JPH062226U - Inspection plate - Google Patents

Abstract

(57) [Summary] [Purpose] To obtain a test plate capable of accurately determining the presence or absence of an agglutination state even in a low-concentration sample in a short time. [Structure] An elliptic ring closed loop-shaped bank 3 is formed by printing a hydrophobic ink on a surface of a base material 2 of which at least one surface is made of a synthetic resin, and the area inside the bank 3 is formed by printing a hydrophobic ink. As an inspection section, the inner peripheral edge 3 of the bank 3
An inspection plate 1 having at least one convex portion 4 formed so as to project from a toward the inspection portion.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to an inspection plate, and more particularly, to an improvement in the structure of an inspection plate in which a closed-loop bank is formed on the surface of a base material and an area inside the bank is used as an inspection section.

[0002]

[Prior art]

 Conventionally, when performing serological or immunological tests in clinical tests and the like, test plates utilizing agglutination reaction due to antigen-antibody reaction have been used. As this type of inspection plate, conventionally, plates having various structures have been proposed. For example, in Japanese Utility Model Publication No. 2-45814, a silicon dioxide vapor deposition layer is provided on the surface of a base material made of a synthetic resin film such as a polyester film, and a closed loop-shaped hydrophobic bank is formed on the vapor deposition layer. An inspection plate in which an area inside the bank is used as an inspection unit is disclosed. In this prior art, the surface of the inspection portion is made hydrophilic by the vapor deposition layer made of silicon dioxide.

In Japanese Utility Model Publication No. 2-45816, a bank is formed by printing a hydrophobic ink mixed with wax in a closed loop shape on the surface of a hydrophilic film, and an area inside the bank is formed. An inspection plate as an inspection unit has been proposed. In this inspection plate, since the bank is made of wax-containing hydrophobic ink, outflow of the sample, the reagent or the reaction liquid of these from the inspection section is effectively prevented.

In Japanese Utility Model Publication No. 2-45817, a bank is formed by thickly printing a hydrophobic ink in a closed loop on the surface of a hydrophilic hydrophilic film to form a bank, and the area inside the bank is formed. As an inspection part, an inspection plate is proposed in which only the area outside the bank is matted. This inspection plate gives gloss to the inspection part and makes it easy to observe the reaction results between the sample and the reagent. On the other hand, the area outside the bank is matted to suppress light reflection, and the inspection result I try not to interfere with my observation.

[0005]

[Problems to be solved by the device]

 In each of the various conventional inspection plates described above, a bank is formed by printing hydrophobic ink in a closed loop shape on the surface of a base material made of a hydrophilic film or the like, and the area inside the bank is inspected by an inspection unit. I am trying. This closed-loop embankment is in the shape of a ring or an ellipse, and when used, the specimen and the reagent were mixed in the inspection section and the presence or absence of aggregation was observed. In this case, in order to make the mixing of the sample and the reagent smoother, the test plate is swung back and forth and left and right, and the reaction solution in the test section is moved along the inner edge of the bank to separate the sample and the reagent. It was mixed.

However, with the conventional test plate, it is difficult to accurately determine the presence or absence of aggregation when the concentration of the sample is low. That is, in the case of a low-concentration sample, since the degree of agglutination was low, it was not possible to accurately determine the presence or absence of agglutination, and the agglutination state was sometimes overlooked, giving erroneous test results. In addition, a low-concentration sample must be reacted with the reagent for a long time.In that case, a part of the reagent dries and adheres to the inner edge of the bank during the test, and the dried and adhered reagent is mixed again. It may be mixed in the reaction solution. As a result, the mixed reagent may have an appearance similar to the agglutination state of the sample and the reagent, and may give an erroneous test result.

An object of the present invention is to provide a test plate that enables accurate and short-time determination of the state of aggregation of a sample and a reagent even when testing a low-concentration sample. It is in.

[0008]

[Means for Solving the Problems]

 The present invention comprises a base material having at least one surface made of a synthetic resin, and a closed-loop embankment formed on the surface of the synthetic resin and made of hydrophobic ink and having a circular or elliptic ring shape. An inspection plate in which an area inside the bank is an inspection section, the inspection plate having at least one protrusion formed so as to project from the inner peripheral edge of the bank toward the inspection section. It is a plate. Hereinafter, the details of the configuration of the present invention will be described.

In the inspection plate of the present invention, a base material having at least one surface made of synthetic resin is used. That is, the base material may be entirely made of a synthetic resin film, a synthetic resin sheet, or a synthetic resin plate, or may be a laminated material of a member other than synthetic resin such as paper and a synthetic resin material. May be.

