JPH08193996A - Device for judging excretion occult blood - Google Patents

Abstract

PURPOSE: To obtain a device for judging the excretion occult blood using an immune filter method which has comparatively simplified configuration and by which the entire process for excretion occult blood judging operation can be simplified. CONSTITUTION: This device is provided with an excretion sampling tool 2 and buffer container 3. The excretion sampled by an excretion holding part 5a is dissolved by a buffer 14 to make a dissolved liquid of excretion sample, and a liquid-tight sealing material 12 is penetrated by a projecting part 13 to introduce the dissolved liquid to a filter mounting part 10, then an insoluble solid substance is removed by a separating filter 15 in the part 10. As a result, it can be judged whether an immune filter 16 contains excretion occult blood according to the immune filter method.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a simple test device for determining the presence or absence of fecal occult blood, and more particularly to a device for determining fecal occult blood using an immunological method.

[0002]

2. Description of the Related Art Fecal occult blood is produced by digestive system diseases resulting from contamination of blood in the stool in the digestive tract. Particularly, the correlation with diseases such as colorectal cancer has been confirmed, and it is a very important and widely used test as an index for early diagnosis of colorectal cancer, which is increasing in number in Japan.

Currently used fecal occult blood test methods include:
There are two main methods. The first method is called a conventional chemical occult blood reaction (hereinafter referred to as “chemical method”), which is a nonspecific reaction for detecting peroxidase-like activity of hemoglobin (hereinafter referred to as Hb). Is. This method is based on a mechanism in which a chromogen (such as guaiac butter or orthotolidine) is oxidized in the presence of a peroxidase-like activity-retaining substance and hydrogen peroxide solution to develop a color. Therefore, in this method, since the drug is a peroxidase-like activity-retaining substance, food containing Hb, and the like are positive, medication and dietary restriction were required.

A simple measuring system is disclosed as an inspection device based on the present chemical method, and some of them are widely used. For example, Japanese Examined Patent Publication No. 2-45826 and Japanese Patent Laid-Open No. Sho 5
In JP-A-9-168370, JP-A-62-266463, and JP-A-62-153573, a small amount of a stool sample is applied to a card containing a test paper impregnated with guaiac fat or the like, and then peroxidized. A system is disclosed in which hydrogen water is dropped to check the color appearance. In these systems,
Whether a suitable amount of stool sample is applied on a part of the guaiac fat attached to the card type body and hydrogen peroxide solution is dripped on the part on the back side of the application part to see if the guaiac fat in the dripping part develops color. Determine with. It is advantageous that it can be performed without opening the stool sample application part, that it can be handled hygienically, and that it has a simple structure, but the drawbacks derived from the above-mentioned measurement principle have not been solved.

The second method has been recently developed to solve the above-mentioned drawbacks of the chemical method, and is a method based on an immune reaction (hereinafter referred to as "immunization method"). Since this method is a method based on an antigen-antibody reaction using an anti-human Hb antibody, it has high specificity and does not require dietary restrictions such as chemical methods. The determination is performed by a general immunoserologic test method such as a latex agglutination method or an enzyme-labeled immunoassay, but the most widely used method at present is the latex agglutination method.

In the latex agglutination method, a stool sample solution and a latex reagent are dropped on a judgment plate and mixed, and judgment is made based on the presence or absence of an agglutination image. In principle, the specificity is higher than that of the chemical method, but skill in determining the agglutination method is required. Further, the test system based on the immunoassay is provided as a kit including a judgment plate, a latex reagent, a stirring rod, a stool collection instrument, a solution, etc., but has a complicated structure and is as simple as the above chemical method. The system has not been developed.

[0007] The simplification of these immunization methods is to carry out a step unique to the immunization method, which is not present in the chemical method, that is, a step of dissolving a stool sample in a buffer solution or the like, and a non-dissolved solid content in the dissolved solution after being removed by filtration. It is done about the process of doing. That is, for these operations, a stool collection device capable of relatively quantitative and hygienic handling is disclosed, for example, Japanese Utility Model Publication No. 3-44363 and Japanese Utility Model Publication No. 2-13977.
Japanese Utility Model Publication No. 1-66071 Japanese Utility Model Publication No. 1-85
In Japanese Patent No. 668 and Japanese Utility Model Application Laid-Open No. 64-42454, a collection rod for collecting feces is attached to the lid of a container containing a buffer solution, and the lid is set in the buffer container after the collection of feces. Thereby, the stool at the tip of the collecting rod is dispersed in the buffer solution. In addition, a filter mechanism is installed in the dropping portion to remove insoluble solids when the droplet is dropped onto the determination plate from the dropping portion after being shaken well. After dropping onto the judgment plate, the operation is carried out according to the usual method of the above-mentioned latex agglutination method.

The simplification of the fecal occult blood measurement system by the immunization method is considered to be achieved by the integration of the above steps and the antigen-antibody reaction, but the technique has not been realized so far.

[0009]

In recent years, with the spread of the concept of self-care, a simple test system based on an immune reaction has become available as a general test drug at pharmacies and the like. For example, for pregnancy diagnostics, a simple test system using an immunochromatography method has been established. The biggest problem in using the immunochromatography method for fecal occult blood test is that the stool sample lysis and filtration steps are difficult to be incorporated into the system.

An object of the present invention is a fecal occult blood test apparatus using an immunological method, which has a relatively simple structure.
It is an object of the present invention to provide a fecal occult blood determination device that can simplify and accurately determine the presence or absence of fecal occult blood even for an unskilled person, because the operation is simplified over all steps of the fecal occult blood determination operation.

[0011]

The inventions set forth in claims 1 to 6 have been made to achieve the above object,
A fecal occult blood determination device comprising a stool collection device having a stool holding part for holding the collected stool on the outer surface, and a buffer container into which the stool collection device is inserted from above, respectively,
It is characterized by having the following configuration.

In the invention according to claims 1 and 2, the stool collection device has a first communication hole for communicating the outside air with the inside of the buffer solution container when inserted into the buffer solution container, and the first communication hole downwardly. An open filter installation portion and a second communication hole that communicates the filter installation portion with the outside air are formed.

Further, a liquid-tight sealing material is attached so as to close the opening below the filter installation portion.
The liquid-tight seal material is provided to prevent the buffer solution in which the stool sample is dissolved from flowing into the filter installation portion.

In the filter installation section, a separation filter is arranged above the liquid-tight seal material. The separation filter is provided for filtering the buffer solution in which the stool sample is dissolved.

Further, in the invention described in claim 1, in the filter installation portion, the immunofilter is arranged above the separation filter, and the immunofilter is such that the anti-hemoglobin antibody-sensitized carrier can be moved by the buffer solution. And has a pore through which an anti-hemoglobin antibody-sensitized carrier can pass but a product resulting from an antigen-antibody reaction between the anti-hemoglobin antibody-sensitized carrier and hemoglobin cannot pass.

Further, in the invention according to claim 2, an anti-hemoglobin antibody sensitized carrier is movably installed by a buffer solution in the filter installation part, and the anti-hemoglobin antibody is further installed in the filter installation part. A second anti-hemoglobin antibody having a different recognition site is immovably immobilized, and an immunofilter is provided so as to have pores through which the anti-hemoglobin antibody-sensitized carrier can pass.

Further, in the invention described in claims 1 and 2, when the stool collection tool is inserted into the buffer solution container, the projection for breaking the liquid-tight sealing material by moving the stool collection tool is moved. Parts are formed.

The third aspect of the present invention has a structure similar to that of the fecal occult blood determination apparatus of the first and second aspects of the invention, but uses an immunochromatographic method instead of an immunofilter method. It is a fecal occult blood determination device.

That is, in the invention described in claim 3, in the feces collecting instrument, a communication hole for communicating the outside air with the inside of the buffer solution container when inserted into the buffer solution container, and a development layer opened downward are installed. And a part are formed.

A liquid-tight seal material is attached so as to close the opening below the spread layer installation portion. The liquid-tight seal material is provided to prevent the buffer solution in which the stool sample is dissolved from flowing into the development layer installation portion.

A separation filter is arranged above the liquid-sealing component in the spreading layer installation section. The separation filter is provided for filtering the buffer solution in which the stool sample is dissolved.

Further, in the development layer installation section, a development layer is arranged, and an anti-hemoglobin antibody sensitized carrier is installed in the development layer, and the anti-hemoglobin antibody is immobilized. Also, in the development layer installation section,
In order to allow the development layer to be observed from the outside, the fecal sampling device is formed with a judgment window and an end window.

Also in the invention described in claim 3, in the buffer solution container, when the stool collection tool is inserted, a protrusion for breaking the liquid-tight sealing material by moving the stool collection tool is formed. ing.

In the inventions according to claims 4 and 5, the feces collecting device is provided with a filter setting portion for judging fecal occult blood according to the immunofilter method. This filter installation part has an opening for introducing the buffer solution in which the stool sample is dissolved into the filter installation part. A liquid-tight sealing material is attached to the stool collection device so as to close the opening of the filter installation portion.

In addition, a communication hole is formed in the above-mentioned fecal sampling device so that the filter installation portion and the outside air can communicate with each other. A separation filter is arranged above the liquid-tight sealing material in the filter installation portion. The separation filter is
A stool sample is provided to remove insoluble solids in the dissolved buffer.

Furthermore, in the filter installation section, an immune filter is arranged above the separation filter. In the invention according to claim 4, the immune filter comprises:
The anti-hemoglobin antibody-sensitized carrier is movably installed by a buffer solution, and the anti-hemoglobin antibody-sensitized carrier can pass through, but the product of the antigen-antibody reaction between the anti-hemoglobin antibody-sensitized carrier and hemoglobin does not pass through. It is configured to have pores.

