JPH0763750A - Container for diagnosis - Google Patents

Abstract

PURPOSE:To provide a container for diagnosis which can be easily operated, can hygienically give discrimination results, and can keep a reaction product for a long period and with which the completion of a reaction can be surely confirmed. CONSTITUTION:A container for diagnosis has an inspecting tool main body 1 equipped with a filtering section 8 containing a detection reagent, discrimination sheet 14 to which a reactive reagent is adhered, discrimination plate 9 for fixing the sheet 14, indicator for confirming the completion of a reaction, and water absorbing body 13, stick 10 which can be separated from the main body 1 and can be impregnated with a specimen, and a projecting section for pressing the front end section of the stick 10.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a diagnostic container, and more particularly to a diagnostic container suitable for diagnosing pregnancy, ovulation and the like.

[0002]

2. Description of the Related Art Conventionally, in a urine test such as a mass examination,
Urine sample collected by a patient in a container such as a cup, or
As described in JP-A-59-40256, a qualitative or semi-quantitative test is conducted by directly immersing a test paper in a urine sample that has accumulated in the hollow part of the toilet bowl. When a test cannot be performed and a detailed test is required, a urine sample is transported and tested in a clinical laboratory.

[0003] In general, a method is used in which a urine sample collected in a cup is dispensed into a small transport container by a spoid or the like, and the urine sample is transported to a clinical laboratory to examine urine.

However, when the urine is collected from a clinical laboratory, since the urine sample is in a liquid state, various bacteria in the sample grow during transportation, and the measurement result in the test for protein, glucose, etc. There was a problem that could not be obtained accurately.

Further, there is a method of inspecting by causing an agglutination reaction or a color reaction in a liquid reagent solution, but all of them have a drawback that the reaction result is difficult to maintain because they are reactions in a liquid phase. .

In order to solve these problems, a permeation system has been invented, in which urine is dropped on a test device main body having a test piece having a moisture absorber laid inside, and a judgment is made by an antigen-antibody reaction and an enzyme reaction. Since there are several operations such as dropping the necessary reagent components separately with a dropper, the operation is complicated, it takes time to measure, and accurate results can be obtained by mixing the previously dropped reagents and samples. There was nothing. Also, if left for a long time, since the moisture absorber and the test piece are integrated, the excess moisture once absorbed by the moisture absorber returns to the test piece over time,
After all, it had a drawback that the reaction result could not be maintained. Therefore, when the operator and the judge are different or the number of samples is large, the color developing agent in the diagnostic agent may fade over time or the color image at the time of judgment may change because the vicinity of the judgment part is always wet. There was a problem that it was not clear and accurate judgment was not possible.

On the other hand, in the case of the chromatographic method, the sample collection is completed by a simple operation in which a urine sample is applied to a part of the test device, but the time required for the reaction is long and the part to which urine is applied is long and slender. In many cases, it is difficult to apply urine, and there is a problem that urine scatters when collecting urine and covering the collection area is still unsanitary. Also, during the development of chromatography, the judgment part may be colored and misleading, and the color of the judgment part and the part that indicates the end of the reaction may be the same color, so it may be confusing whether it is the judgment or the end of the reaction. there were.

[0008]

SUMMARY OF THE INVENTION The present invention has been made in view of the above problems, and 1) All the reagents and the sample collecting section necessary for the determination are incorporated in the test tool body. 2)
Widen the surface of the sample collection part and take out the stick separately from the inspection tool body. 3) Provide an indicator that changes color after a certain period of time and a window for checking the indicator color.
4) The determination part and the water absorber can be separated. It is therefore an object of the present invention to provide a diagnostic container which can easily collect a sample, can be processed hygienically, can store a reaction result for a long period of time, and can surely confirm the completion of the reaction.

[0009]

SUMMARY OF THE INVENTION The present invention comprises a stick that can be impregnated with a sample at its tip and a main body of an inspection tool that accommodates this stick. The main body of the inspection tool is composed of an upper box body and a lower box body. The box body has a convex portion that presses the tip of the stick, and the lower box body is attached with an inner case on which the stick is placed, and the convex portion presses the tip of the stick on the inner case. A filtering part containing a labeled antibody for detecting an antigen by an antigen-antibody reaction is fixed at a position where the determination plate has a sheet part containing an antibody that reacts with the antigen under the filtering part. A gist of the present invention is a diagnostic container, which is arranged so that it can be inserted into and removed from a main body, and a moisture absorber is laid between a determination plate and a bottom portion of a lower box body.