As the synthetic resin forming the at least one surface, a synthetic resin that does not affect the sample and the reagent can be used. Examples of such synthetic resins include polyethylene-based, poly-α-olefin-based, polyhalogenated vinyl-based, polyamide-based, polyester-based, polystyrene-based, polycarbonate-based, polyacrylic acid ester-based, polyvinyl alcohol-based, and cellulose derivatives. Examples thereof include polymers. Above all, in order to effectively react the liquid reagent and the specimen, the surface of the above synthetic resin is preferably hydrophilic. Therefore, polyvinyl alcohol or a synthetic resin obtained by crosslinking polyvinyl alcohol by an appropriate method (for example, Bob Ron (registered trademark, manufactured by Nippon Synthetic Chemical Industry Co., Ltd.), a stretched polyvinyl alcohol film known by the trade name), or one having a hydrophilic layer such as a vapor deposition layer of silicon dioxide formed on its surface, or a synthetic resin such as polystyrene resin. It is preferable to use a substrate whose surface is treated with plasma to impart hydrophilicity.

The surface of the base material made of synthetic resin may be colored so as to exhibit a dark color such as black in order to facilitate observation of the aggregated state. The closed-loop bank having the above-mentioned annular or elliptical ring shape is composed of a hydrophobic ink, but this hydrophobic ink does not affect the sample and reagent and has a good hydrophobicity. Any material can be used as long as it is shown.Examples of such hydrophobic ink include polyester or polyvinyl chloride as a binder, to which pigments, waxes and other additives are mixed. What is done is used.

In order to form the bank, the hydrophobic ink is printed so as to have a certain thickness. However, the height of the embankment is determined by the amount of the sample and reagent put in the inspection section, the area of the inspection section, etc. Therefore, the height of the bank made of hydrophobic ink is uniquely determined. Absent. Usually, the bank is formed by printing the hydrophobic ink in a thickness of about 5 to 10 μm.

A feature of the inspection plate of the present invention is that at least one convex portion formed so as to protrude from the inner peripheral edge of the bank toward the inspection portion is provided. In the present invention, by providing the convex portion, the reaction liquid circulating in the inspection unit collides with the side wall of the convex portion, whereby the aggregate is easily retained on the side wall of the convex portion. Therefore, even with a low-concentration sample, the agglutination state can be observed accurately in a shorter time.

Since the convex portion is provided in order to facilitate the determination of the aggregated state by accumulating the aggregate as described above, the height of the convex portion is the same as that of the bank. Alternatively, it may be formed at a height different from that of the bank. However, in actual manufacturing, it is efficient to form the protrusions with the hydrophobic ink at the same time as the embankments, so that the protrusions are usually at the same height as the embankments.

Further, the convex portion acts not only to make the aggregates stay and facilitate the determination of the aggregation state, but also to promote the mixing of the reaction liquid in the inspection unit. Therefore, it is preferable that the convex portion is formed in a shape and a size that do not prevent mixing of the reaction liquid in the inspection portion. Generally, the inspection part is an ellipse having a major axis of 30 to 40 mm and a minor axis of about 20 to 30 mm or a circle having an area equivalent to this. In this case, in order to exert the action of the convex portion as described above, the length along the inner peripheral edge of the embankment of the portion of the convex portion that is continuous with the embankment is about 2 mm to 15 mm, and the tip of the convex portion and the inner part of the embankment The distance from the peripheral edge is about 2 mm to 8 mm. When forming multiple convex parts, the total length of the part of the entire convex part that is continuous with the inner peripheral edge of the bank along the inner peripheral edge of the bank is 2 to 20% of the total circumference of the inner peripheral edge of the bank. It is preferable to form it so as to be within the range. Furthermore, in order not to impede the mixing effect in the inspection portion, it is not preferable that the tip of the convex portion protrudes too deeply into the inspection portion, and therefore, it is preferable that the tip is not formed near the center of the inspection portion.

The planar shape of the convex portion may be any shape such as a semicircular system, a triangular shape, or a rectangular shape, but it is preferable that the convex portion has a rounded tip. This is because the roundness at the tip facilitates the movement of the reaction solution in the inspection section and promotes mixing. For the same reason, it is also preferable that the lower end portion of the side wall of the convex portion, which is continuous with the bank, has a slightly rounded shape.

[0017]

[Action]

 In the inspection plate of the present invention, at least one convex portion is formed so as to project from the inner peripheral edge of the bank toward the inspection portion as described above. Therefore, the reaction liquid rotating in the inspection unit collides with the side wall of the convex portion, and the aggregate is easily retained in the vicinity of the side wall of the convex portion. Therefore, even when testing a low-concentration sample, it is possible to reliably and reliably determine the aggregation state in a short time. Further, the above-mentioned convex portion exerts a turbulent flow effect on the reaction liquid circulating along the inner peripheral edge of the bank, and therefore acts to promote the mixing of the reaction liquid. Therefore, when a low-concentration sample is examined, the reaction time can be shortened.

