed with this on a clinical test plate. By observing the agglutination reaction, it is determined whether antibodies or antigens that specifically react with the antigens or antibodies adsorbed or bound to the surface of the carrier are present in the sample serum at a level exceeding a certain standard value. . Sensitivity in agglutination reactions based on antigen-antibody reactions,
Specificity is greatly influenced by the surface condition of the carrier, especially the adsorption and binding condition of antibodies or antigens, but it has been found that the surface condition of the plate on which the sample serum is mixed has a considerable influence as well. The properties that a plate for clinical testing should have include not swelling or absorbing water, being water resistant, having appropriate water wettability, not inhibiting antigen-antibody reactions, and being in an agglutinated state. For example, it is easy to observe. Glass plates have been used in conventional clinical test plates, but the disadvantages of glass plates are that they are easily broken and difficult to process, such as coloring, making it difficult to observe the state of aggregation. In view of the above points, the present inventors have conducted various studies on improving plates for clinical testing, and as a result, have completed the present invention. The gist of the present invention is that a hydrophilic substance that has surface migration properties and is hardly soluble or insoluble in water is contained in an opaque synthetic resin base material, has a flat surface, and is resistant to liquids. The present invention resides in a clinical test plate characterized by improved droplet spreading properties. Next, the clinical test plate of the present invention will be explained in more detail. Examples of synthetic resins constituting the base material include polystyrene, polymethyl methacrylate, polyvinyl chloride, polycarbonate, and acrylonitrile.
Styrene copolymer, styrene-maleic anhydride copolymer, acetyl butyl cellulose, butyralized polyvinyl alcohol, polypropylene, polyethylene, poly-4-methylpentene-1, ethylene-propylene copolymer, polyethylene terephthalate, polybutylene terephthalate, etc. are preferable, and a mixture of a plurality of these types may be used. Then, a water-insoluble coloring agent such as carbon black is mixed into the synthetic resin, and the base material obtained by molding is colored and made opaque. The amount of the colorant used is preferably 1 part by weight or more per 100 parts by weight of the synthetic resin constituting the base material. Furthermore, the synthetic resin may contain water-insoluble fillers, stabilizers, and the like. The base material used is one having a flat surface, that is, one formed into a film shape, sheet shape, plate shape, or the like. The synthetic resin base material contains a hydrophilic substance that has surface migration properties and is hardly soluble or insoluble in water.
Having surface migration properties means having the property of migrating from the inside of a synthetic resin base material to the surface over time, and when mixed with a synthetic resin and molded into a base material, the base material migrates from the inside over time. This is the case when it oozes out onto the surface of the material. Specifically, poorly soluble or insoluble in water means that the solubility in 100 g of water at 20° C. is 5 g or less. Examples of such hydrophilic substances include glycerin monostearate, glycerin monooleate,
There are partially esterified products of polyhydric alcohols such as sorbitan monostearate, sorbitan monooleate, pentaerythritol monostearate, and alkyl esters of sucrose, especially those with a molecular weight of 500.
The following glycerin monostearate, glycerin monooleate, sorbitan monostearate,
Sorbitan monooleate and the like are suitable for use. The synthetic resin base material contains hydrophilic substances that have surface migration properties and are poorly soluble or insoluble in water, as well as hydrophilic substances that have poor surface migration properties and are poorly soluble or insoluble in water. It's okay. Poor surface migration means that it does not exhibit the property of migrating from the inside of the synthetic resin base material to the surface over time, or only exhibits a property of migrating to the surface. Examples of such hydrophilic substances include polyethylene oxide, polyvinylpyrrolidone, partially saponified polyvinyl acetate, partially acetalized polyvinyl alcohol, cellulose, cellulose acetate, methylcellulose, ethylcellulose, hydroxypropylcellulose, polyacrylic acid, and polyglycerin. There are partially esterified products of polyethylene oxide and polyglycerin with a molecular weight of 500 or more, and particularly suitable for use are partially esterified products of polyethylene oxide and polyglycerin with a molecular weight of 800 to 2000. The hydrophilic substance that has surface migration properties and is poorly soluble or insoluble in water is preferably used in a proportion of 0.2 to 10 parts by weight per 100 parts by weight of the synthetic resin constituting the base material. The hydrophilic substance that has poor migration properties and is poorly soluble or insoluble in water has the above-mentioned surface migration properties and is contained in a proportion of 0.1 to 10 parts by weight per 1 part by weight of the hydrophilic substance that is poorly soluble or insoluble in water. It is suitable for use in Note that a support layer made of paper, metal, wood, etc. may be provided on the back side of the synthetic resin base material. Further, the surface of the synthetic resin base material can be printed if necessary. The clinical test plate of the present invention has surface migration properties contained in the synthetic resin base material,
