JP3357196B2 - 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 examination apparatus for judging the presence or absence of fecal occult blood, and more particularly to a fecal occult blood judging apparatus utilizing an immunofilter method.

[0002]

2. Description of the Related Art Fecal occult blood develops due to digestive diseases caused by blood contamination in the stool in the digestive tract. In particular, a 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 Japan.

[0003] Currently used fecal occult blood test methods include:
There are roughly two methods. The first method is a conventional chemical occult blood reaction (hereinafter, referred to as “chemical method”), which is a non-specific reaction for detecting a peroxidase-like activity of hemoglobin (hereinafter, referred to as Hb). It is. This method is based on a mechanism in which a chromogen (eg, guaiac or orthotolidine) is oxidized in the presence of a peroxidase-like activity-retaining substance and aqueous hydrogen peroxide to form a color. Therefore, in the present method, the drug and the food containing Hb, which are substances having a peroxidase-like activity, show a positive result, so that dosing and dietary restriction are required.

As an inspection apparatus based on the present chemical method, simple measurement systems have been disclosed, and some of them are widely used. For example, Japanese Patent Publication No. 2-45826,
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, etc. There is disclosed a system in which the state of coloring is checked by dropping hydrogen water. In these systems,
By applying an appropriate amount of a stool sample to a part of the guaiac oil attached to the card type main body and further dropping hydrogen peroxide water on the part on the back side of the application part, whether or not the guaiac oil at the dripping part develops color Is determined. It is advantageous that it can be performed without opening the stool sample application section, can be handled hygienically, and has a simple configuration, but the drawbacks derived from the above measurement principle have not been solved.

The second method, which has been recently developed to solve the above-mentioned disadvantages of the chemical method, 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 as in a chemical method. The determination is performed by a general immunoserological test such as a latex agglutination method or an enzyme-labeled immunoassay, and 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 and mixed on a determination plate, and the determination is made based on the presence or absence of an aggregation image. Although the specificity is high in principle compared to the chemical method, skill is required to judge the agglutination method. In addition, the test system based on the immunization method is provided as a kit including a determination plate, a latex reagent, a stir bar, a stool, a lysing solution, and the like. The system has not been developed.

[0007] The simplification of these immunization methods is a step unique to the immunization method not included in the chemical method, that is, a step of dissolving a stool sample in a buffer solution and the like, and removing undissolved solids in the lysate after dissolution by filtration. The process is performed. That is, as for these operations, a feces collection device capable of relatively quantitative and hygienic handling is disclosed, for example, Japanese Utility Model Laid-Open No. 3-44663, Japanese Utility Model Publication No. 2-3977.
JP, JP-A-1-66071, JP-A-1-8571
In Japanese Patent Application Publication No. 668 and Japanese Utility Model Application Laid-Open No. 64-42454, a collection rod for collecting stool is attached to the lid of a container containing a buffer, and the lid is set in the buffer container after stool collection. Thereby, the stool at the tip of the collection rod is dispersed in the buffer solution. In addition, a filter mechanism is installed in the dropping portion when the dropping portion is dropped onto the determination plate after shaking well, so that insoluble solids are removed. After being dropped on the judgment plate, the operation is carried out according to the above-mentioned conventional latex agglutination method.

[0008] The simplification of the fecal occult blood measurement system by the immunization method seems to be achieved by integrating the above-mentioned steps and the antigen-antibody reaction, but the technology 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 immunochromatography has been established. The biggest problem when using the immunochromatography method for fecal occult blood testing is that the stool sample lysis and filtration steps are difficult to incorporate into the system.

An object of the present invention is to provide a fecal occult blood test apparatus using an immunofilter method, which has a relatively simple configuration, but simplifies the operation throughout the fecal occult blood determination operation. It is an object of the present invention to provide a fecal occult blood determination device that enables even a skilled person to easily and accurately determine the presence or absence of fecal occult blood.

[0011]

Means for Solving the Problems The inventions according to claims 1 and 2 have been made to achieve the above-mentioned objects,
Fecal occult blood determination device comprising a stool collection device having a stool holding portion for holding the collected stool attached to the outer surface thereof, and a buffer solution container into which the stool collection device is inserted from above,
It is characterized by having the following configuration.