[0018]

【Example】

 Hereinafter, the present invention will be clarified by describing embodiments of the present invention with reference to the drawings. 1 is a plan view showing an inspection plate according to a first embodiment of the present invention. In the inspection plate 1, an oval ring-shaped bank 3 is formed on the surface of the base material 2 by printing hydrophobic ink. Further, two protrusions 4 are formed so as to protrude inward from the inner peripheral edge 3a of the bank 3.

The base material 2 is formed by bonding a stretched polypropylene film on the lower surface of cardboard and a polyvinyl alcohol film on the upper surface, and the bank 3 is printed on the upper surface side. The bank 3 and the convex portion 4 are formed by screen-printing a hydrophobic ink using polyester as a binder, and the convex portion 4 has a chevron shape with a rounded tip as illustrated. Further, a portion of the lower end portion of the side wall of the convex portion 4 which is continuous with the bank 3 is also slightly rounded.

In the inspection plate 1 of the present embodiment, since the convex portion 4 is projected inward from the inner peripheral edge 3a of the bank 3 as described above, the inspection portion is schematically shown in FIG. When the reaction liquid of the reagent and the sample moves in the directions of arrows A to C within 5, aggregates stay in the vicinity of the side wall 3a of the convex portion 3. Therefore, even in the case of testing a low-concentration sample, the aggregation state can be accurately determined in a short time. Not only that, as is clear from the arrows B and C, the reaction liquid moving on the inner peripheral edge of the bank 3 is more efficiently stirred in the inspection unit 5 due to the presence of the convex portion 4. The reaction time between the sample and the reagent can be shortened. In the first embodiment, the convex portion 4 is configured to have a chevron-shaped planar shape with a rounded tip. However, in the convex portion of the present invention, as shown in FIGS. The shape of can be variously changed.

In the inspection plate 6 of the second embodiment shown in FIG. 3, the convex portion 7 is shaped so that its outer edge draws an arc. Further, in the inspection plate 8 of the third embodiment shown in FIG. 4, the convex portion 9 is configured to have a triangular shape. In addition, in FIG. 1, FIG. 3 and FIG. 4, one inspection plate 5 is provided on each of the inspection plates 1, 6 and 8; A plurality of inspection units 5 may be configured. Further, the planar shape of the bank 3 does not necessarily have to be an elliptical ring shape as shown in the figure, and may be formed in an annular shape. Not only the number of projections to be formed is not limited to that shown in the figure, and at least one projection may be formed. Next, a specific experimental example will be described.

Aggregation test 1 1 ml of polystyrene latex having a particle size of 0.38 μm (manufactured by Sekisui Chemical Co., Ltd., solid content concentration 10% by weight) was dispersed in 10 ml of a glycine buffer solution having a pH of 8.5, and the dispersion liquid 1 was prepared. The volume was mixed with 1 solution of human gamma globulin solution diluted to 0.1% by weight with glycine buffer pH = 8.5 and kept at a temperature of 37 ° C. for 60 minutes. Then, the above mixture was centrifuged at 15,000 rpm for 20 minutes with a centrifuge (himac CR20B3, manufactured by Hitachi, Ltd.) to remove human gamma globulin not adsorbed on the latex particles, and then the precipitated latex. The particles were again pH = 8. 5 ml of glycine buffer was dispersed to obtain 10 ml of a uniform sensitized latex dispersion, which was used as a latex reagent.

20 μl of the latex reagent prepared as described above and 20 μl of human serum containing rheumatoid factor diluted with glycine buffer solution of pH = 8.5 at various ratios were added to the above-mentioned first example. The mixture was mixed on the inspection plate 1, and the inspection plate was gently tilted back and forth and right and left for 3 minutes to visually observe the strength of the agglutination reaction. In addition, the width of the bank 3 in the used inspection plate 1 is 2 mm, and the inspection part 5 has a major axis of 35 mm and a minor axis of 26 mm. In addition, the convex portion 4 has a dimension a (a length dimension along the inner peripheral edge of a portion connected to the inner peripheral edge of the bank) of 5 mm and a dimension b (distance between the front end and the inner peripheral edge of the bank) of 4 mm in FIG. It is formed to the size of.

For comparison, a conventional inspection plate 10 shown in FIG. 5 was prepared, and an aggregation test was conducted in the same manner as above. The inspection plate 10 of this comparative example has the same structure as that of the first embodiment except that the convex portion 4 is not formed. The results of the aggregation test are shown in Table 1 below.