In the invention according to claim 5, the anti-hemoglobin antibody-sensitized carrier is movably installed in the filter installation part by a buffer solution, and further, in the filter installation part,
A second anti-hemoglobin antibody having a recognition site different from that of the anti-hemoglobin antibody is immobilized immovably, and an immunofilter having pores through which the anti-hemoglobin antibody-sensitized carrier can pass is constructed.

Further, in the fecal occult blood determining apparatus according to the fourth and fifth aspects of the present invention, the tip is directed toward the liquid-tight sealing material in order to break the liquid-tight sealing material by an external operation. A sealing material penetrating member is attached to the buffer solution container so that it is extended and the tip is extended to the liquid-tight sealing material side.

[0029] In the invention according to claim 6, in the stool collection device, a communication hole for communicating the outside air with the inside of the buffer solution container when inserted into the buffer solution container, and a development layer opened downward And a part are formed. A development layer is arranged in the development layer installation portion, and an anti-hemoglobin antibody-sensitized carrier is installed in the development layer and an anti-hemoglobin antibody is immobilized. Further, in the development layer installation section, a separation filter is arranged below the development layer. This separation filter is provided to filter the buffer solution in which the stool sample is dissolved. Further, a liquid-tight seal material is arranged below the separation filter. The liquid-tight seal material is provided to prevent the buffer solution, in which the stool sample is dissolved, from entering the development layer installation portion.

Further, in the above-mentioned development layer installation section, a judgment window and an end window are formed in the stool collection device so that the development layer can be observed from the outside. Further, also in the invention according to claim 6, in order to break the liquid-tight seal material by an operation from the outside, the tip is extended in the liquid-tight seal material direction, and the tip is extended. A sealing material penetrating member is attached to the buffer solution container so that the liquid is fed to the liquid-tight sealing material side.

In determining fecal occult blood using the fecal occult blood determining apparatus according to the first to sixth aspects of the present invention, a stool sample is collected in the stool holding portion of the stool collecting device, and the stool collecting device is placed from above. Insert into buffer container. As a result, the stool sample is dissolved in the buffer solution in the buffer solution container, and a buffer solution in which the stool sample is dissolved is prepared. In the invention described in claims 1 to 6, a liquid-tight sealing material is provided to prevent the buffer solution in which the stool sample is dissolved from entering the filter installation portion or the development layer installation portion.
Therefore, as it is, the buffer solution in which the stool sample is dissolved does not enter the filter installation part or the development layer installation part.

In the invention described in claims 1 to 3, the liquid-tight sealing material is pierced by the protrusion formed on the buffer solution container by moving the stool collection device. As a result, the buffer solution in which the stool sample is dissolved flows into the filter installation section. The lysate in which the stool sample is dissolved is filtered by a separation filter to remove the solid content. Next, the buffer solution in which the stool sample is dissolved and the solid content is removed is supplied to the immune filter or the spreading layer. Next, in the invention described in claims 1 and 2, the presence or absence of fecal occult blood is determined by the immune filter according to the immune filter method. Further, in the invention described in claim 3, the presence or absence of fecal occult blood is determined in the spreading layer according to the immunochromatographic method.

On the other hand, in the invention described in claims 4 to 6, by operating the sealing material penetrating member from the outside, the tip of the sealing material penetrating member is extended to the liquid tight sealing material side, whereby the liquid tight sealing material is provided. Break. As a result, the buffer solution in which the stool sample is dissolved flows into the filter installation part or the development layer installation part. The buffer solution in which the stool sample has been dissolved is filtered by a separation filter to remove the solid content. The buffer solution in which the stool sample is dissolved and the solid content is removed,
It is supplied to the spreading layer or the immune filter. Next, in the inventions of claims 4 and 5, the presence or absence of fecal occult blood is determined by the immune filter according to the immune filter method.
In the invention described in (1), the presence or absence of fecal occult blood is determined in the spreading layer according to an immunochromatographic method.

According to the third and sixth aspects of the present invention, the feces collecting device is formed with the judgment window and the end window for confirming the judgment and the end of the judgment in the spreading layer, so that it can be easily performed from the outside. The judgment can be made and the end of the judgment can be confirmed.

[0035]

Embodiments of the present invention will now be described with reference to the drawings. First Embodiment FIG. 1 is a vertical sectional view showing a fecal occult blood determining apparatus according to an embodiment of the present invention. The fecal occult blood determination device 1 of the present embodiment includes a fecal sampling device 2 and a buffer solution container 3.

The stool collection device 2 is made of synthetic resin and has a lid 4 and a substantially columnar stool collection device body 5 having a smaller diameter than the lid 4. A concave portion 4a that opens upward is formed inside the lid body 4, and the concave portion 4a communicates with the outside air through a through hole 4b formed in a side wall of the lid body 4. A plug 6 is attached to the through hole 4b so as to close the through hole.

A feces holding portion 5a is formed at the tip of the body 5 for collecting feces. The stool holding portion 5a is formed by giving unevenness to the outer peripheral surface, and is provided for semi-quantitatively collecting stool. The shape of the stool holding portion 5a is not limited to the shape having the unevenness as shown in the figure, and may have various shapes such as depressions and protrusions as long as semi-quantitative stool can be collected. Moreover, the number of such depressions and protrusions is not particularly limited.

On the other hand, the stool collection instrument body 5 is formed with a first communication hole 7 extending in the lengthwise direction. First communication hole 7
Is formed to communicate the inside of the buffer solution container 3 with the outside air in a state where the stool collection device 2 is inserted into the buffer solution container 3. A plug 8 is attached to the upper end of the first communication hole 7.

A second communication hole 9 is formed in the stool collection device body 5. The lower end of the second communication hole 9 is open to the filter installation portion 10 described later. The upper end of the second communication hole 9 is configured to reach the recess 4a of the lid 4.
A plug 11 is attached to the upper end of the second communication hole 9.

A lid 4c is detachably attached above the recess 4a. In addition, the stool collection device body 5
A filter installation portion 10 that opens downward is formed inside. As shown in the figure, the filter installation unit 10 is configured as a space that extends in the length direction of the stool collection instrument body 5 and opens downward.

The lower opening of the filter installation portion 10 is closed by a liquid-tight seal material 12. Liquid-tight sealing material 12
Is required to have a strength such that it is hard to be broken in order to collect a stool sample, but is configured to have a material and strength that can be easily pierced by the protrusion 13 provided on the inner surface of the bottom of the buffer solution container 3. Has been done. The liquid-tight sealing material 12 may be a synthetic resin film such as a polyethylene film or a polypropylene film, a metal foil such as an aluminum foil, or a suitable adhesive or adhesive such as a hot-melt adhesive on one surface of a laminate of these. Can be configured by

The liquid-tight sealing material 12 has a function of preventing the inflow of feces into the body 5 of the stool collection device and a flow of the buffer solution 14 in the buffer container at the time of stool collection. A separation filter 15 is arranged above the liquid-tight seal material 12. The separation filter 15 is provided to remove insoluble solids in the fecal sample solution. Therefore, the separation filter 15 is attached such that the outer peripheral surface thereof is in close contact with the inner peripheral surface of the filter installation portion 10. Since the separation filter 15 has the above-described filtration function, it can be made of a known filter paper, a separation membrane such as nitrocellulose, or a filter material. The separation filter 15 may be made of a cellulose-based or synthetic polymer-based porous material.

An immune filter 16 is arranged above the separation filter 15. The immune filter 16 is provided to carry out a known immune filter method and utilizes a latex agglutination reaction. In the latex agglutination reaction method, for example, an immunoreaction product resulting from an antigen-antibody reaction between an antibody-sensitized latex and an antigen forms a three-dimensional network structure to generate an aggregate.

By carrying out the above-mentioned immunoreaction on a filter having a large number of pores through which the above-mentioned aggregates cannot pass but non-aggregates can pass, the presence or absence of latex on the filter after the reaction, or on the filter Positive or negative is judged depending on the presence or absence of colored latex accumulated in the space.

At the time of the determination, preferably, the color tone of the carrier has a clear contrast with the immune filter or the space below the filter, whereby the determination can be made more reliable and easy.

In the present invention, the above-mentioned antigen is human hemoglobin in the stool lysate, and the antibody is anti-human hemoglobin antibody. The anti-human hemoglobin antibody is immobilized on the latex particles, but is immobilized by the buffer solution so that it can be dissolved.

As described above, in the immune filter 16, the product of the antigen-antibody reaction, that is, the aggregate does not pass through the immune filter 16, but the antibody-sensitized carrier originally installed is dispersed by the stool sample solution. After being processed, it passes through the immune filter 16. As described above, if the color tone of the carrier and the color tone of the immune filter 16 or the space on the immune filter 16 have a clear contrast, positive and negative determinations can be made easily and reliably.

In order to make the color tone of the carrier different from the color tone of the portion where the carrier is present and the color of the agglomerate, it is preferable to use a colored carrier. For example, it is preferable to use a white carrier when the background is black and a colored carrier when the background is white. Most preferred as the carrier is latex particles, but since latex particles are usually white, when the background is white, for example, styrene, latex particles obtained by emulsion polymerization of vinyltoluene, etc. And in a reaction medium containing an organic solvent compatible with water, a method of coloring by contacting with a poorly water-soluble colorant dissolved in the reaction medium, or obtained by emulsion polymerization and having an anionic functional group In an aqueous reaction medium, latex particles, for example, latex particles composed of a copolymer containing a monomer having an anionic functional group such as (meth) acrylic acid, are dissolved in the reaction medium, and the coloring agent is an amphoteric electrolyte. It is preferable to use latex particles obtained by a method of contacting with and coloring.