In the present invention, the box body constituting the main body of the inspection tool body, the inner case, and the convex portion is polyvinyl chloride,
A synthetic resin such as polyethylene, polypropylene, polyester, polyamide, polycarbonate, and acrylic resin is used alone or in combination.

In the present invention, the filtering part is made of a material such as natural fiber, synthetic fiber, synthetic resin, metal fiber, etc., and is composed of a porous sheet such as a nonwoven fabric, a sintered body, a microporous body, a knitted fabric, etc. Is a porous filter which is impregnated with a necessary detection reagent or has a structure in which the detection reagent dried and solidified is laminated in two or three layers. The detection reagent here means a labeled antibody that detects an antigen by an antigen-antibody reaction.

The label used for the labeled antibody in the present invention is at least one selected from enzymes, metal colloids and latex, and is used to directly and visually measure the result of the antigen-antibody reaction. . They are,
Under certain conditions, it binds to the protein by heteropolar binding or electrostatic adsorption, but this does not cause denaturation of the protein,
In addition, it has the characteristic that no decrease in physiological activity is observed.

The judgment sheet in the present invention is made of a hydrophilic material such as cellulose or cellulose acetate. An antibody that reacts with a labeled antibody (hereinafter referred to as a reaction reagent) is impregnated in advance on the determination sheet fixed by the determination plate, and reacts with the components in the sample and the detection reagent that have passed through the filtration unit. The judgment sheet is impregnated with, for example, an anti-hCG mouse monoclonal antibody specific to hCG or the like to directly make a pregnancy diagnosis.

The judgment plate is made of synthetic resin such as polyvinyl chloride, polyethylene, polypropylene, polyester, polyamide, polycarbonate, acrylic resin,
The end face has a holding means so that the determination sheet is fixed at a position directly below the filtering portion.

The water absorbent in the present invention is preferably absorbent cotton, non-woven fabric of hydrophilic fiber or the like, which is highly absorbent and elastic, and can be used as a laminated product such as laminated absorbent cotton.

The indicator in the present invention is a non-woven fabric using a cellulose derivative, glass, ceramics, etc.
Cloth, paper, filters, etc. are used.

Further, in the present invention, as a color source for coloring the indicator for confirming the completion of the reaction, a color former that develops or discolors when it is wet with water in urine or serum is used, or a water-based agent that bleeds with water is used. Use ink. As the color-developing agent, the pH of blood is usually 7.2 to 7.4, p of urine is
Since H is 4.6 to 8.0, pH 4.6 to 8.
It is preferable that the color always develops at 0. For example, ethanol solutions such as bromocresol green, 2.5 dinitrophenol and bromophenol blue, saturated isopropanol solutions of cobalt chloride, and chloride-based hygroscopic agents such as calcium chloride and methanol, which is a basic dye such as crystal violet or brilliant green. For example, a solution is used, and the solution is impregnated in a position visible from the judgment window. As the water-based ink, a color ink that belongs to the writing ink among the color inks and is easily scattered in water is used, and is attached to the side closer to the filtering portion than the judgment window. For example, red ink (eosin), blue ink (methylene blue), purple ink (methyl violet), green ink (malachite green), yellow ink (tartrazine), etc. are colored by adding an organic dye to prevent precipitation. It can be made by mixing a little. Others In the present invention, water-based inks for felt-tip pens are used, but blue black ink, black ink, India ink, etc. are not used. The color of the water-based ink is not particularly limited, but it is preferable to select a color that can be reliably distinguished from the labeled antibody on the reaction layer.

In the present invention, the sample collecting portion for collecting urine may be a sponge material such as cellulose, urethane foam, or polyvinyl alcohol, which has a water-retaining property, or a laminated product in which absorbent cotton, non-woven fabric, cloth or the like is used alone or in combination. Can be used.

As the material of the tip portion which covers the sample collecting portion, rubber or elastomer which is easily deformed by an external force is used. For example, butadiene rubber, isoprene rubber, chloroprene rubber, acrylic rubber, urethane rubber,
Examples thereof include silicone rubber, fluororubber, polysulfide rubber, polyether rubber, and chlorosulfonated polyethylene.

[0020]

According to the present invention, the detection reagent contained in the filtering section is dissolved by adsorbing the sample collected by the stick that is separable from the inspection tool main body into the judgment sheet on the plate. The reaction reagent impregnated in the determination sheet immediately reacts with the components in the sample and the detection reagent. Further, since the sheet portion that is colored after a certain time is provided, the end of the reaction can be surely determined, and the determination is not confusing by changing the color and the color system of the determination portion. Moreover, since the determination is performed by pulling out the plate from the main body of the inspection tool, the determination sheet is separated from the moisture absorber, and the reaction result can be maintained in a stable state without discoloration due to the backflow of the liquid from the moisture absorber.

