JP3519831B2 - Fecal occult blood determination device - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a simple fecal occult blood determining apparatus based on an immune reaction for determining the presence or absence of fecal occult blood.

[0002]

2. Description of the Related Art Fecal occult blood is produced by digestive system diseases resulting from the contamination of blood in the stool in the digestive tract. It has been confirmed that fecal occult blood is associated with diseases such as colorectal cancer in particular, and the fecal occult blood test 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 the dissolution is 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 utilizing an immune reaction, which has a relatively simple structure, but the operation is simplified over all steps of the fecal occult blood determination operation, and is unskilled. An object of the present invention is to provide a fecal occult blood determining apparatus that enables a person to easily and accurately determine the presence or absence of fecal occult blood.

[0011]

The inventions set forth in claims 1 and 2 have been accomplished to achieve the above object,
A buffer container containing a buffer solution, and a stool collection device having a lid body attached to the buffer container so as to close the buffer container and a stool collecting rod connected to the lid body, In the lid, a determination tool introducing hole that penetrates the lid,
A sealing material is provided on the buffer solution container surface side of the determination tool introduction hole, and further provided so as to be attachable to the lid body,
A fecal occult blood determination apparatus including a determination tool configured to open the sealing material, further comprising the following configuration.

The judging device comprises a separation filter and a separation filter for removing solids in the buffer solution in which the stool sample that has flowed in due to the opening of the sealing material by the judging device. It is arranged so that the stool sample solution from which the solid content has been removed is supplied, and the anti-hemoglobin antibody sensitized carrier is installed and has a development layer on which the anti-hemoglobin antibody is immobilized. There is.

Further, in order to observe the presence or absence of fecal occult blood and the end of the determination from the outer surface of the determination tool, a spreading layer can be partially observed on the side wall of the determination tool main body. , A judgment window and an end window are formed.

According to a second aspect of the present invention, in addition to the above-mentioned structure, a state in which a determination tool introducing hole of the lid body is opened and a state in which the determination tool introduction hole of the lid body is opened are further provided. It is a fecal occult blood determination device to which a communication member configured so as to be attached is attached.

Further, in the inventions according to claims 1 and 2, the sealing material is capable of sealing a determination tool introducing hole penetrating the lid, and by a force applied from the determination tool. If it can be opened, it is not particularly limited,
For example, a synthetic resin film having an appropriate film thickness as shown in the below-mentioned first embodiment, a plug body as shown in the second embodiment, and the like can be mentioned.

(Operation) In determining fecal occult blood using the fecal occult blood determination apparatus according to the first and second aspects of the present invention, first, the fecal sampling rod portion of the fecal sampling device is pierced into the stool sample,
A stool sample is collected by withdrawing. After that, the stool collection rod is inserted into the buffer solution container, and the stool collection device is attached to the buffer solution 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 created.

According to the first and second aspects of the present invention, the judging tool provided separately from the stool collection tool is inserted into the judging tool introducing hole provided in the lid, and the sealing material is pierced at the tip of the judging tool. Or
In the case of a sealing material composed of a stopper, the stopper is removed at the tip of the determination tool to open the sealing material, and then the determination tool is brought into contact with the buffer solution in which the fecal sample is dissolved. After that, the buffer solution in which the stool sample is dissolved is filtered by a separation filter in the determination tool 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 spreading layer. Thereafter, in the spreading layer, as is clear from the description of Examples below, the presence or absence of fecal occult blood is determined according to the immunochromatographic method.

Further, in the inventions according to claims 1 and 2, since the determination window and the end window are formed in the determination tool, the determination can be easily performed from the outside and the completion of the determination can be confirmed. You can

As described above, in the inventions according to claims 1 and 2, after the stool sample is collected using the stool collection device and the stool collection device is attached to the buffer solution container, the stool sample is judged in the judgment tool introduction hole. The presence or absence of fecal occult blood can be easily determined by inserting the tool, opening the sealing material, and supplying the fecal sample solution to the determination tool. That is, since the fecal occult blood determining apparatus of the present invention has a relatively simple configuration, since the fecal sampling device, the buffer container and the determining device each have the above-described configuration, The determination of fecal occult blood can be reliably and easily performed.