The anti-human hemoglobin antibody used in this example can be obtained by purifying the antiserum obtained by immunizing rabbits, sheep, goats, horses, guinea pigs, etc. with human hemoglobin by affinity chromatography or the like. . It is also possible to produce a monoclonal antibody by a known cell fusion method using immunized mouse spleen cells. In any case, it is desirable that the anti-human hemoglobin antibody used be sufficiently purified.

The buffer solution 14 contained in the buffer solution container 3 is preferably a neutral salt solution such as ammonia buffer solution, glycine buffer solution, phosphate buffer solution or Tris buffer solution, and particularly preferred. Include the above buffer solutions having a pH range of 6.5 to 8.5. The amount of the buffer solution is preferably about 0.5 to 10 ml, though it depends on the amount of the stool sample to be collected.

Returning to FIG. 1, the first communication hole 7 is provided for communicating the inside of the buffer solution container 3 with the outside air when the feces collecting device 2 is inserted into the buffer solution container 3. The communication hole 7 is provided as an air vent hole to facilitate the work of inserting the stool collection device 2 into the buffer solution container 3 and the work of pulling up the stool collection device 2 to start the reaction. . Therefore, in use, the above-mentioned stopper 8
Are removed.

In the present embodiment, the lid 4 and the stool collection device main body 5 which compose the stool collection device 2 are integrally made of synthetic resin. However, the lid body 4 and the stool collection device body 5
It may be configured separately from and may be joined with an adhesive or the like. Further, the stool collection device 2 can be made of other appropriate material such as metal.

The shape of the projection 13 is not limited to the illustrated shape as long as the liquid-tight sealing material 12 can be pierced, and the projection 13 can be formed in an appropriate shape and a plurality of projections may be provided. .

Although the internal volume of the buffer solution container 3 is not particularly limited, it is usually about 1 to 10 ml in constructing the fecal occult blood determination apparatus 1. Further, the buffer container 3 is
It may be made of an appropriate synthetic resin such as polyethylene, polypropylene, or vinyl chloride resin, but may be made of another material such as glass or metal.

Next, a method of using the fecal occult blood determining apparatus shown in FIG. 1 will be described with reference to FIGS. 2 and 3. First, FIG.
The stopper 8 of the fecal occult blood determination device 1 assembled as shown in (1) is removed, and then the fecal sampling device 2 is pulled out from the buffer solution container 3.

In the initial assembled state shown in FIG. 1, the liquid-tight seal material 12 is arranged at a position separated from the tip of the protrusion 13 by a predetermined distance. A stopper may be provided on the side of the stool collection device 2 or the buffer solution container 3 so that the liquid-tight seal material 12 is not pierced by the protrusion 13 before use. That is, a stopper that regulates the insertion depth of the stool collection device 2 is provided so that the liquid-tight seal material 12 provided on the stool collection device 2 side does not contact the tip of the protrusion 13.
It may be provided on the outer surface and / or the upper end of the buffer solution container 3. However, when the determination operation described later is started, the liquid-tight sealing material 12 needs to be pierced by the protruding portion 13, and therefore the stopper is detachable or the stopper of the stool collection tool 2 is manually inserted. It must be configured so that the function can be released.

Next, as shown in FIG. 2A, the stool collection device body 5 of the stool collection device 2 is pierced into the feces A to collect stool.
In some cases, after the stool has been pierced and the stool collection device body 5 has been removed from the stool, excess stool attached to the stool holding portion 5a may be wiped off and removed. Next, the stool collection device 2 is reinserted into the buffer solution container 3 (see FIG. 2B).

In this state, the buffer solution container 3 is swirled, and the fecal occult blood determination apparatus 1 is turned over in some cases, whereby the stool sample is dissolved in the buffer solution 14. Next, FIG.
As shown in (c), the stool collection device 2 is moved downward, and the liquid-tight seal material 12 (see FIG. 1) is pierced by the protrusion 13.
After that, the lid 4c of the lid body 4 is opened, and the plug 1 in the recess 4a is opened.
Remove 1. Next, as shown in FIG. 3A, the stool collection device 2 is slightly pulled up. As a result, the stool sample solution flows into the filter installation unit 10. Next, the stopper 8 is attached.

Next, as shown in FIG. 3B, the fecal occult blood determining apparatus 1 is turned upside down. Further, the stopper 6 is removed. The stool sample solution is filtered by the separation filter 15 and dropped on the immune filter 16. In the immunofilter 16, when the reaction by the above-mentioned immunofilter method progresses and human hemoglobin is present in the stool sample solution, an antigen-antibody reaction occurs on the immunofilter 16 and the antibody-sensitized carrier and human hemoglobin The reaction of (1) produces an immune reaction product (aggregate). Therefore, the antibody-sensitized carrier is dispersed in the buffer solution, but since an aggregate is formed by the antigen-antibody reaction, the space D to be located below the immune filter 16 (see FIG. 3B). ) Does not flow out. Therefore, the color tone of the antibody-sensitized carrier is not observed in the space D (positive).

On the other hand, when human hemoglobin is not present in the stool sample solution, the antibody-sensitized carrier does not cause the above antigen-antibody reaction. Therefore, the buffer solution in which the stool sample is dissolved passes through the immune filter 16 and reaches the space D. Therefore, the color tone of the antibody-sensitized carrier is observed (negative).

Then, after the judgment is completed, by attaching the stopper 6, it is possible to prevent the stool sample solution from leaking, and the measurement is completed. As described above, in the fecal occult blood determination apparatus 1 of the present embodiment, fecal occult blood is obtained by simply collecting a stool sample using the stool collection device body 2, inserting the stool sample into the buffer solution container 3, and performing the above-described simple steps. The presence or absence of can be reliably and easily performed.

Modified Example of First Embodiment FIG. 4 is a vertical sectional view for explaining a modified example of the fecal occult blood determining apparatus of the first embodiment. In the fecal occult blood determination device 21 of this modified example, the second communication hole 9 is opened in the bottom surface portion of the concave portion of the lid body 4. Here, the lid 4c is not attached to the lid body 4. The other points are similar to those of the first embodiment. In this embodiment, by connecting a vacuum suction source to the upper end of the second communication hole 9, the stool sample solution is sucked into the filter installation section 10 by vacuuming and is supplied to the immune filter 16. . Therefore, it is possible to more quickly determine the presence or absence of fecal occult blood.

FIG. 5 and FIG. 6 are cross-sectional views for explaining a modified example of the lid of the stool collection device used in the first embodiment. The lid 4 of the stool collection device 2 may be modified as shown in FIGS. 5 and 6.

For example, in the structure shown in FIG. 5, a hollow portion 4h is formed in the lid body 4. This hollow portion 4h is
It communicates with the filter installation unit 10. The elastic film 4i is attached so as to cover the space below the hollow portion 4h. A lid 4c is integrally formed above the lid body 4. With this structure, when the feces solution is introduced into the filter installation unit 10, the elasticity of the elastic film 4i can be used to introduce the feces solution into the filter installation unit 10.

Further, in the structure shown in FIG. 6, a hollow portion 4h is formed in the lid body 4, and a hollow elastic spherical body 4k is attached in the hollow portion 4h so as to communicate with the filter installation portion 10. . After squeezing the elastic sphere 4k, the stool sample solution can be sucked and introduced into the filter installation unit 10 by returning to the original shape.

As a material for forming the elastic film 4i and the elastic sphere 4k, an appropriate material such as synthetic rubber, natural rubber or synthetic resin having elasticity can be used.

The structures shown in FIGS. 5 and 6 can also be applied to the following second to sixth embodiments. Second Embodiment The second embodiment is an embodiment according to the invention described in claim 2, and is configured almost the same as the fecal occult blood determining apparatus 1 of the first embodiment. Therefore, the specific structure of the fecal occult blood determination apparatus of the second embodiment will be omitted by using the description of the first embodiment with reference to FIG.

The fecal occult blood determining apparatus of the second embodiment is different from the fecal occult blood range measuring apparatus of the first embodiment in that the immune filter is constructed according to the invention of claim 2.

That is, in the second embodiment, the anti-human hemoglobin antibody-sensitized carrier is movably installed in the filter installation part 10 by the buffer solution, and the recognition site is different from the anti-human hemoglobin antibody. The second anti-human hemoglobin antibody is immobilized immovably. This second
The anti-human hemoglobin antibody is immobilized on the immune filter 16. The anti-human hemoglobin antibody-sensitized carrier is arranged below the separation filter 15. Further, the immune filter 16 is configured to have pores through which the anti-human hemoglobin antibody-sensitized carrier can pass.

As described above, in the case of using the immunofilter in which the anti-human hemoglobin antibody-sensitized carrier is movably installed and the second antibody having a different epitope is immobilized so as to be immobilized, the above-mentioned first filter is used in the immunofilter. Since the anti-human hemoglobin antibody 2 is immobilized, the immune reaction product is trapped on the filter 16 (positive) by the sandwich method with hemoglobin in between. On the other hand, since the anti-human hemoglobin antibody-sensitized carrier can pass through the filter 16, in the case of a stool sample containing no hemoglobin, the color tone of the antibody-sensitized carrier can be observed in the determination space D (negative). Therefore, the presence or absence of fecal occult blood can be easily determined by the immune filter method as in the first embodiment.

Third Embodiment FIG. 7 is a vertical sectional view showing a fecal occult blood determining apparatus according to an embodiment of the present invention.