The diagnostic container of the present invention is preferable for a urine test, but may be used for diagnosing a liquid sample other than urine such as blood.

[0022]

EXAMPLE An example of the diagnostic container according to the present invention will be described with reference to FIGS. FIG. 1 is a plan view of the diagnostic container of the present invention. That is, it is a diagnostic container including an openable / closable inspection tool body 1 in which an upper box 2 and a lower box 5 are integrally molded of synthetic resin. The upper box 2 is provided with a projection 3 for pressing the tip 11 of the stick 10 and a finish confirmation window 4a through which discoloration of the indicator can be seen. The upper box 2 has a locked portion 17 and the lower box 5 has a locking portion 18 so that the upper and lower boxes can be attached and detached.

FIG. 2 is a rear view of the stick of the diagnostic container according to the present invention and a view taken along the line YY in the same figure. That is, the stick 10 is composed of the tip portion 11, and the sample collecting portion 12 is attached inside the tip portion 11.

FIG. 3 is a view on arrow XX in FIG.
That is, the moisture absorber 13 is laid on the lower box body 5, and the determination plate 9 provided with the determination sheet 14 is inserted on the upper surface thereof. Then, an inner case 6 is fitted so as to cover the lower box body 5, and the inner case has a filtering portion 8 facing the determination sheet 14 and fixed by a fixing member 7. Further, the inner case 6 is provided with a recess so that the stick 10 can be easily set in the container, and the tip portion 11 is placed on the upper surface of the filtering portion 8.

FIG. 4 is a plan view when the inner case 6 of the diagnostic container according to the present invention is removed. That is, the inside of the lower box 5 is partitioned by the separating plate, the separating plate 16a serves as a moisture absorber housing portion, and the separating plate 16b serves as an indicator supporting portion.

FIG. 5 is a plan view of the inner case 6 of the diagnostic container according to the present invention. That is, the inner case 6 is provided with the end confirmation window 4b at a position where the discoloration of the indicator 15 can be seen. Further, the shape of the stick 10 is provided with a depression, and the tip end thereof has the filtering portion 8 fixed by the fixing member 7.

FIG. 6 is an enlarged perspective view of the plate of the diagnostic container of the present invention, and the moisture absorber 13 and the indicator 1.
5 is an enlarged perspective view of FIG. That is, the plate portion comprises the judgment plate 9 having a holding means and the judgment sheet 14 impregnated with the reaction reagent. In addition, the moisture absorber 13 is the separation plate 1
6a is housed inside, and the indicator 15 is the separation plate 1
6b is used as a support base so that one end is placed on the moisture absorber 13 and the other end is placed on the lower surface of the end confirmation window 4a.

FIG. 7 is an enlarged perspective view of the fixing member 7 and the filtering portion 8 of the diagnostic container according to the present invention. That is,
Filtering unit 8 impregnated with labeled antibody in antigen-antibody reaction
Are inserted in the fixing member 7, and these are fitted in the inner case 6.

When the diagnostic container of the present invention is used, urine is applied to the stick 10 and then the specimen collecting part 12 of the stick 10 is set in the inspection tool main body 1 facing downward to face the filtering part 8. Then, when the lid is closed, the convex portion 3 of the upper box body 2 presses the tip portion 11 of the stick 10, and the sample collecting portion 1
Urine is squeezed out from 2. The urine dissolves the detection reagent while passing through the filtration unit 8 and reacts with the reagent of the determination sheet 14. After a lapse of a certain period of time, the judgment plate 9 is pulled out from the container, and the pregnancy can be judged by the change in the color of the judgment sheet 14.

During pregnancy, since hCG (human ciliated gonadotropin) is excreted in urine, hCG is captured by the mouse monoclonal antibody impregnated in the judgment sheet 14 due to the antigen-antibody reaction. The captured hCG is detected by, for example, an antibody labeled with gold colloid in the detection reagent, and the determination sheet 14 is immediately colored reddish purple by the gold colloid particles. In the case of negative, hCG is not detected, so no coloring is seen.

End confirmation window 4a of the upper box 2 of the diagnostic container
Also, the star-shaped end confirmation window 4b of the inner case 6 informs that the reaction of the reagent has ended, and the user can know that the judgment possible time has come with the lid of the article closed. .