According to the invention of claim 2, the structure of claim 1
In addition to the above, a stool equipped with a communication member configured so that the determination tool introducing hole of the lid body can be opened or closed from the side surface of the lid body to the inside. It is an occult blood determination device, and since the determination member introducing hole can be opened and closed by the communication member, each operation during use can be reliably performed as shown in Examples described later. .

[0021]

BEST MODE FOR CARRYING OUT THE INVENTION The present invention will be clarified by describing non-limiting examples of the present invention with reference to the drawings.

First Embodiment FIG. 1 is a longitudinal sectional view for explaining a fecal occult blood determining apparatus according to an embodiment of the present invention. However,
The front view is shown about the determination tool 4 in the inside. The fecal occult blood determination apparatus 1 of the present embodiment includes a fecal sampling device 2 and a buffer solution container 3.
And the determination tool 4. Hereinafter, each member will be described in detail.

The stool collection device 2 has a lid 5 and a stool collection rod 6 connected to the lid 5. In the present embodiment, the lid body 5 and the stool collection rod 6 are integrally formed of synthetic resin. However, after the lid body 5 and the stool collection rod 6 are formed as separate members, they are fixed by an adhesive or the like. It may have been done.

The lid 5 is made of a cylindrical member whose top plate portion is thickened and which opens downward, and has an internal thread 5a formed on the inner peripheral surface of the cylindrical side wall. On the other hand, the stool collection rod 6 is connected to the lower surface of the top plate of the lid body 5 and is composed of an elongated cylindrical member. A stool collection part 6a is formed at the tip of the stool collection rod 6.

The stool collection part 6a is constructed by giving unevenness to the surface. The unevenness is provided for semi-quantitatively collecting the stool sample when the stool sample is stuck and pulled out. The stool collection unit 6a can be configured in any shape as long as it can semi-quantitatively collect a stool sample, and can be provided with depressions of various shapes or projections,
Alternatively, it can be configured by forming a hole. The buffer solution container 3 has a cylindrical container body 7 and a cylindrical mounting portion 8 provided at the upper end of the container body 7 and having an opening at the top. A male screw 8a is formed on the outer peripheral surface of the cylindrical mounting portion 8, and the male screw 8a is
It is formed so as to mesh with the female screw 5 a of the lid body 5.

A surplus feces removing member 9 is attached from the upper surface of the cylindrical attaching portion 8 toward the center. The surplus stool removing member 9 has a substantially conical shape provided so that the central side thereof extends downward, and a through hole 9a is formed at the lower end. Further, the excess feces removing member 9 is formed so as to cover almost the entire opening of the buffer solution container 3, except that a portion where a sealing material described later is located is opened. However, the area where the excess feces removing member 9 covers the opening of the buffer solution container 3 is not limited to this, and may be smaller. In addition, the excess stool removal member 9
Is made of synthetic resin or metal having an appropriate thickness so as to have elasticity, and has a slit formed around the through hole 9a. Therefore, when the stool collecting rod 6 is inserted through the through hole 9a, the through hole 9a of the surplus stool removing member 9 is inserted.
The peripheral edge portion facing to the abutment portion is brought into contact with the outer surface of the stool collection portion 6a. Therefore, the surplus stool sample among the stool samples attached to the stool collection part 6a will be removed at the peripheral portion,
Of the stool samples collected by the stool collection unit 6, only a predetermined amount of stool sample is inserted into the buffer solution container 3.

A buffer solution 10 is stored inside the buffer solution container 3. As the buffer solution 10, for example, a near neutral salt solution such as an ammonia buffer solution, a glycine buffer solution, a phosphate buffer solution, a Tris buffer solution is preferable, and particularly preferably,
The said buffer solution of pH = 6.5-8.5 is mentioned. The amount of buffer solution is preferably about 0.5 to 10 ml, though it depends on the amount of the stool sample to be collected.

The lid 5 is provided with a judging tool introducing hole 11 having a circular cross section, which penetrates through the covering 5, and a sealing for sealing the judging tool introducing hole 11 on the buffer solution container surface side of the judging tool introducing hole 11. Material 12 is provided. The encapsulant 12 is made of a material that can be pierced by an encapsulant opening 15b provided at a lower end of a determination tool body 15 of the determination tool 4 described later. As such a material, a synthetic resin film having an appropriate film thickness, hot melt heat seal, or the like is used. Judgment tool introduction hole 1
A female screw 11a that meshes with a male screw 15a, which will be described later, of the determination tool 4 is formed on the upper portion of the determination tool 4, and a donut-shaped elastic packing 13 is fixed to the lower portion of the female screw 11a.
The inner diameter of the elastic packing 13 is equal to the judging tool body 1 of the judging tool 4.
It is made slightly smaller than the outer diameter of 5, so that the judging tool main body 15 can be fixed at a desired position in the judging tool introducing hole 11. The elastic packing 13 is made of, for example, synthetic rubber,
An elastic synthetic resin film or the like is used.