According to the first aspect of the present invention, the toilet device includes a communication hole for communicating outside air and the inside of the buffer solution container when the buffer solution container is inserted, and a developing layer installed downward. Part is formed. The spreading layer is provided in the spreading layer setting portion, and the anti-hemoglobin antibody sensitizing carrier is mounted on the spreading layer, and the anti-hemoglobin antibody is immobilized on the spreading layer. In the spreading layer installation part, a separation filter is arranged below the spreading layer. This separation filter is provided for filtering the buffer in which the stool sample is dissolved. Further, a liquid-tight sealing material is disposed below the separation filter. The liquid-tight sealing material is provided to prevent the buffer solution in which the stool sample has been dissolved from entering the developing layer installation portion.

[0013] Further, in the above-mentioned deployment layer installation part, a judgment window and an end window are formed in the feces collection device so that the deployment layer can be observed from the outside. On the other hand, the buffer solution container is formed with a protrusion for breaking the liquid-tight seal material when the feces collection device is inserted.

[0014] According to the second aspect of the present invention, a deployment layer installation portion extending in the longitudinal direction of the feces collection device and having both ends open is formed inside the feces collection device. The spreading layer is attached so as to be movable in the length direction of the spreading layer installation portion. In this spreading layer, an anti-hemoglobin antibody sensitized carrier is provided, and the anti-hemoglobin antibody is immobilized.

According to the second aspect of the present invention, in the spreading layer installation portion, a separation filter is formed integrally with the spreading layer at a lower end of the spreading layer. This separation filter is provided for filtering the buffer in which the stool sample is dissolved. Further, a liquid-tight sealing material is provided below the separation filter in the developing layer installation part to prevent the buffer solution in which the stool sample has been dissolved from entering the developing layer installation part. The liquid-tight sealing material is configured to be broken by the downward movement of the spreading layer.

In addition, a judgment window and an end window are formed in the feces collection device so that the inner developing layer can be observed from the outside. As described above, the inventions according to Claims 1 and 2 include a feces-collecting device and a buffer solution container into which the feces-collecting device is inserted, and determine fecal occult blood by an immunofilter method using the spreading layer. Common in point.

[0017]

When determining fecal occult blood using the fecal occult blood determination device according to the first and second aspects of the present invention, a stool sample is collected in the stool holding section of the stool collection device, and the stool collection device is removed 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 produced. According to the first and second aspects of the present invention, a liquid-tight sealing material is provided to prevent the buffer solution in which the stool sample is dissolved from entering the developing layer installation portion. The dissolved buffer does not enter.

According to the first aspect of the present invention, the liquid-tight sealing material is pierced by the protrusion formed on the buffer solution container by moving the stool. As a result, the buffer in which the stool sample has been dissolved enters the developing layer installation section. The lysate in which the stool sample is dissolved is filtered by a separation filter,
Solids are removed. Next, a buffer solution in which the stool sample is dissolved and solid content is removed is supplied to the developing layer.

On the other hand, in the second aspect of the present invention, after the buffer solution in which the stool sample is dissolved is prepared, the spreading layer is moved in the length direction of the spreading layer installation portion, so that the liquid-tight sealing material is removed. Break through. As a result, the buffer in which the stool sample is dissolved enters the developing layer installation portion. The buffer in which the stool sample is dissolved is filtered by a separation filter to remove solids. The buffer in which the stool sample is dissolved and the solid content is removed is supplied to the developing layer.

According to the first and second aspects of the present invention, the presence or absence of fecal occult blood is determined in the spread layer according to the immunofilter method, as will be apparent from the description of the following embodiments. Furthermore, in the invention according to claims 1 and 2, since the determination window and the end window for confirming the determination and the end of the determination in the deployment layer are formed in the feces collection device, the determination is easily performed from the outside. And the end of the determination can be confirmed.

[0021]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, non-limiting embodiments of the present invention will be described with reference to the drawings. First Embodiment FIG. 1 is a longitudinal sectional view showing a fecal occult blood determination apparatus according to an embodiment of the present invention. The fecal occult blood determination device 1 of the present embodiment includes a feces collection device 2 and a buffer solution container 3.