The fecal occult blood determination device 31 includes a fecal sampling device 32,
And a buffer solution container 33. The stool collection device 32 is made of synthetic resin and has a lid 32a and a substantially columnar stool collection device body 32b having a smaller diameter than the lid 32a. The stool holding portion 32c is formed on the main body 32b of the stool collecting tool by giving unevenness to the outer peripheral surface on the tip side thereof. The stool holding portion 32c is provided for semi-quantitatively collecting stool, but the shape of the stool holding portion 32c is not limited to the one having the unevenness shown in the figure, and the stool holding portion 32c is semi-quantitatively used. Can be configured to have various shapes such as depressions and protrusions, as long as they can be collected. Moreover, the number of such depressions and protrusions is not particularly limited.

Inside the stool collection instrument main body 32b, there is provided a development layer installation portion 32d which opens downward. Deployment layer installation section 3
In the present embodiment, 2d is formed as a hole that is opened in the side surface of the lower portion and extends in the vertical direction. Development layer installation unit 32
The lower part of d is closed by a liquid-tight seal material 34. The liquid-tight seal material 34 needs to have a strength that is not easily broken in order to collect a stool sample, but is configured to have a material and strength that can be easily pierced by a seal material penetrating member 41 described later. There is. The liquid-tight sealing material 34 is
It may be constituted by applying a synthetic resin film such as a polyethylene film or a polypropylene film, a metal foil such as an aluminum foil, or an appropriate adhesive or pressure-sensitive adhesive such as a hot-melt pressure-sensitive adhesive to one surface of a laminate thereof.

The liquid-tight seal member 34 has a function of preventing the inflow of feces into the body 32b of the stool collection device and a function of preventing the buffer solution 36 from entering the buffer container at the time of stool collection. The separation filter 37 is arranged in the development layer installation portion 32d. The separation filter 37 is provided to remove insoluble solids in the stool sample solution. Therefore, the separation filter 37 is attached on the lower end side of the development layer installation portion 32d such that the outer peripheral surface is in close contact with the inner peripheral surface of the development layer installation portion 32d. Separation filter 3
7 has a filtering function as described above,
It can be composed of a known filter paper, a separation membrane such as nitrocellulose, or a filter material. Further, the separation filter 37 may be made of a cellulose-based or synthetic polymer-based porous material.

Above the separation filter 37, a spreading layer 38 is formed.
Is arranged. The spreading layer 38 has its starting end 38a.
Are arranged above the separation filter 37. Therefore, the stool sample solution from which the solid content has been removed by the separation filter 37 penetrates into the starting end 38a.

On the other hand, in the stool collection instrument main body 32b, in order to allow the internal spreading layer 38 to be observed from the outside,
A judgment window 32e and an end window 32f are formed. FIG.
Then, only the positions where the judgment window 32e and the end window 32f are provided are schematically shown by circles. The determination window 32e is located above the start end 38a, and is provided for observing the determination result of fecal occult blood. Also, the end window 32f
Is disposed above the determination window 32e and is provided for visually observing the end of the immunochromatography.

It is preferable that the judgment window 32e and the end window 32f are liquid-tightly closed by a transparent material, so that liquid leakage can be prevented. As such a transparent material, a transparent synthetic polymer material such as polyethylene or polyvinyl chloride can be used.

The spreading layer 38 is provided to carry out a known immunochromatographic method, and is made of a porous material. That is, a carrier sensitized with an antibody against the test substance (hereinafter, abbreviated as the first antibody) is installed at the starting end 38a. In addition, a second antibody that recognizes an epitope different from that of the first antibody is immobilized at a position separated from the installation site of the first antibody-sensitized carrier by a certain distance.

When the test substance-containing liquid sample is spread from the starting end 38a of the spreading layer, the sample moves on the spreading layer 38,
In addition, the test substance causes an antigen-antibody reaction with the first antibody. The test substance-first antibody-sensitized carrier complex further moves in the spreading layer and reaches the second antibody immobilization site. As a result, the test substance was reacted with the second antibody by an antigen-antibody reaction to give the test substance-first
The antibody-sensitized carrier complex is trapped at the second antibody immobilization site. Therefore, if the carrier has a color tone having a clear contrast with the spreading layer 38, the presence of the carrier, that is, the presence of the test substance can be easily confirmed visually.

In this example, the test substance is human hemoglobin, which is an index for determining fecal occult blood, and the test substance-containing liquid sample is the above-mentioned fecal lysate. As the material for forming the spreading layer 38, for example, a cellulosic material such as nitrocellulose or cellulose acetate, a synthetic polymer material such as nylon, fluorinated ethylene resin, polypropylene, polyvinyl chloride resin, or the like has been used as a conventional membrane. Various materials used as the filter material can be used.

Further, the spreading layer 38 is required to have a function of exhibiting a clear contrast with the color tone of the carrier. Therefore, it is preferable to use a white carrier when the developing layer 16 is black and a colored carrier when the developing layer 38 is white. The most preferred carrier is latex particles, but since latex particles are usually white, when the background is white,
For example, styrene, latex particles obtained by emulsion polymerization of vinyltoluene, etc., in a reaction medium containing water and an organic solvent having compatibility with water, with a poorly water-soluble colorant dissolved in the reaction medium. Method of contacting and coloring, latex particles obtained by emulsion polymerization and having an anionic functional group, for example, (meth) latex particles made of a copolymer containing a monomer having an anionic functional group such as acrylic acid, It is preferable to use colored latex particles obtained by, for example, a method of contacting with a colorant which is an amphoteric electrolyte dissolved in the reaction medium to color it in an aqueous reaction medium.

The anti-human Hb antibody (first antibody) used in this example was obtained by immunizing rabbits, sheep, goats, horses, guinea pigs, etc. with human Hb and purifying the antisera by affinity chromatography or the like. It is obtained by doing. It is also possible to produce a monoclonal antibody by a known cell fusion method using immunized mouse spleen cells. In any case, it is desirable that the anti-human Hb antibody used be sufficiently purified.

The anti-human Hb antibody can be sensitized to the carrier by a known method such as a separation adsorption method or a chemical binding method. For example, a buffer solution of anti-human Hb antibody is added to latex, and the mixture is stirred at 37 ° C. for 30 to 120 minutes.
The antibody can be physically adsorbed on the latex surface by heating to. If a latex having a carboxyl group is used, the antibody can be bound to the latex by a covalent bond via a water-soluble carbodiimide or the like. If necessary, bovine serum albumin (hereinafter referred to as "B
SA ”. ) And the like may be added.

The first antibody-sensitized carrier thus obtained is placed on the spreading layer 38 by, for example, 0.01 to 10% by weight dispersion of the antibody-sensitized carrier in a predetermined amount of about 0.05 to 1 ml. It can be carried out by dropping it in a position and drying it at room temperature for 12 hours or more.

Further, on the spreading layer 38, the judgment window 32
The second antibody is immobilized on the site observed by e. As the second antibody, an anti-human hemoglobin antibody having a different epitope recognized by the first antibody can be used. The immobilization method is as follows: 1-5 mg / ml of the second antibody 0.1-1
An example is a method in which 0 μl is dropped at a predetermined position, left at room temperature for 12 hours or more, and then BSA or the like is dropped at the same position if necessary and dried.

The buffer solution 36 is preferably a neutral salt solution such as an ammonia buffer solution, a glycine buffer solution, a phosphate buffer solution and a Tris buffer solution, and particularly preferably a pH of 6.5 to 8. The buffer solution in the range of 5 is included. The amount of the buffer solution is preferably about 0.5 to 10 ml, though it depends on the amount of the stool sample to be collected.

Returning to FIG. 7, the stool collection tool 32 is formed with a communication hole 32g for connecting the inside of the buffer solution container 33 and the outside air when the stool collection device 32 is inserted into the buffer solution container 33. . The communication hole 32g is provided as an air vent hole to facilitate the work of inserting the stool collection device 32 into the buffer solution container 33 and the work of pulling up the stool collection device 32 to start the reaction.

Further, in the fecal occult blood determining apparatus 31 of this embodiment, the tight plug 39 for closing the communication hole 32g is fixed. The sealing plug 39 is provided to open and close the communication hole 32g, and can be made of, for example, a synthetic resin such as polyethylene or vinyl chloride resin and an elastic rubber such as natural rubber or synthetic rubber.

In the present embodiment, the lid 32a of the stool collection device 32 and the stool collection device main body 32b are integrally formed of a substantially rod-shaped synthetic resin. It may be configured separately from the portion 32b, and may be joined with an adhesive or the like. In addition, the stool collection device 32 is
It may be made of other appropriate material such as metal.

On the other hand, in the buffer solution container 33, the buffer solution 36 is stored in advance. An O-ring 40 is attached to the buffer solution container 33 in order to enhance the sealing property with the stool collection device 32 when the stool collection device 32 is inserted. Further, the buffer solution container 33 is provided with a seal material penetrating member 41 as a member for piercing the seal material 34 by operating from the outside. In this embodiment, the sealing material penetrating member 41 is used which has a needle-shaped portion 41a protruding inward and a planar operation portion 41b connected to the needle-shaped portion 41a. Such a sealing material penetrating member 41 is
It can be made of metal or a relatively hard synthetic resin. The outer surface of the operating portion 41 b of the seal member penetrating member 41 is covered with the elastic film 42. Elastic membrane 42
Is provided to surround the sealing material penetrating member 41 and prevent the buffer solution from leaking to the outside, and therefore the peripheral portion is fixed to the outer wall of the buffer solution container. The elastic film 42 can be made of, for example, synthetic rubber, natural rubber, or a synthetic resin film having elasticity.

Although the internal volume of the buffer solution container 33 is not particularly limited, it is usually about 1 to 10 ml in constructing the fecal occult blood determination device. In addition, the buffer container 33
Can be made of an appropriate synthetic resin such as polyethylene, polypropylene, or vinyl chloride resin, but may be made of other material such as metal.