The judging tool 4 comprises a judging tool main body 15 and an operating section 16.
Consists of. The judging tool main body 15 is made of a hollow cylindrical body having an outer diameter slightly smaller than the diameter of the judging tool introducing port 11, and a male screw 15a is formed on the operating portion 16 side. A needle-like sealing material open portion 15b having a tip protruding outward is formed at the lower end of the. As a material for forming the determination tool 4, for example, a relatively hard synthetic resin or metal is used. The determination tool 4 is inserted into the determination tool introduction port 11 as described later, and the sealing material opening portion 15 is inserted.
The sealing material 12 is opened at b, and the vicinity of its tip is introduced into the buffer solution container body 7 and brought into contact with the fecal dissolution solution for use. When the sealing material 12 is opened by the sealing material opening portion 15b, the operating portion 16 is used as a knob, the determination tool 4 is rotated, and the male screw 15a is meshed with the female screw 11a. The sealing material 12 is pierced at the sealing material opening portion 15b.

The sealant opening 15 at the bottom of the judging tool body 15
A sample introduction hole 17 is provided in the vicinity of b, and the introduction hole 17
Is provided with a separation filter 18. The separation filter 18 is provided to remove the solid content in the buffer solution in which the stool sample is dissolved, and can be composed of, for example, a known filter paper, a separation membrane such as nitrocellulose, or a filter material. Further, the separation filter 18 may be made of a porous material made of a cellulosic material or a synthetic polymer material.

A development layer 19 for determining the presence or absence of fecal occult blood in the stool sample based on the principle of immunochromatography is provided in the main body 15 of the judging device. The shape of the development layer 19 is such that when the determination tool 4 is set upright,
The lower end of the is not particularly limited as long as it can pass through the separation filter 18 and come into contact with the stool sample solution supplied from the sample introduction hole 17, and examples thereof include a columnar shape and a strip shape. Can be mentioned. Further, the development layer 19 does not necessarily need to be fixed to the side wall inside the determination tool body 15.

Further, a judgment window 20 and an end window 21 are formed on the side wall of the judgment tool main body 15 in order to make it possible to partially observe the development layer 19. End window 21
Are formed above the determination window 20. The determination window 20 and the end window 21 are each closed by a transparent film. As such a film, an appropriate synthetic polymer film such as polyethylene, polyvinyl chloride or polypropylene can be used.

As described above, the spreading layer 19 is provided to carry out the 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 a first antibody) is installed at the starting end 19a. 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 19a of the spread layer, the sample moves on the spread layer 19,
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, due to the antigen-antibody reaction between the test substance and the second antibody, 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 19, 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 forming the spreading layer 19, 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 membrane. Various materials used as the filter material can be used.

Further, the spreading layer 19 needs 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 19 is black and a colored carrier when the developing layer 19 is white. The most preferred carrier is latex particles, but since latex particles are usually white, when the background is white,
For example, (1) a latex particle obtained by emulsion polymerization of styrene, vinyltoluene, or the like is dissolved in a reaction medium containing water and an organic solvent having compatibility with water, and is hardly water-soluble. A method of coloring by contacting with a coloring agent,
(2) Latex particles obtained by emulsion polymerization and having an anionic functional group, for example, latex particles made of a copolymer containing a monomer having an anionic functional group such as (meth) acrylic acid, in an aqueous reaction medium. It is preferable to use colored latex particles obtained by a method of coloring by contacting with a colorant which is an ampholyte dissolved in the reaction medium.

The anti-human Hb antibody used in the present invention (first
Antibodies) can be obtained by purifying antisera obtained by immunizing rabbits, sheep, goats, horses, guinea pigs, etc. with human Hb 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 Hb antibody used be sufficiently purified.