[0025]

[Table 1]

In Table 1, the evaluation symbols indicating the aggregation state have the following contents. ++: Extremely strong aggregation +: Clearly visible aggregation ±: Weak aggregation −: No aggregation

As is clear from Table 1, when the test plate of the comparative example was used, only weak aggregation was observed in the sample having a dilution ratio of human gamma globulin of 320 times, and aggregation was observed in the sample diluted to 640 times or more. Was not observed. On the other hand, when the test plate of the first embodiment was used, a clear aggregation state could be observed at a dilution ratio of 320 times. In addition, it was possible to determine aggregation even when the dilution ratio was 640 times.

Agglutination test 2 20 μl of the latex reagent used in the agglutination test 1 and 20 μl of the sample prepared in the agglutination test 1 with a dilution ratio of 640 times were prepared in the agglutination test 1 for the test of the first embodiment. Then, the reaction was allowed to proceed on the test plate of the comparative example, and the progress of aggregation until 3 minutes later was visually observed. The results are shown in Table 2 below.

[0029]

[Table 2]

The evaluation symbols for aggregation in Table 2 have the same contents as the evaluation symbols for aggregation shown in Table 1. As is clear from Table 2, in the test plate of the comparative example, no aggregate could be observed even after reacting for 3 minutes, whereas in the test plate of the first example, 120 seconds passed. It was possible to determine the presence or absence of aggregation at the stage.

Agglutination test 3 In order to confirm the influence of the change in the shape of the convex portion, 20 μl of the latex reagent used in agglutination test 1 and 20 μl of the sample prepared in agglutination test 1 at a dilution ratio of 320 times were prepared as follows. The plate was reacted for 3 minutes on each of the test plates of plate numbers 1 to 10 shown in Table 3 above.

As shown in FIG. 6, all the inspection plates of the inspection plate numbers 1 to 8 shown in Table 3 have an elliptical ring-shaped bank (inner part) with an inner peripheral edge having a major axis of 35 mm and a minor axis of 26 mm. This is a test plate in which one chevron-shaped convex portion 11 is formed on the inner side with a peripheral edge distance of about 90 mm). Then, the dimension a in the figure, that is, the length dimension along the inner peripheral edge 3a of the portion of each convex portion 11 which is continuous with the inner peripheral edge 3a of the bank 3, and the dimension b, that is, the tip of the convex portion 11 to the inner peripheral edge 3a of the bank 3 And the distance to were changed as shown in Table 3. As for plate number 9, a plate-shaped convex portion having the dimensions a and b shown in Table 3 was formed at two locations as in the first embodiment shown in FIG. Therefore, in the inspection plate of plate number 9, a total of 7. The ratio of the total length of the inner peripheral edge 3a of the bank 3 of 5 × 2 = 15 mm to the total length of 90 mm is 16.6%.

The plate number 10 is the inspection plate of the comparative example, and is configured in the same manner as the inspection plates of the plate numbers 1 to 9 except that the convex portion 11 is not formed. . The results of the agglutination test using each of the above inspection plates are also shown in Table 3.

[0034]

[Table 3]

As is clear from Table 3, in all of plate numbers 1 to 9 corresponding to the inspection plates of the examples, aggregation was clearly observed, whereas in the plate of the comparative example in which no convex portion was formed. Only weak aggregation was observed. Also, as is clear from Table 3, in the inspection plates of plate numbers 1 to 8 in which one convex portion is formed, even if the dimensions a and b of the convex portion are changed as described above, the same aggregation determination is performed. The results were obtained, and as is clear from the result of the test plate of plate number 9, even when two convex portions are formed, it is possible to easily observe the aggregation for the specimen having a dilution ratio of 320 times. Recognize.

[0036]

[Effect of device]

 As described above, in the inspection plate of the present invention, at least one convex portion is formed so as to project from the inner peripheral edge of the bank toward the inspection portion. The aggregation state can be accurately determined in a short time. Therefore, the accuracy of the test in the clinical test can be improved, and the test time can be shortened.

[Brief description of drawings]

FIG. 1 is a plan view showing an inspection plate of a first embodiment.

FIG. 2 is a schematic partial enlarged plan view for explaining the action of a convex portion in the first embodiment.

FIG. 3 is a plan view of an inspection plate according to a second embodiment.

FIG. 4 is a plan view of an inspection plate according to a third embodiment.

FIG. 5 is a plan view showing a conventional inspection plate.

FIG. 6 is a plan view of an inspection plate prepared in agglutination test 3.

[Simple explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Inspection plate 2 ... Base material 3 ... Bank 3a ... Inner peripheral edge 4 ... Convex part 5 ... Inspection part

Claims (1)

[Scope of utility model registration request] 1. A closed-loop bank having at least one surface made of a synthetic resin, a bank formed on the surface of the synthetic resin and made of a hydrophobic ink, and having a circular ring shape or an elliptical ring shape, An inspection plate in which an area on the inside of the bank is an inspection section, having at least one convex portion formed so as to project from an inner peripheral edge of the bank toward the inspection section, Inspection plate.