Next, a method of using the fecal occult blood determining apparatus shown in FIG. 7 will be described with reference to FIGS. 8 and 9. First, FIG.
Fecal occult blood determination device 31 assembled as shown in FIG.
Remove the stopper 39 of. Then, the stool collection tool 32 is pulled out from the buffer solution container 33.

Next, as shown in FIG. 8A, the stool collection device main body 32b of the stool collection device 32 is pierced into the feces A to collect stool. In some cases, after the stool has been pierced and the stool collection device body 32b has been removed from the stool, excess stool attached to the stool holding portion 32c may be wiped off and removed. After that, the stool collection tool 32 is reinserted into the buffer solution container 33 (see FIG. 8B).

In this state, the buffer solution container 33 is swung,
In some cases, the stool sample is dissolved in the buffer solution 36 by inverting the entire occult blood determination device 31. Next, as shown in FIG. 8C, the operating portion 41 b of the sealing material penetrating member 41 is pressed from the outside of the elastic film 42 with a finger, and the needle-shaped portion 4 is pressed.
The liquid-tight seal material 34 (see FIG. 7) is pierced by the tip of 1a, and the fecal sample solution is introduced into the development layer installation portion 32d. The stool sample solution is introduced by the capillary phenomenon because the separation filter 37 is made of a porous material or the above-mentioned filter material.

Next, the stool collection device 32 is pulled up and the determination by immunochromatography is started (see FIG. 9 (a)). That is, the stool sample solution enters the development layer installation portion 32d, and the solid content is removed by the separation filter 37. The stool sample solution from which the solid content has been removed permeates the developing layer 38 from the starting end 38a and diffuses on the developing layer 38. The stool sample solution moves upward on the spreading layer 38 together with the first antibody-sensitized carrier. At this time, when human hemoglobin is contained in the stool sample solution, an antigen-antibody reaction occurs with the first antibody on the carrier. As a result, the human hemoglobin-first antibody-sensitized carrier complex moves upward, and only the human hemoglobin-adsorbing carrier causes an antigen-antibody reaction with the second antibody at the site where the second antibody is located, as described above. To be trapped.

On the other hand, when human hemoglobin was not contained in the stool lysate, human hemoglobin-first
The antibody-sensitized carrier complex is not trapped by the second antibody and all moves to the portion where the end window 32f of the spreading layer 38 is located. Therefore, by observing through the determination window 32e, the color tone of the carrier is observed when the hemoglobin is contained in the stool lysate (positive), and it is not observed when it is not contained (negative: development layer). The color of the ground of 38 remains the same).

The judgment window 32e is not limited in shape or size as long as it is arranged at a position where the above judgment can be clearly observed. The end of the determination is performed by observing the spreading layer 38 through the end window 32f, and at the stage when the determination is completed, the sealing plug 39 is attached to the communication hole 32g to prevent the liquid of the fecal dissolution liquid from leaking, and the measurement is completed ( See FIG. 9B).

Fourth Embodiment FIG. 10 is a partially cutaway vertical sectional view showing a fecal occult blood determining apparatus according to a fourth embodiment of the present invention. The present embodiment corresponds to the embodiment according to the invention described in claim 3.

The fecal occult blood determination apparatus 51 of this embodiment has a fecal sampling device 52 and a buffer solution container 53. Stool collection equipment 52
Has a lid 54 and a substantially columnar stool collection instrument body 55 having a diameter smaller than that of the lid 54.

At the tip of the body 55 of the stool collecting device, the stool holding portion 5 is provided.
5a is formed. The stool holder 55a has the same structure as the stool holder 5a of the first embodiment. In addition, the stool collection device main body 55 has a first communication hole 57 extending in the length direction.
Are formed. The first communication hole 57 is used for the fecal sampling device 52.
Is formed so that the inside of the buffer solution container 53 and the outside air communicate with each other in a state in which is inserted into the buffer solution container 53. A plug 58 is attached to the upper end of the first communication hole 57.

Inside the stool collection device main body 55, there is formed a development layer installation section 60 which opens downward. Development layer installation unit 60
As shown in the figure, is formed as a space that extends in the length direction of the feces sampling instrument body 55 and opens downward.

The lower opening of the developed layer installation portion 60 is closed by a liquid-tight seal material 62. This liquid-tight sealing material 6
2 is configured similarly to the liquid-tight seal material 12 used in the first embodiment and has the same function.

A separation filter 65 is arranged above the liquid-tight seal material 62. The separation filter 65 is attached such that the outer peripheral surface thereof is in close contact with the inner peripheral surface of the development layer installation portion 60, and the separation filter 15 used in the first embodiment is used.
It is made of the same material as and has the same function.

In the development layer installation section 60, the development layer 66 is provided above the separation filter 65. The development layer 66 is arranged so that its start end 66 a is above the separation filter 65. Therefore, the separation filter 6
The stool sample solution from which the solid content was removed by 5 is the start end 6
Penetrates 6a. On the other hand, in the stool collection device body 55, a determination window 55b and an end window 55c are formed in order to allow the inner development layer 66 to be observed from the outside.
In FIG. 10, only the positions where the judgment window 55b and the end window 55c are provided are schematically shown by circles, but these judgment windows 55b
The b and the end window 55c are configured similarly to the judgment window 32e and the end window 32f formed in the fecal occult blood judging device of the third embodiment.

Preferably, the judgment window 55b and the end window 55
With respect to c as well, it is liquid-tightly closed by a transparent material, so that liquid leakage can be prevented. As such a transparent material, a transparent polymer material such as polyethylene or polyvinyl chloride can be used.

The spreading layer 66 is provided for carrying out a known immunochromatography, and is a third layer.
The structure is similar to that of the spreading layer 38 used in the embodiment.
Therefore, the description of the development layer 66 will be omitted by incorporating the description of the development layer 38.

The buffer solution container 53 has the same structure as the buffer solution container 3 used in the first embodiment. That is, the projection 63 is formed on the inner surface of the bottom of the buffer solution container 53 so as to project upward. The protruding portion 63 is provided to break through the liquid-tight sealing material 62. Also,
A buffer solution 64 is stored in the buffer solution container 53, but the buffer solution 64 can also be made of the same material and capacity as the buffer solution 14 used in the first embodiment.

As is apparent from the above description, the fecal occult blood determining apparatus 51 of the fourth embodiment is the same as the fecal occult blood determining apparatus 1 of the first embodiment and the third embodiment using the immunochromatographic method. This corresponds to a structure in which the fecal occult blood determination device 31 is combined.

The method of using the fecal occult blood determination device 51 is shown in FIG.
~ It demonstrates with reference to FIG. First, the stopper 58 of the fecal occult blood determination device 51 shown in FIG. 10 is removed. Then, the stool collection device 52 is pulled out from the buffer solution container 53.

Next, as shown in FIG. 11 (a), the stool collection device 52 is inserted into the feces A to collect stool. In some cases, after the stool has been pierced and the stool collection device main body 55 has been removed, excess stool attached to the stool holding portion 55a may be wiped off and removed. After that, the fecal sampling device 52 is inserted again into the buffer solution container 53 (see FIG. 11B).

In this state, the buffer solution container 53 is swung,
In some cases, after the stopper 58 is attached, the feces occult blood determination device 51 is turned over to turn the feces sample into the buffer 64
Dissolve in.

Next, as shown in FIG. 12, the stool collection device 52
Is further pushed into the buffer solution container 53, and the liquid-tight sealing material 6
2 (see FIG. 1) is pierced by the protrusion 63. As a result, the stool sample solution will flow into the spreading layer installation section 60 in the stool collection instrument body 55. The inflowing stool sample solution is filtered by the separation filter 65 shown in FIG. 10, and the filtered stool sample solution is supplied from the starting end 66a of the spreading layer 66 by the capillary phenomenon.

Next, as shown in FIG. 13, the stool collection device 52
Is moved upward to expose the determination window 55b and the end window 55c above the buffer solution container 53. The stool sample solution from which the solid content has been removed diffuses from the starting end 66a onto the developing layer 66, and moves upward on the developing layer 66 together with the first antibody-sensitized carrier. At this time, when human hemoglobin is contained in the stool sample solution, an antigen-antibody reaction occurs with the first antibody on the carrier. As a result, a human hemoglobin-first antibody-sensitized carrier complex is generated, the immune complex moves upward, and at the site where the second anti-hemoglobin antibody is immobilized, the immune complex forms a second antibody. An antigen-antibody reaction occurs and is trapped.

On the other hand, when human hemoglobin was not contained in the stool sample lysate, the above immune complex did not occur, and the first antibody-sensitized carrier was not trapped by the second antibody, and all developed. It will move on the layer 66 to the part where the end window 55c is located.

Therefore, when observed from the judgment window 55b, the color tone of the carrier is observed (positive) when human hemoglobin is contained in the stool sample solution, and when it is not contained, the color tone of the carrier is observed. Will not be observed (negative: the ground color of the spreading layer 66 remains the same).

The judgment window 55b is not limited in shape or size as long as it is arranged at a position where the above judgment can be clearly observed. The end of the determination is performed by observing the development layer 66 through the end window 55c. At the stage when the determination is completed, the stool collection instrument 52 is again inserted into the buffer solution container 53, and the stopper 58 is attached to the communication hole 57. The measurement can be completed while preventing the leakage of the stool sample solution (see FIG. 14).

Fifth Embodiment FIG. 15 is a vertical sectional view showing a fecal occult blood determining apparatus according to an embodiment of the present invention.

The fecal occult blood determining apparatus 71 of this embodiment has a fecal sampling instrument 72 and a buffer solution container 73. The stool collection device 72 is
The lid 74 is made of synthetic resin, and has a substantially columnar stool collection instrument main body 75 having a diameter smaller than that of the lid 74. Inside the lid 74, a recess 74a that opens upward is formed. The recess 74a has an upper lid 74 that is openably and closably attached.
It is closed by b. Also, on the side wall of the lid 74,
A through hole 74c is formed, and a plug 76 is attached so as to close the through hole 74c.