The anti-human Hb antibody can be sensitized to the carrier by a known method such as a physical 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 obtained first antibody-sensitized carrier is placed on the spreading layer 19, for example, a 0.01-10% by weight dispersion of the antibody-sensitized carrier is added in a predetermined amount of about 0.05-1 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 19, the judgment window 20
The second antibody is immobilized on the site 19b observed by. As the second antibody, an anti-human hemoglobin antibody having a different epitope recognized by the first antibody can be used.
As the immobilization method, 1 to 5 mg / ml of the second antibody 0.1
An example is a method of dropping -10 μl to a predetermined position, allowing it to stand at room temperature for 12 hours or more, and further dropping BSA or the like to the same position if necessary and drying.

In the fecal occult blood determining apparatus of the present embodiment, the above-mentioned stool collection device 2 is entirely made of synthetic resin material, but it may be made of other material such as metal. The inner volume of the buffer solution container 3 is not particularly limited, but it is preferably about 1 to 10 ml in terms of downsizing of the device.

The buffer container 3 can be made of 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. 1 will be described with reference to FIGS. 1 and 2. Note that FIG.
FIG. 4 is a diagram schematically showing only a main part of the fecal occult blood determination device to explain how to use the device.For example, a part that is originally invisible from the outside is also shown by a solid line and drawn according to a drawing method. It is not a drawing.

First, in the fecal occult blood determining apparatus 1 assembled as shown in FIG. 1, the fecal sampling device 2 is removed from the buffer solution container 3. Next, the stool sample 6 of the stool collection tool 2 is pierced into the stool sample A and pulled out to collect the stool sample in the stool collection part 6a (see FIG. 2 (a)).

Next, after collecting a stool sample, the stool collection device 2 is attached to the buffer solution container 3 again (see FIG. 2 (b)). At the time of this attachment, the surplus feces removing member 9 shown in FIG.
Thus, the excess amount of the stool sample is removed, and the predetermined amount of the stool sample is immersed in the buffer solution 10 while being held in the stool collection unit 6a. Further, by engaging the female screw 5a of the lid 5 with the male screw 8a of the buffer solution container 3, the buffer solution 10 is prevented from leaking to the outside. In this state, the entire fecal occult blood determination device 1 is turned as shown by the arrow in FIG.
By the turning, the stool sample held in the stool collection part 6a is dissolved in the buffer solution 10. After that, as shown in FIG. 2C, the determination tool 4 is inserted into the determination tool introduction hole 11, and the operation portion 16 is inserted.
Use as a knob, rotate the judgment tool 4, and
By meshing 5a with the female screw 11a, the sealing material 12 is pierced by the sealing material opening portion 15b, and the determination tool 4 is further lowered to project the sample introduction hole 17 into the buffer solution 10.

Thereafter, the solid content in the stool sample solution is removed by the separation filter 18 in the sample introduction hole 17, and the stool sample solution from which the solid content is removed is supplied to the starting end 19a of the spreading layer 19. .

Next, as shown in FIG.
Then, the inside of the determination tool introducing hole 11 is pulled up and stopped at the desired arbitrary position by the elastic packing 13. Deployment layer 1
In 9 the immunochromatography was started and the buffer solution in which the stool sample was dissolved was developed by the capillary phenomenon.
It diffuses upward and moves toward the end window 21 side together with the first antibody-sensitized carrier. At this time, when human hemoglobin is contained in the buffer solution in which the stool sample is dissolved, an antigen-antibody reaction occurs with the first antibody on the carrier. And
At the site where the second antibody is located, only the human hemoglobin-adsorbing carrier causes an antigen-antibody reaction with the second antibody and is trapped (sandwich method). On the other hand, when human hemoglobin is not contained in the buffer solution in which the stool sample is dissolved, the first antibody-sensitized carrier is not trapped by the second antibody.
That is, the first antibody-sensitized carrier is entirely moved to the end window 21 of the spreading layer 19 along with the buffer solution. Therefore, when observed from the judgment window 20, the color tone of the carrier is observed when the hemoglobin in the stool sample solution contains human hemoglobin (positive), and when it does not contain it, the development layer. Only 19 colors are observed (negative).
Therefore, the presence or absence of fecal occult blood can be easily determined by visually observing through the determination window 20.

The determination window 20 need only be installed at a position where the above determination can be clearly observed, and its shape and size are not particularly limited. The determination is completed by observing the development layer 19 through the end window 21 and confirming that the buffer solution has reached the development layer in this portion.