The toilet device 2 is made of a synthetic resin and has a lid 2a and a substantially columnar toilet device main body 2b having a diameter smaller than that of the lid 2a. The stool holding part 2c is formed in the body part 2b by providing irregularities on the outer peripheral surface on the distal end side. The stool holding part 2c is provided for semi-quantitatively collecting stool.
The shape of is not limited to the shape with irregularities as shown in the figure, but may be configured to have various shapes such as depressions and protrusions as long as stool can be collected semi-quantitatively.
Also, the number of such depressions and projections is not particularly limited.

In the body part 2b, there is provided a deployment layer installation part 2d which is opened downward. Deployment layer installation part 2d
In the present embodiment, is formed as a hole whose lower end is open and extends in the vertical direction. The lower end of the deployment layer installation part 2 d is closed by a liquid-tight seal material 4. The liquid-tight seal material 4 needs to have a strength that is not easily broken in order to collect a stool sample, but the material and the strength that can be easily pierced by the protrusion 5 provided on the bottom inner surface of the buffer solution container 3 It is comprised so that it may have. The liquid-tight sealing material 4 is made of 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 such as a hot-melt adhesive applied to one surface of a laminate thereof. Can be constituted by

The liquid-tight sealing member 4 has a function of preventing entry of stool into the body of the stool and a function of preventing entry of the buffer solution 6 in the buffer solution container when collecting stool. Above the liquid-tight seal member 4, a separation filter 7 is disposed. The separation filter 7 is provided for removing insoluble solids in the stool sample solution. Therefore, the separation filter 7 is attached to the lower end side of the developing layer installation part 2d such that the outer peripheral surface is in close contact with the inner peripheral surface of the developing layer installation part 2d. Since the separation filter 7 has a filtering function as described above, it can be made of a known separation membrane or filter material such as filter paper or nitrocellulose. Further, the separation filter 7 may be made of a cellulose-based or synthetic polymer-based porous material.

The spreading layer 8 is disposed above the separation filter 7. The spreading layer 8 is arranged such that the start end 8 a thereof is above the separation filter 7. Therefore,
The stool sample solution from which solids have been removed by the separation filter 7 penetrates the starting end 8a.

On the other hand, a judgment window 2e and an end window 2f are formed in the feces collection device main body 2b so that the internal development layer 8 can be observed from the outside. In FIG.
The positions where the determination window 2e and the end window 2f are provided are schematically indicated by circles. The determination window 2e is located above the start end 8a and is provided for observing the determination result of fecal occult blood. The end window 2f is arranged above the determination window 2e, and is provided for visually observing the end of the immunochromatography.

Preferably, the judgment window 2e and the end window 2f are liquid-tightly closed with a transparent material, so that liquid leakage can be prevented. As such a transparent material, a transparent synthetic polymer material such as polyethylene and polyvinyl chloride can be used.

The developing layer 8 is provided to carry out a known immune filter method, and is made of a porous material. That is, a carrier sensitized with an antibody to the test substance (hereinafter abbreviated as a first antibody) is provided at the starting end 8a. Further, a second antibody that recognizes an epitope different from that of the first antibody is immobilized at a position separated by a certain distance from the installation site of the first antibody-sensitized carrier. Start end 8a of spread layer
When the test substance-containing liquid sample is developed from the above, the sample moves on the developing layer 8 and the test substance causes an antigen-antibody reaction with the first antibody.

The test substance-first antibody-sensitized carrier complex further moves through the spreading layer and reaches the second antibody-immobilized site.
As a result, the test substance-the first antibody-sensitized carrier complex is trapped in the second antibody-immobilized site by the antigen-antibody reaction of the test substance with the second antibody. Therefore, if the carrier has a color tone having a clear contrast with the spreading layer 8,
The presence of the carrier, that is, the presence of the test substance can be easily confirmed visually.

In this embodiment, the test substance is human hemoglobin, which is an index for determining fecal occult blood, and the test substance-containing liquid sample is the stool lysate described above. Examples of the material forming the spreading layer 8 include a conventional membrane such as a cellulose-based material such as nitrocellulose and cellulose acetate, and a synthetic polymer-based material such as nylon, fluoroethylene resin, polypropylene, and polyvinyl chloride resin. Various materials used as filter materials can be used.