At the tip of the stool collection device main body 75, the stool holding portion 7
5a is formed. The stool holding portion 75a is formed by giving unevenness to the outer peripheral surface, and is provided for semi-quantitatively collecting stool. The shape of the stool holding portion 75a is not limited to the shape shown in the figure, and various shapes such as depressions and protrusions may be used as long as semi-quantitative stool can be collected. Moreover, the number of such depressions and protrusions is not particularly limited.

On the other hand, a communication hole 77 extending in the length direction is formed in the main body 75 of the stool collection instrument. The communication hole 77 is
It is formed in order to facilitate the operation by connecting the filter installation portion 80 and the outside air in a state where the feces collecting instrument 72 is inserted into the buffer solution container 73. The upper end of the communication hole 77 has the lid 7 described above.
4 is open in the recess 74a, and a plug 78 is attached to the open portion of the communication hole 77.

A filter installation section 80 is provided in the main body 75 of the stool collection instrument. The lower end of the communication hole 77 is open to the filter installation portion 80. On the other hand, an opening 81 for introducing a solution in which the stool sample has been dissolved is formed in the lower portion of the filter installation portion 80. The opening 81 is closed by a liquid-tight seal material 82. Liquid tight sealing material 8
No. 2 needs to have a strength that is not easily broken in order to collect a stool sample, but is made of a material that can be easily pierced by a sealing material penetrating member described later.

The liquid-tight sealing material 82 is, for example, a synthetic resin film such as a polyethylene film or a polypropylene film, a metal foil such as aluminum, or an appropriate adhesive such as a hot-melt adhesive or an adhesive on one surface of the laminate. It can be constituted by applying an agent.

The liquid-tight seal material 82 has a function of preventing the inflow of feces into the body 75 of the feces collecting instrument and a function of preventing the inflow of the buffer solution into the filter installation portion 80 at the time of collecting feces.

A separation filter 83 is arranged above the liquid-tight seal material 82. The separation filter 83 is provided to remove insoluble solids in the fecal sample solution. Therefore, the separation filter 83 is attached so that the outer peripheral surface thereof closely contacts the inner peripheral surface of the filter installation portion 80.

Since the separation filter 83 has the above-described filtration function, it can be constituted by a known filter paper, a separation membrane such as nitrocellulose, or a filter material. Moreover, the separation filter 83 may be made of a porous material such as a cellulose-based or synthetic polymer-based material.

An immune filter 84 is arranged above the separation filter 83. The immune filter 84 is provided to carry out a known immune filter method and uses a latex agglutination reaction. In the latex agglutination reaction method, for example, an immune product resulting from an antigen-antibody reaction between an antibody-sensitized latex and an antigen forms a three-dimensional network structure to generate an aggregate.

By carrying out the above-mentioned immunoreaction on a filter having a large number of pores through which aggregates cannot pass but non-aggregates can pass, the presence or absence of latex on the filter after the reaction, or on the filter Positive or negative is determined by the presence or absence of colored latex remaining in the space.

At the time of judgment, preferably, the color tone of the carrier is constituted so as to have a clear contrast with the immune filter or the space under the filter, whereby the judgment can be made more reliable and easy.

In the present invention, the above-mentioned antigen is human hemoglobin in the stool sample lysate, and the antibody is an anti-human hemoglobin antibody. The anti-human hemoglobin antibody is immobilized on the latex particles, but is immobilized so as to be soluble by the buffer container.

In the immunofilter 84, the product of the antigen-antibody reaction, that is, the aggregate does not pass through the immunofilter 84, but the antibody-sensitized carrier originally installed is dispersed in the fecal sample solution, It passes through the immune filter 84. As described above, if the color tone of the carrier and the color tone of the immune filter 84 or the space on the immune filter 84 have a clear contrast, positive and negative can be easily and surely determined.

In order to make the color tone of the carrier different from the color tone of the portion where the carrier is present and the color tone of the agglomerate, it is preferable to use a colored carrier. For example, it is preferable to use a white carrier when the background is black and a colored carrier when the background is white. Most preferred as the carrier is latex particles, but since latex particles are usually white, when the background is white, for example, styrene, latex particles obtained by emulsion polymerization of vinyltoluene, etc. And in a reaction medium containing an organic solvent compatible with water, a method of coloring by contacting with a poorly water-soluble colorant dissolved in the reaction medium, or obtained by emulsion polymerization and having an anionic functional group In an aqueous reaction medium, latex particles, for example, latex particles composed of a copolymer containing a monomer having an anionic functional group such as (meth) acrylic acid, are dissolved in the reaction medium, and the coloring agent is an amphoteric electrolyte. It is preferable to use latex particles obtained by a method of contacting with and coloring.

The anti-human hemoglobin antibody used in this example can be obtained by purifying the antiserum obtained by immunizing rabbits, sheep, goats, horses, guinea pigs, etc. with human hemoglobin by affinity chromatography or the like. . It is also possible to produce a monoclonal antibody by a known cell fusion method using immunized mouse spleen cells. In any case, it is desirable that the anti-human hemoglobin antibody used be sufficiently purified.

The anti-human Hb antibody can be sensitized to the carrier by a known method such as a separation adsorption method or a chemical binding method. For example, a buffer solution of anti-human Hb antibody is added to latex, and the mixture is stirred at 37 ° C. for 30 to 120 minutes.
The antibody can be physically adsorbed on the latex surface by heating to. If a latex having a carboxyl group is used, the antibody can be bound to the latex by a covalent bond via a water-soluble carbodiimide or the like. If necessary, bovine serum albumin (hereinafter referred to as "B
SA ”. ) And the like may be added.

Immunofilter 84 of the obtained antibody-sensitized carrier
Immobilization on the surface is performed by, for example, 0.01 to 10 of the antibody-sensitized carrier.
The weight% dispersion liquid may be dropped in an amount of about 0.05 to 1 ml at a predetermined position and dried at room temperature for 12 hours or more.

The buffer solution 85 contained in the buffer solution container 73 is preferably a neutral salt solution such as an ammonia buffer solution, a glycine buffer solution, a phosphate buffer solution or a Tris buffer solution, and particularly preferably. Has a pH of 6.5 to 8.5
The above buffer solution in the range of The amount of the buffer solution is preferably about 0.5 to 10 ml, though it depends on the amount of the stool sample to be collected.

The buffer solution container 73 has a bottomed cylindrical shape. A groove 73a extending in the circumferential direction is formed on the inner peripheral surface in the vicinity of the upper opening of the buffer solution container 73.
O-ring 8 made of synthetic rubber or natural rubber in 3a
6 are attached. The O-ring 86 is the stool collection device 72
Is provided in order to prevent the buffer solution container 85 from leaking by being pressed against the outer peripheral surface of the stool collection device main body 75 of the stool collection device 72 when inserted into the buffer solution container 73. That is, FIG.
In the state shown in (1), the O-ring 86 is provided to liquid-tightly seal the portion below the O-ring 86.

The side wall of the buffer solution container 73 has an opening 7
3b is provided, and a seal material penetrating member 87 is provided as a member for breaking through the liquid-tight seal material 82 at the portion where the opening 73b is provided. In this embodiment, the sealing material penetrating member 87 has a needle-shaped portion 87a protruding inward and a flat plate-shaped operation portion 87b connected to the needle-shaped portion 87a.

The seal member penetrating member 87 can be made of metal or relatively hard synthetic resin. The outer surface of the operating portion 87b of the sealing material penetrating member 87 is formed of the elastic film 8
It is pasted on 8. The elastic film 88 is provided to surround the seal member penetrating member 87 and prevent the buffer solution from leaking out from the buffer solution container 73. Therefore, the elastic film 88 has its peripheral portion fixed to the outer wall of the buffer solution container 73. The elastic film 88 can be made of, for example, synthetic rubber, natural rubber, or a synthetic resin film having elasticity.

Further, in the stool collection device main body 75, there is provided a second part for facilitating the work of inserting the stool collection device 72 into the buffer solution container 73 after the stool collection and the introduction of the stool sample solution into the filter installation portion. The communication hole 89 is formed so as to extend in the length direction. The upper end of the second communication hole 89 is open to the outer side wall of the stool collection device main body 75, and the plug 90 is attached to the open portion of the second communication hole 89.

The plugs 76, 78, 90 can be made of an appropriate synthetic resin such as polyethylene or vinyl chloride resin, synthetic rubber or natural rubber. In addition, in the present embodiment, the lid body 74 and the stool collection device main body 75 forming the stool collection device 72 are integrally formed of synthetic resin. Of course, the lid 74 and the body-collecting-apparatus main body 75 may be formed separately and may be joined together with an adhesive or the like. Further, the stool collection device 72 can be made of other appropriate material such as metal.

In addition, the stool collection instrument main body 75 and the buffer solution container 7
For No. 3, it is preferable that the immune filter 84 is made of a transparent synthetic resin material, glass, or the like in order to easily visually observe the result of the immune reaction from the outside. However, the immune filter 84
When a window is provided in the stool collection instrument main body 75 in a portion where the result of the immune filter method according to 1. can be confirmed, the stool collection instrument main body 75 may be made of a material having no transparency. When the window as described above is formed, it is necessary to close the window portion with transparent synthetic resin, glass or the like.

Further, the shape of the needle-shaped portion 87a of the sealing material penetrating member 87 is not limited to the illustrated shape as long as it can break through the liquid-tight sealing material 82, and it can be an appropriate shape and has a plurality of needles. It is also possible to provide a strip-shaped portion or the like.