After the judgment is completed, as shown in FIG.
The determination tool 4 is fully inserted into the determination tool introduction hole 11 and the female screw 11a and the male screw 15a are engaged with each other so that the fecal sample solution does not leak outside the fecal occult blood determination device 1 and is subjected to a disposal process. It

Second Embodiment FIG. 3 is a vertical sectional view for explaining a fecal occult blood determining apparatus according to an embodiment of the present invention. However, the determination tool 24 in FIG. 3 is shown in a front view.

The fecal occult blood determination device 31 is composed of a stool collection device 22, a buffer solution container 23, and a determination tool 24. Before use, as shown in FIG.
It is attached to 3. The details of each member will be described below.

Regarding the stool collection device 22, a communication member, which will be described in detail below, is attached, no female screw is formed in the determination tool introduction hole, and no elastic packing is present, the shape of the sealing tool and the stool collection part. The stool collection device 2 is configured similarly to the stool collection device 2 of the first embodiment except that the shape and the like are different from those of the stool collection device 2 of the first embodiment. Therefore, the same parts are designated by the same reference numerals, and the description thereof will be omitted.

The buffer solution container 23 has the same structure as the buffer solution container 3 shown in the above embodiment.
Therefore, the description of the buffer solution container 23 will be omitted by giving the same reference numerals to the respective parts of the buffer solution container 3 of the first embodiment.

Further, the judging tool 24 is the same as the judging tool 4 of the first embodiment except that the shape of the operating portion, the shape of the opening of the sealing material, and the male screw, which will be described in detail below, are not provided. It is similarly configured. Therefore, the same parts are designated by the same reference numerals, and the description thereof will be omitted.

In this embodiment, the stool collection part 6a of the stool collection device 22.
Is different from that of the first embodiment in that a recess having a shape as shown in FIG. 3 is provided. Of the stool samples attached to the stool collection part 6a, the excess stool sample is removed at the peripheral part of the excess stool removal member 9 facing the through hole 9a, as in the first embodiment. Of the stool samples collected in
Only a predetermined amount of stool sample will be inserted into the buffer container 23 .

The lid 5 has a judgment tool introducing hole 11 having a circular cross section which penetrates the lid 5, and a sealing for sealing the judgment tool introducing hole 11 on the buffer solution container side of the judgment tool introducing hole 11. Material 12 is provided. The sealing material 12 is a plug that closes the determination tool introducing hole 11 unlike the sealing material of the first embodiment. The plug body is configured to drop downward when pressed by the sealing material opening portion 15b provided at the lower end portion of the determination tool body 15 of the determination tool 24.

A communication member introducing hole 25 is formed from the side surface of the lid 5 toward the inside. The communication member introducing hole 25
Is a cylindrical hole, and intersects with the determination tool introducing hole 11 at a position substantially in the center of the inside of the hole. A communication member 26 is fitted in the communication member introduction hole 25. The communication member 26 is configured so that the determination tool introducing hole 11 can be opened or closed in the direction of the sealing material 12. That is, the communication member 26 is composed of an operating portion 27 and a cylindrical rod-shaped body 28, and a hole 28a into which the determination tool main body 15 of the determination tool 24 can be inserted is formed in a substantially central portion of the rod-shaped body 28 in the longitudinal direction. When the rod-shaped body 28 is pressed to the inner side of the communication member introducing hole 25, the determining tool introducing hole 11 and the hole 2
8a are communicated with each other, the determination tool introduction hole 11 is opened in the direction of the sealing material 12, and the rod-shaped body 28 is connected with the communication member introduction hole 25.
When it is pulled from the back to the front, the determination tool introducing hole 11
The communication between the hole 28a and the hole 28a is blocked, and the determination tool introduction hole 11 is closed in the direction of the sealing material 12.

The rod-shaped body 28 is made of, for example, a material such as rubber, and when the communication member 26 is pressed to the back side and the determination tool introduction hole 11 is opened in the direction of the sealing material 12. Further, the communication member introducing hole 25 is configured to be tightly plugged with the base portion 28b of the rod-shaped body 28. The shape of the communication member introduction hole 25 is not limited to the cylindrical shape and the shape of the rod-shaped body 28 is not limited to the cylindrical shape. The communication member 26 opens the determination tool introduction hole 11 toward the sealing material 12. Any shape may be used as long as it can be configured to have a closed state and a closed state. For example, the communication member introduction hole 25 and the rod-shaped body 2
Each of the shapes of 8 may have a rectangular cross section. In addition, a removable stopper 29 is inserted between the operating portion 27 and the lid 5 in order to keep the determination tool introducing hole 11 closed in the direction of the sealing material 12 as necessary. Good.
The stopper 29 may be, for example, a rubber ring having a cut.