The developing layer 8 must 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 spreading layer 8 is black, and to use a colored carrier when the spreading layer 8 is white. Also, the most preferred as the carrier is latex particles, but since the latex particles are usually white, when the background is white, for example,
Styrene, latex particles obtained by emulsion polymerization of vinyl toluene, etc., in a reaction medium containing water and an organic solvent compatible with water, contact with a poorly water-soluble colorant dissolved in the reaction medium. A latex particle obtained by emulsion polymerization and having an anionic functional group, for example, a latex particle made of a copolymer containing a monomer having an anionic functional group such as (meth) acrylic acid. In the medium, it is preferable to use colored latex particles obtained by, for example, a method of coloring by contacting with a colorant which is an amphoteric electrolyte dissolved in the reaction medium.

The anti-human Hb antibody used in the present invention (first
Antibody) can be obtained by purifying an antiserum obtained by immunizing rabbits, sheep, goats, horses, guinea pigs or the like with human Hb by affinity chromatography or the like. Monoclonal antibodies can also be produced 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 method of sensitizing an anti-human Hb antibody to a carrier can be performed by a known method such as a separation adsorption method or a chemical bonding method. For example, a buffer solution of an 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 surface of the latex by heating the solution to the temperature. 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 ”. ) May be added.

The first antibody-sensitized carrier obtained is placed on the spreading layer 8 by, for example, adding a 0.01 to 10% by weight dispersion of the antibody-sensitized carrier to a predetermined amount of 0.05 to 1 ml. This can be done by dropping in place and drying at room temperature for at least 12 hours.

Further, a second antibody is immobilized on the development layer 8 at a site observed by the judgment window 2e.
As the second antibody, an anti-human hemoglobin antibody having a different epitope from the first antibody can be used. As the immobilization method, 1 to 5 mg / ml of the second antibody 0.1 to 10 μm
1 is dropped at a predetermined position and left at room temperature for 12 hours or more,
Further, as an example, a method in which BSA or the like is dropped and dried at the same position as needed is exemplified.

The buffer 6 is preferably a neutral salt solution such as an ammonia buffer, a glycine buffer, a phosphate buffer, and a Tris buffer, and particularly preferably, a pH of 6.5 to 8.0. 5 ranges of the above buffers. The amount of the buffer depends on the amount of the stool sample to be collected, but is preferably about 0.5 to 10 ml.

Returning to FIG. 1, the feces collection device 2 includes
A communication hole 2g is formed for connecting the inside of the buffer solution container 3 with the outside air in a state where is inserted into the buffer solution container 3. The communication hole 2g is provided as an air vent for facilitating the operation of inserting the stool 2 into the buffer solution container 3 and the operation of lifting the stool 2 for starting the reaction.

Further, in the fecal occult blood determination device 1 of this embodiment,
A hermetic plug 9 for closing the communication hole 2g is fixed. The hermetic plug 9 is provided to open and close the communication hole 2g, and can be made of, for example, a synthetic resin such as polyethylene or vinyl chloride resin.

In the present embodiment, the lid 2 of the
a and the body part 2b are integrally formed of a substantially rod-shaped synthetic resin, but the lid 2a and the body part 2b are separately formed, and an adhesive or the like is used. May be joined together. Further, the stool collection device 2 can be made of another appropriate material such as a metal.

On the other hand, the buffer solution
Is stored. An O-ring 10 is attached to the buffer solution container 3 in order to enhance the sealing property with the feces collection device 2 when the feces collection device 2 is inserted. In addition, a protruding portion 5 for piercing the liquid-tight seal member 4 at the tip of the feces collection instrument 2 is provided at the center of the bottom surface of the buffer solution container 3. The shape of the protruding portion 5 is not limited to the shape shown in the drawing as long as the protruding portion 5 can penetrate the liquid-tight seal member 4, and may be formed in an appropriate shape. A plurality of protruding portions 5 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 configuring a fecal occult blood determination device. In addition, buffer solution container 3
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 a metal.

Next, a method of using the fecal occult blood judging device shown in FIG. 1 will be described with reference to FIG. 2 and FIG. First, FIG.
Of the fecal occult blood determination device 1 assembled as shown in FIG. Thereafter, the stool collection device 2 is pulled out of the buffer solution container 3.