The internal volume of the buffer solution container 73 is not particularly limited, but is usually about 1 to 10 ml in constructing the fecal occult blood determination device 71. The buffer solution container 73 can be made of an appropriate synthetic resin such as polyethylene, polypropylene, or vinyl chloride resin, but may be made of other materials such as glass or metal.

Next, a method of using the fecal occult blood determining apparatus shown in FIG. 15 will be described with reference to FIGS. 16 to 18. First, the faucet occult blood determination device 1 assembled as shown in FIG. 15 is unplugged, and then the fecal sampling device 72 is attached to the buffer solution container 7.
Pull out from 3.

Next, the stool sample main body 75 of the stool collection device 72 is pierced into the stool sample A and pulled out to remove the stool collection part 75.
A stool sample is collected in a (see FIG. 16 (a)). Next, after collecting the stool sample, the stool collection device 72 is again attached to the buffer container 73.
(See FIG. 16B). When the feces collecting instrument 72 is inserted into the buffer solution container 73, the O-ring 86
As a result, leakage of the buffer solution container 85 is prevented.

Next, as shown by the arrow C in FIG. 16 (b), the entire fecal occult blood determination device 71 is turned. By swirling, the stool sample is dissolved in the buffer solution 85. It should be noted that the present invention is not limited to turning, it may be tumbled, or appropriate vibration may be applied.

Thereafter, the plug 78 is removed, and as shown in FIG. 17, the sealing material penetrating member 8 is pressed from outside the elastic film 88 with a finger.
7 is pressed, and the liquid-tight seal material 82 is pierced by the needle-shaped portion 87a. As a result, the buffer solution 85 in which the stool sample is dissolved will flow into the filter installation section 80.

Next, after attaching the stopper 90 and removing the stopper 76, the entire fecal occult blood determining apparatus 71 is turned upside down. As a result, as shown in FIG. 18, the buffer solution in which the stool sample is dissolved is filtered by the separation filter 83 in the filter installation unit 80 and dropped on the immune filter 84.

In the immune filter 84, when the reaction proceeds according to the above-mentioned immunofilter method and human hemoglobin is present in the stool sample solution, an antigen-antibody reaction occurs on the immunofilter 84 and the immunosensitized carrier is used. An immune reaction product (aggregate) is generated by the reaction with human hemoglobin. Aggregates due to the antigen-antibody reaction do not flow into the determination space B (see FIG. 18) located below the immune filter 84. Therefore, the color tone of the antibody-sensitized carrier is not observed in the judgment space B (positive).

On the other hand, when human hemoglobin is not present in the stool sample solution, the antibody-sensitized carrier does not cause the above-mentioned antigen-antibody reaction. Therefore, the antibody-sensitized carrier together with the buffer solution in which the stool sample is dissolved passes through the immune filter 84 and reaches the space B. Therefore, in the judgment space B,
The color tone of the antibody-sensitized carrier is observed (negative).

Then, after the judgment is completed, the stoppers 76, 7
By attaching 8, 90, leakage of the stool sample solution is prevented and the measurement is completed. As described above, in the fecal occult blood determination apparatus 71 of the present embodiment, the fecal occult blood is collected by simply collecting a stool sample using the stool collection device main body 72, inserting the stool sample into the buffer solution container 73, and performing the above-described simple operation. It is possible to reliably and easily determine the presence or absence of.

Sixth Embodiment FIG. 19 is a vertical sectional view for explaining a fecal occult blood determining apparatus according to a sixth embodiment of the present invention. In the fecal occult blood determination device 91 of the sixth embodiment, the upper end of the communication hole 77 is opened at the center of the bottom surface of the recess of the lid 74. Here, the lid 74 is not provided with the upper lid 74b. Since the other points are similar to those of the fifth embodiment, the same parts are designated by the same reference numerals and the description thereof will be omitted.

In the sixth embodiment, at the upper end of the communication hole 77,
By connecting the vacuum suction source, the stool sample solution can be introduced into the filter installation unit 80 by vacuum suction. Therefore, the presence or absence of fecal occult blood can be determined more quickly.

In the above embodiment, the immune filter 84 is used.
As the above-mentioned anti-human hemoglobin antibody-sensitized carrier is movably installed by a buffer, and the anti-human hemoglobin antibody-sensitized carrier can pass, but the immune reaction between the anti-human hemoglobin antibody-sensitized carrier and human hemoglobin It was configured to have pores through which the product of
A second anti-human hemoglobin antibody having a recognition site different from that of the anti-human hemoglobin antibody, wherein an anti-human hemoglobin antibody-sensitized carrier is movably installed by a buffer solution in the filter installation part as described in claim 5. May be immovably immobilized, and the immunofilter may be configured to have pores through which the anti-human hemoglobin antibody-sensitized carrier can pass. When an anti-human hemoglobin antibody-sensitized carrier is movably installed in this way and an immobilizing second antibody having a different epitope is immobilized,
Since the second antibody is immobilized in the immunofilter, the immunoreaction product is trapped on the immunofilter by the sandwich method with hemoglobin (positive). On the other hand, since the human hemoglobin antibody-sensitized carrier passes through the immunofilter, the color tone of the antibody-sensitized carrier can be observed in the determination space B in the case of a stool sample containing no hemoglobin (negative). Therefore, by the immune filter method,
The presence or absence of fecal occult blood can be easily determined as in the above-mentioned examples.

Other Modifications In each of the above-described embodiments, the opening provided below the body of the stool collection device is closed by the liquid-tight sealing material, but in this case, preferably, the opening of the liquid-tight sealing material is used. A plurality of protrusions may be formed on the outer surface. This will be described with reference to FIGS. 20 and 21 by taking the liquid-tight seal material 12 of the first embodiment as an example.

As shown in the partially enlarged sectional view of FIG. 20, a plurality of protrusions 12a are formed on the lower surface of the liquid-tight seal material 12. The projections 12 a have a rectangular cross section and are dispersedly formed on the outer surface of the liquid-tight seal material 12. Therefore, a stool sample can be collected more reliably by the action of the plurality of protrusions 12a. That is, since the plurality of protrusions 8a can function as a feces holding portion, a feces sample can be semiquantitatively collected even on the outer surface of the liquid-tight seal material 12.

Although a plurality of protrusions 12a having a rectangular cross section is formed in FIG. 20, a plurality of protrusions 12b having a triangular cross section may be formed as shown in FIG. 21 (a). Alternatively, as shown in FIG. 21B, a rough surface layer 12 c whose surface state is rougher than that of the liquid-tight sealing material 12 may be laminated on the lower surface of the liquid-tight sealing material 12. In any case, a stool sample can be semi-quantitatively collected on the outer surface of the portion where the liquid-tight sealing material 12 is provided by the projection 12b and the rough surface layer 12c.

Although the modified example of the liquid-tight seal material 12 used in the first embodiment has been described, the protrusions 12a and 12b and the rough surface layer 12c as described above are used in the second embodiment. The liquid-tight seal material 34 used in the first to sixth embodiments, such as the liquid-tight seal material 34 used in the fourth embodiment and the liquid-tight seal material 62 used in the fourth embodiment, can also be applied. .

[0159]

As described above, according to the inventions described in claims 1 to 6, after the stool sample is collected in the stool holding portion of the stool collection device, the stool collection device is inserted into the buffer solution container. In the inventions of 1 to 3, the stool collection device is moved to the filter installation portion or the development layer installation portion, and in the inventions of claims 4 to 6, the filter material installation member or the deployment portion is expanded by operating the sealant penetrating member. A fecal sample solution can be introduced into the layer setting part. Further, the introduced stool sample solution is subjected to solid content removal by the separation filter and is supplied to the immunofilter or spreading layer, and the presence or absence of fecal occult blood is determined based on the immunofilter method or immunochromatography.

Therefore, according to the invention described in claims 1 to 6, it is possible to surely determine the presence or absence of fecal occult blood with an extremely simple operation and without requiring a great deal of skill. Further, in the inventions according to claims 1 to 6, the immune filter and the spreading layer are provided on the stool collection device side as described above, and the system is constituted only by the stool collection device and the buffer container. In addition, the structure of the fecal occult blood device can be simplified, and the fecal occult blood test device can be downsized.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view of a fecal occult blood determining apparatus according to a first embodiment.

2 (a) to (c) are schematic diagrams for explaining the steps from collecting a stool sample and preparing a stool sample solution in the stool occult blood test apparatus of the first embodiment. Sectional view.

3 (a) and 3 (b) are schematic cross-sectional views for explaining a step of determining fecal occult blood using the fecal occult blood determining apparatus of the first embodiment.

FIG. 4 is a partially cutaway cross-sectional view showing an example in which a structure for introducing a fecal sample solution is provided in the lid body as a modified example of the first embodiment.

FIG. 5 is a partially cutaway side view for explaining another modification of the structure for introducing the stool sample solution.

FIG. 6 is a partially cutaway side view for explaining another modification of the structure for introducing the stool sample solution.

FIG. 7 is a vertical cross-sectional view showing a fecal occult blood determination device of a third embodiment.

8 (a) to (c) are schematic views for explaining the steps from collecting a stool sample using the stool occult blood determination apparatus of the third embodiment to preparing a stool sample solution. Sectional view.

9 (a) and 9 (b) are schematic cross-sectional views for explaining the work of making a determination using the fecal occult blood determining apparatus of the third embodiment.

FIG. 10 is a vertical cross-sectional view showing a fecal occult blood determination device of a fourth embodiment.

11 (a) and 11 (b) are schematic cross-sectional views for explaining a step of collecting a stool sample and a step of preparing a stool sample solution using the fecal occult blood determination apparatus of the fourth embodiment. Fig.