[0059]

The operating part 16 of the judging tool 24 is a spherical body having a diameter larger than the diameter of the judging tool introducing hole, and the diameter between the operating part 16 and the judging tool main body 15 is reduced. The judgment tool body 15 is moved to the buffer container 2 by folding the diameter part by hand.
It is designed so that it can be dropped into the inside.

At the lower end of the judging tool main body 15, there is formed an encapsulating material opening 15b having a tip protruding outward. As a material for forming the judging tool main body 15 and the operating portion 16, for example, a relatively hard synthetic resin or metal is used. The determination tool 24 is inserted into the determination tool introduction hole 11, and the communication member 26 causes the determination tool introduction hole 11 to open in the direction of the sealing material 12, and then is sealed by applying a force from the outside. After the sealing material 12 is pressed by the material opening portion 15b and the sealing material 12 is dropped into the buffer solution container body 7 , the vicinity of the tip of the determination tool 24 is introduced into the buffer solution container body 7 and the fecal dissolution liquid Used in contact.

The sealant opening 15 at the bottom of the judging tool body 15
A sample introduction hole 17 is provided in the vicinity of b, and the introduction hole 17
Is the same as that of the first embodiment, and that the separating filter 18 is provided in the determination tool body 15, and that the development layer 19 having the same configuration as that of the first embodiment is present in the determination tool body 15. Therefore, the fecal occult blood is determined in the same manner as in the first embodiment.

Next, a method of using the fecal occult blood determining apparatus shown in FIG. 3 will be described with reference to FIGS. 3 and 4. Note that FIG.
FIG. 4 is a diagram schematically showing only a main part of the fecal occult blood determination device to explain how to use the device.For example, a part that is originally invisible from the outside is also shown by a solid line and drawn according to a drawing method. It is not a drawing.

First, in the fecal occult blood determination device 31 assembled as shown in FIG. 3, the fecal sampling device 22 is removed from the buffer solution container 23. Next, the stool sample 6 of the stool collection tool 22 is pierced into the stool sample A and pulled out to collect the stool sample in the stool collection section 6a (see FIG. 4A).

Next, after collecting the stool sample, the stool collection device 22
Is again attached to the buffer solution container 23 (see FIG. 4B). At the time of this attachment, an excess amount of the stool sample is removed by the excess stool removal member 9 shown in FIG. 3, and a predetermined amount of the stool sample is immersed in the buffer solution 10 while being held in the stool collection part 6a. To be done. Further, the female screw 5a of the lid 5 is attached to the buffer solution container.
By engaging with the male screw 8a of No. 23 , the buffer solution 1
The leakage of 0 to the outside is prevented. In this state, the entire fecal occult blood determination device 31 is turned as shown by the arrow in FIG. By the turning, the stool sample held in the stool collection part 6a is dissolved in the buffer solution 10. Then, Figure 4
As shown in (c), the communication member 26 is pushed inward so that the determination tool introduction hole 11 and the hole 28a are communicated with each other, and the determination tool introduction hole 11 is opened in the direction of the sealing material 12.

Next, as shown in FIG.
4 is inserted into the determination tool introducing hole 11 and pressed as shown by an arrow B, and the sealing material (plug body) is pushed by the tip of the sealing material opening portion 15b.
After pressing 12 to drop the sealing material (plug) 12 into the buffer solution 10, the determination tool 24 is further lowered and the sample introduction hole 1
7 is plunged into the buffer solution 10. After that, the solid content in the stool sample solution is removed by the separation filter 18 of the sample introduction hole 17, and the stool sample solution from which the solid content is removed is developed layer 19.
Is supplied to the starting end 19a of the.

Next, as shown in FIG.
4 is pulled up in the determination tool introducing hole 11, and at the same time, the communication member 26 is pulled from the back to the front to block the communication between the determination tool introducing hole 11 and the hole 28a. The judgment tool main body 15 of the judgment tool 24 is placed on.

Then, in the spreading layer 19, immunochromatography is performed in the same manner as in the first embodiment,
The presence or absence of human hemoglobin in the stool sample lysate is determined.