Next, based on the above-mentioned embodiment, a positive judgment was tried. A saturated isopropanol solution of cobalt chloride was applied on the judgment sheet 9 and dried, and then set between the filtration unit 8 and the judgment plate 9 to prepare a container for inspection. Then, the test sample solution containing hCG was sufficiently applied to the sample collecting section 12 of the stick 10, and it was set in the diagnostic container and the lid was covered. After 1 minute 20 seconds, the indicator 15 visible from the completion confirmation window 4a was colored pink. Since it could be expected that the reaction was completed, the judgment plate 9 was pulled out. The judgment sheet 14 at the center of the judgment plate 9 had reddish purple spots, and it was confirmed to be positive.

Similarly, based on the above example, an attempt was made to determine negative. A saturated isopropanol solution of cobalt chloride was applied on the judgment sheet 9 and dried, and then set between the filtration unit 8 and the judgment plate 9 to prepare a container for inspection. Then, the test sample solution not containing hCG was applied to the sample collecting section 12 of the stick 10, set in the diagnostic container, and the lid was closed. After 1 minute 20 seconds, the indicator 15 visible from the end confirmation window 4a was colored pink. Since it could be expected that the reaction was completed, the judgment plate 9 was pulled out. No spot was found on the judgment sheet 14 in the center of the judgment plate 9, and it could be confirmed that the spot was negative.

[0034]

By incorporating all the reagents necessary for the reaction into the diagnostic container as in the present invention, the stack 10 can be obtained.
It became possible to make an accurate judgment immediately by simply setting in the diagnostic container. And by using the switch 10 that can be separated from the diagnostic container and has a wide sampling area,
Moreover, it has become possible to collect samples hygienically. Further, the change of the color of the indicator 15 seen from the end confirmation window 4a makes it possible to easily judge the end of the reaction after a lapse of a certain period of time, and by changing the color system of the judging section, the judgment is not confusing. Furthermore, since the judgment sheet 14 is separated from the moisture absorber 13 for judgment, the vicinity of the judgment plate is isolated from moisture, and it is possible to maintain a clear color even after the reaction is completed.

[Brief description of drawings]

FIG. 1 is a plan view of a diagnostic container according to the present invention.

FIG. 2 is a rear view showing a stack of the diagnostic container of the present invention and a view taken along the line YY in the same figure.

FIG. 3 is a view on arrow XX in FIG.

FIG. 4 is a plan view when the inner case of FIG. 1 is removed.

FIG. 5 is a plan view of an inner case of the diagnostic container of the present invention.

FIG. 6 is an enlarged perspective view of a determination plate of the diagnostic container of the present invention and an enlarged perspective view of a moisture absorber and an indicator.

FIG. 7 is an enlarged perspective view of a fixing member of the diagnostic container of the present invention and an enlarged perspective view of a filtering unit.

[Explanation of symbols]

 1 Inspection tool main body 2 Upper box body 3 Convex part 4a End confirmation window 4b End confirmation window 5 Lower box body 6 Inner case 7 Fixing member 8 Filtration part 9 Judgment plate 10 Stick 11 Tip part 12 Sample collection part 13 Moisture absorber 14 Judgment Seat 15 Indicator 16a Separation plate 16b Separation plate 17 Locked part 18 Locking part

Claims (6)

[Claims] 1. A stick capable of impregnating a specimen at its tip,
It is composed of an inspection tool main body for accommodating this stack, and the inspection tool main body is composed of an upper box and a lower box, the upper box has a convex portion for pressing the tip of the stack, and the lower box has a stack. The inner case for mounting is attached,
In the inner case, a filter section containing a labeled antibody for detecting an antigen by an antigen-antibody reaction is fixed at a position where the tip of the stick is pressed by the convex section, and a reaction with the antigen is made under the filter section. A diagnostic plate having a sheet portion containing an antibody is arranged so that it can be inserted into and removed from the main body of the inspection tool, and a moisture absorber is laid between the determination plate and the bottom of the lower box body. container. 2. An indicator for indicating the arrival of the inspection result is fixed between the judgment plate and the absorber,
2. The diagnostic container according to claim 1, wherein a confirmation window is provided on the inner case to see the tip of the indicator. 3. The diagnostic container according to claim 2, wherein the upper box is provided with a confirmation window at a position facing the confirmation window of the inner case. 4. The diagnostic container according to claim 1, wherein the upper box and the lower box are integrally molded via a thin portion. 5. The diagnostic container according to claim 1, wherein the upper box has a locking portion, and the lower box has a locked portion. 6. The diagnostic container according to claim 1, wherein the upper box has a locked portion and the lower box has a locking portion.