FIG. 12 is a schematic cross-sectional view for explaining a step of breaking through the liquid-tight sealing material in the fecal occult blood determination apparatus of the fourth example.

FIG. 13 is a schematic cross-sectional view for explaining an operation of making a determination using the fecal occult blood determining apparatus of the fourth embodiment.

FIG. 14 is a schematic cross-sectional view for explaining a work ending step after performing a determination operation using the fecal occult blood determining apparatus of the fourth embodiment.

FIG. 15 is a vertical cross-sectional view of the fecal occult blood determining apparatus according to the fifth embodiment of the present invention.

16 (a) and 16 (b) are schematic cross-sectional views for explaining a step of collecting a stool sample and a step of preparing a stool sample solution in the fecal occult blood determination apparatus of the fifth embodiment. .

FIG. 17 is a cross-sectional view for explaining a step of breaking the sealing material using the fecal occult blood determining apparatus of the fifth embodiment.

FIG. 18 is a schematic cross-sectional view for explaining a step of making a determination in the fecal occult blood determining apparatus of the fifth embodiment.

FIG. 19 is a vertical cross-sectional view of the fecal occult blood determination device of the sixth embodiment.

FIG. 20 is a partial cutaway sectional view for explaining a modified example of the liquid-tight sealing material.

21A and 21B are cross-sectional views for explaining another modification of the liquid-tight sealing material.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Fecal occult blood determination device 2 ... Stool collection device 3 ... Buffer container 5a ... Stool collection part 7 ... 1st communication hole 9 ... 2nd communication hole 10 ... Filter installation part 12 ... Liquid-tight sealing material 13 ... Projection part 15 ... Separation filter 16 ... Immune filter 31 ... Fecal occult blood determination device 32 ... Stool collection device 32d ... Deployment layer installation part 32e ... Judgment window 32f ... End window 32g ... Communication hole 33 ... Buffer container 34 ... Liquid-tight sealing material 36 ... Buffer solution 37 ... Separation filter 38 ... Development layer 41 ... Seal material penetrating member 51 ... Fecal occult blood determination device 52 ... Stool collection device 53 ... Buffer container 55 ... Stool collection device body 55a ... Stool holding part 55b ... Judgment window 55c ... End Window 57 ... Communication hole 60 ... Development layer installation part 62 ... Liquid-tight sealing material 63 ... Projection part 64 ... Buffer solution 65 ... Separation filter 66 ... Development layer 71, 91 ... Fecal occult blood determination device 72 ... Stool collection device 73 ... Buffer solution Container 7 4 ... Lid body 75 ... Stool collection device main body 75a ... Stool collection part 77, 89 ... Communication hole 80 ... Filter installation part 81 ... Opening 82 ... Liquid-tight sealing material 83 ... Separation filter 84 ... Immune filter 85 ... Buffer solution 87 ... Seal Material penetrating member 88 ... Elastic film

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Yuji Kaneko 2-1 Hyakuyama, Shimamoto-cho, Mishima-gun, Osaka Prefecture Sekisui Chemical Co., Ltd. (72) Takuya Wada 2-1 Hyakuyama, Shimamoto-cho, Mishima-gun, Osaka 2-1 Sekisui Chemical Industry Co., Ltd.

Claims (6)

[Claims] 1. A fecal occult blood determination apparatus comprising: a stool collection device having a stool holding part for holding collected stool attached to an outer surface thereof, and a buffer container into which the stool collection device is inserted from above. In the stool collection device, a first communication hole that allows the outside air to communicate with the inside of the buffer solution container when inserted into the buffer solution container, a filter installation part opened downward, the filter installation part and the outside air A second communication hole that connects the liquid-tight sealing material and a liquid-tight sealing material that are attached so as to close the opening below the filter installation portion; A separation filter which is arranged above and for removing solids in the buffer solution in which the stool sample is dissolved, and which is arranged above the separation filter in the filter installation section, and sensitized with an anti-hemoglobin antibody. Carrier buffer And an anti-hemoglobin antibody-sensitized carrier that can pass through, but the product of the antigen-antibody reaction between the anti-hemoglobin antibody-sensitized carrier and hemoglobin does not pass through an immune filter having pores. Further provided is a fecal occult blood determining apparatus, wherein the buffer solution container is provided with a protruding portion for breaking the liquid-tight sealing material by moving the stool collection device. 2. A fecal occult blood determination apparatus comprising: a stool collection device having a stool holding portion for holding collected stool attached to an outer surface thereof, and a buffer container into which the stool collection device is inserted from above. In the stool collection device, a first communication hole that allows the outside air to communicate with the inside of the buffer solution container when inserted into the buffer solution container, a filter installation part opened downward, the filter installation part and the outside air A second communication hole that connects the liquid-tight sealing material and a liquid-tight sealing material that are attached so as to close the opening below the filter installation portion; A separation filter arranged above, for removing solids in the buffer solution in which the stool sample is dissolved, and an anti-hemoglobin antibody-sensitized carrier movably arranged by the buffer solution in the filter installation part, , The above anti-hemoglobi A second anti-hemoglobin antibody having a recognition site different from that of the antibody is immobilized immovably, and further comprises an immunofilter having pores through which the anti-hemoglobin antibody-sensitized carrier can pass, the buffer container Is a fecal occult blood determining apparatus, wherein a protrusion for breaking the liquid-tight sealing material is formed by moving the fecal sampling device. 3. A fecal occult blood determination apparatus comprising: a stool collection device having a stool holding part for holding collected stool attached to an outer surface thereof, and a buffer container into which the stool collection device is inserted from above. The fecal sampling device is provided with a first communication hole that communicates the outside air with the inside of the buffer solution container when inserted into the buffer solution container, and a development layer installation portion that opens downward, A liquid-tight seal material attached so as to close an opening below the development layer installation part, and a buffer which is arranged above the liquid-tight seal material in the development layer installation part and in which a stool sample is dissolved. Separation filter for removing the solid content in the liquid, and is arranged above the separation filter, and the anti-hemoglobin antibody sensitized carrier is installed, the development layer anti-hemoglobin antibody is immobilized and Further comprising: A judgment window and an end window are formed to allow the development layer to be observed from the outside, and the buffer container is to break the liquid-tight sealing material by moving the stool collection instrument. An apparatus for determining fecal occult blood, characterized in that a protrusion is formed on the feces. 4. A fecal occult blood determination apparatus comprising: a stool collection device having a stool holding portion that holds collected stool by attaching it to an outer surface, and a buffer container into which the stool collection device is inserted. In the stool collection device, a filter installation part having an opening,
A communication hole that communicates the filter installation portion and the outside air is formed, and a liquid-tight seal material attached to the stool collection device so as to close the opening of the filter installation portion, and in the filter installation portion A separation filter, which is arranged above the liquid-tight sealing material, removes solids in the buffer solution in which the stool sample is dissolved, and is arranged above the separation filter in the filter installation section, and The anti-hemoglobin antibody-sensitized carrier is movably installed by a buffer, and the anti-hemoglobin antibody-sensitized carrier can pass through, but the product of the antigen-antibody reaction between the anti-hemoglobin antibody-sensitized carrier and hemoglobin passes through. In order to make it possible to break the liquid-tight seal material by an external operation, the immune filter has pores that do not extend in the direction of the liquid-tight seal material. The fecal occult blood determining apparatus further comprising: a sealant penetrating member attached to the buffer solution container such that the tip is extended to the liquid-tight sealant side. 5. A fecal occult blood determination apparatus comprising: a stool collection device having a stool holding part for holding collected stool attached to an outer surface thereof, and a buffer solution container into which the stool collection device is inserted. In the stool collection device, a filter installation part having an opening,
A communication hole that communicates the filter installation portion and the outside air is formed, and a liquid-tight seal material attached to the stool collection device so as to close the opening of the filter installation portion, and in the filter installation portion A separation filter, which is arranged above the liquid-tight sealing material, for removing solids in the buffer solution in which the stool sample is dissolved, and an anti-hemoglobin movably installed in the filter installation section by the buffer solution. An antibody-sensitized carrier, an second anti-hemoglobin antibody having a recognition site different from that of the anti-hemoglobin antibody, is immobilized immovably, and an immunofilter having pores through which the anti-hemoglobin antibody-sensitized carrier can pass. , The tip is extended in the direction of the liquid-tight seal material so that the liquid-tight seal material can be broken by an external operation, and the tip is located on the liquid-tight seal material side. Ri said buffer fecal occult blood determination device for the sealant penetration member mounted, further comprising an on container as issued. 6. A fecal occult blood determination apparatus comprising: a stool collection device having a stool holding portion for holding collected stool attached to an outer surface thereof, and a buffer container into which the stool collection device is inserted from above. The fecal sampling device is formed with a communication hole that communicates the outside air with the inside of the buffer solution container when inserted into the buffer solution container, and a development layer installation portion that opens downward, the development layer It is arranged in the installation section, and the anti-hemoglobin antibody-sensitized carrier is installed, and the development layer on which the anti-hemoglobin antibody is immobilized, and the development layer installation section is arranged below the development layer. And a separation filter for filtering the buffer solution in which the stool sample is dissolved, and the separation filter is arranged below the separation filter in the development layer installation section, and the separation solution is installed in the development layer installation section for the buffer solution in which the stool sample is dissolved. Liquid to prevent the entry of In order to make it possible to break the sealing material and the liquid-tight sealing material from the outside, the tip is extended in the direction of the liquid-tight sealing material, and the tip is extended to the liquid-tight sealing material side. And a sealing material penetrating member attached to the buffer solution container so that a judgment window and an end window are formed in the stool collection instrument to allow the development layer to be observed from the outside. An apparatus for determining fecal occult blood, which is characterized in that