Hydrophilic substances that are poorly soluble or insoluble in water migrate to the surface of the synthetic resin base material and form a hydrophilic thin film, so when performing serological or immunological tests using antigen-antibody reactions, Even when the test liquid or sample serum is dropped onto the surface, swelling, absorption, etc. do not occur, and a preferable spread occurs. Furthermore, since the hydrophilic substance in the synthetic resin base material is water-insoluble, it does not inhibit the antigen-antibody reaction even if it migrates to the surface. Therefore, the use of the clinical test plate of the present invention has advantages such as excellent sensitivity in agglutination tests and less possibility of non-specific agglutination reactions. The clinical test plate of the present invention can be applied to all clinical tests that utilize the agglutination reaction between antigen and antibody, such as C-reactive protein (CRP) test, anti-streptolysin O value (ASLO) test. ,
Rheumatoid factor (RA) test, antinuclear antibody (LE) test, thyroid autoantibody (TA) test, syphilis test,
ABO blood grouping test, Rh blood grouping test, blood crossmatch test, immunoglobulin (IgG, A,
M, D) Suitable for use in measurement tests, etc. Example 1 A composition containing 100 parts by weight of polystyrene, 5 parts by weight of glycerin monostearate, and 1.5 parts by weight of carbon black was used and extruded to obtain pellets. By injection molding using this pellet, the length is 130m/m, the width is 45m/m, and the thickness is 1m/m.
An opaque, black clinical test plate with a smooth surface was obtained. Using this plate, an RA test for detecting rheumatoid factor was performed using an RA kit. Transfer 1.0ml of glycine saline buffer to a small test tube.
One drop (0.05 ml) each of negative and positive serum was added to this and mixed well. One drop (10μ) of each of these diluted sera was then added to separate compartments of a clinical test plate. Furthermore, one drop (10μ) of a reagent made of polystyrene latex adsorbed with human denatured γ-globulin was added to each compartment, mixed well with serum, and the droplet was spread into a circle with a diameter of 25 m/m. Lift this clinical test plate with both hands and
After moving it gently for about a minute, it was left to stand and was judged with the naked eye. In this clinical test plate, as shown in the column of Example 1 in Table 1, the droplets spread well, the aggregates in positive serum appear quickly, and a clear agglutination image can be obtained. Ta. Examples 2 to 3 A composition (Example 2) in which 100 parts by weight of polystyrene was blended with 3 parts by weight of glycerin monostearate, 2 parts by weight of polyethylene oxide (molecular weight 1500), and 2.5 parts by weight of carbon black, and 100 parts by weight of polystyrene. A composition (Example 3) containing 3 parts by weight of glycerin monostearate, 2 parts by weight of pentaglycerin monostearate, and 2.5 parts by weight of carbon black was used in Example 1.
A clinical test plate was formed in the same manner as in Example 1, and RA for rheumatoid factor detection
I did a test. As shown in the columns of Examples 2 and 3 in Table 1, each plate for clinical testing has good droplet spreadability, the appearance of aggregates in positive serum quickly, and clear images of agglutination. It was done. Comparative Example 1 A composition containing 100 parts by weight of polystyrene and 1 part by weight of carbon black was used, and the length was 130 m/m, the width was 45 m/m, and the thickness was 1 m/m by injection molding.
A smooth plate was formed. Using this plate, an RA test for detecting rheumatoid factor was conducted in the same manner as in Example 1. In the Comparative Example column of Table 1, the droplet spreadability was poor, the appearance of aggregates in positive serum was slow, and the agglutination image was unclear.

[Table] Agglutination determination time refers to the time required to obtain a determinable agglutination image.

Claims (1)

[Claims] 1. A synthetic resin base material made opaque, containing a hydrophilic substance having surface migration properties and hardly soluble or insoluble in water, and having a flat surface; A plate for clinical testing that is characterized by improved droplet spreadability. 2. The clinical test plate according to claim 1, further containing a hydrophilic substance that has poor surface migration and is poorly soluble or insoluble in water.