After the completion of the determination, the reduced diameter portion between the operating portion 16 of the determination tool 24 and the determination tool main body 15 is manually folded, and the communication member 26 is pushed inward as shown in FIG. 4 (f). The introduction hole 11 and the hole 28a are communicated with each other, and the determination tool body 15 is dropped into the buffer solution container 23.

After that, the communication member 26 is pulled from the back to the front to cut off the communication between the determination tool introducing hole 11 and the hole 28a. Next, a stopper 29 is inserted between the operating portion 27 of the communication member 26 and the lid body 5, and the determination tool introducing hole 11 and the hole 28 are inserted.
The communication of “a” is blocked more surely, the stool sample solution is prevented from leaking to the outside of the fecal occult blood determination device 31, and the disposal process is performed.

[0071]

As described above, in the inventions described in claims 1 and 2, after the stool sample is collected on the stool collecting rod of the stool collecting instrument, the stool collecting rod is inserted into the buffer solution container to collect stool. After attaching the device to the buffer solution container, swirl or vibrate the entire fecal occult blood determination device to dissolve the stool sample in the buffer solution, and then operate the determination tool from the outside to bring it into contact with the stool sample solution. ,
The presence or absence of fecal occult blood is determined based on immunochromatography by simply performing a series of operations in which a stool sample is dissolved and a buffer solution containing no solid content is introduced into the development layer of the determination tool, and the presence or absence of fecal occult blood Can be easily observed from the outside through the judgment window.

Therefore, according to the first and second aspects of the present invention, it is possible to reliably determine the presence or absence of fecal occult blood with an extremely simple operation and without requiring a great deal of skill.

According to the second aspect of the present invention, since the communication member can be placed in the open state and the closed state of the determination tool introducing hole, each operation during use can be performed more reliably. .

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view of a fecal occult blood determining apparatus according to a first embodiment. However, the determination tool 4 is a front view.

2 (a) to 2 (e) are explanatory views schematically showing only a main part for explaining a method of using the fecal occult blood determining apparatus of the first embodiment.

FIG. 3 is a vertical cross-sectional view of a fecal occult blood determining device according to a second embodiment. However, the determination tool 24 is a front view.

4 (a) to 4 (f) are explanatory views schematically showing only a main part for explaining a method of using the fecal occult blood determination apparatus of the second embodiment.

[Explanation of symbols]

1, 31 Fecal occult blood determination device 2, 22 Stool collection device 3, 23 Buffer solution container 4, 24 Judgment tool 5 Lid body 6 Stool collection rod 7 Container body 10 Buffer solution 11 Judgment tool introduction hole 12 Sealing material 15b Sealing material Opening part 17 Sample introduction hole 18 Separation filter 19 Development layer 19a Start end (anti-hemoglobin antibody sensitized carrier installation site) 19b Anti-hemoglobin antibody immobilization site 20 Judgment window 21 End window 26 Communication member 28 Rod-like body 28a Hole 29 Stopper

─────────────────────────────────────────────────── ─── Continuation of the front page (58) Fields surveyed (Int.Cl. ⁷ , DB name) G01N 33/53 G01N 33/50 G01N 33/543

Claims (2)

(57) [Claims] 1. A stool collection container having a buffer solution container containing a buffer solution, a lid attached to the buffer solution container so as to close the buffer solution container, and a stool collection rod connected to the lid body. And a sealing member provided on the lid body on the side of the buffer solution container surface of the judging tool introducing hole, which can be attached to the lid body. A fecal occult blood determination apparatus provided with a determination tool configured to open the sealing material, wherein the determination tool is inflowed when the sealing material is opened by the determination tool. In order to remove the solid content in the buffer solution in which the stool sample has been dissolved, a separation filter and a stool sample solution in which the solid content has been removed by the separation filter are arranged to be supplied, and Anti-hemoglobin antibody sensitized carrier is installed and anti-hemoglobin And a down antibody immobilized expanded layer, in order to observe the end from the outer surface of the fecal occult blood of presence and determination of the determining device, the side wall of the determination device body observes the development layer partially A fecal occult blood determination device, characterized in that a determination window and an end window are formed so as to obtain. 2. Further, a communication member is attached from the side surface of the lid body to the inside thereof so that the determination tool introducing hole of the lid body can be opened or closed.
The fecal occult blood determining apparatus according to claim 1, wherein