In the initial assembled state shown in FIG. 1, the liquid-tight seal member 4 is arranged at a position separated by a predetermined distance from the tip of the projection 5. A stopper may be provided on the toilet device 2 or the buffer solution container 3 side so that the liquid-tight seal member 4 is not pierced by the protrusion 5 before use. That is, a stopper that regulates the insertion depth of the feces collection device 2 so that the liquid-tight seal member 4 provided on the side of the feces collection device 2 does not contact the tip of the protruding portion 5 is provided on the outer surface of the feces collection device 2 and / or Alternatively, it may be provided at the upper end of the buffer solution container 3. However, when the determination operation described later is started, the liquid-tight seal member 4 needs to be pierced by the protruding portion 5. Therefore, the stopper is detachable, or the stopper of the stopper when the stool 2 is manually inserted. It needs to be configured so that the function can be released.

Next, as shown in FIG. 2 (a), the stool A body 2b of the stool collection device 2 is pierced into the stool A to collect stool. In some cases, after piercing the stool, the stool collection device main body 2b may be wiped off the stool, and the excess stool adhering to the stool holding portion 2c may be wiped off. Thereafter, the stool collection device 2 is inserted again into the buffer solution container 3 (FIG. 2).
(B)). In this state, the buffer solution container 3 is turned,
In some cases, the fecal sample is dissolved in the buffer solution 6 by turning over the entire fecal occult blood determination device 1.

Next, as shown in FIG. 2C, the toilet device 2 is moved downward, and the liquid-tight sealing member 4 (see FIG. 1) is pierced by the projection 5. Thereafter, the stool collection device 2 is slightly lifted, and the stool sample solution is introduced into the developing layer installation section 2d. The introduction of the stool sample solution is performed by capillary action because the separation filter 7 is made of a porous material or the above-described filter material.

Next, the stool collection device 2 is pulled up, and the determination by immunochromatography is started (see FIG. 3A). That is, the stool sample solution enters the developing layer installation part 2 d, and the solid content is removed in the separation filter 7.
The stool sample solution from which solids have been removed penetrates the developing layer 8 from the starting end 8a and diffuses on the developing layer 8. The stool sample solution moves upward on the developing layer 8 together with the first antibody-sensitized carrier. At this time, if 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-adsorbed carrier causes an antigen-antibody reaction with the second antibody at the site where the second antibody is located, as described above. Be trapped.

On the other hand, when human hemoglobin was not contained in the stool solution, human hemoglobin-primary
The antibody-sensitized carrier complex is not trapped by the second antibody, and moves to the portion of the spreading layer 8 where the end window 2f is located.
Therefore, by observing from the judgment window 2e, the color tone of the carrier is observed (positive) when human hemoglobin is contained in the stool lysate, and is not observed when human hemoglobin is not contained (negative: developing layer) 8 with the color of the ground).

The shape and size of the judgment window 2e are not limited as long as the judgment window 2e is arranged at a position where the above judgment is clearly observed. The end of the determination is performed by observing the developing layer 8 from the end window 2f. At the stage where the determination is completed, the hermetic plug 9 is attached to the communication hole 2g to prevent leakage of the stool solution, and the measurement is ended ( FIG. 3 (b)).

In the above embodiment, the lid 2a of the stool 2 is formed of a columnar member having a diameter larger than that of the stool 2b, as shown in FIGS. 4 and 5. May be deformed.

For example, in the structure shown in FIG. 4, a hollow portion 2h is formed in the lid 2a. This hollow part 2h
Is communicated with the deployment layer installation part 2d. The elastic film 2i is attached so as to cover the space below the hollow portion 2h. Above the lid 2a, a lid 2j is formed integrally. In this structure, the stool solution is applied to the developing layer 8.
The stool dissolving solution can be introduced into the developing layer installation part 2d by utilizing the elasticity of the elastic film 2i without utilizing the capillary phenomenon.

In the structure shown in FIG. 5, a hollow portion 2h is formed in the lid 2a, and a hollow elastic sphere 2k is mounted in the hollow portion 2h so as to communicate with the developing layer installation portion 2d. I have. After squeezing the elastic sphere 2k, the stool sample solution can be sucked and introduced into the developing layer installation part 2d by returning to the original shape.

As a material for forming the elastic film 2i and the elastic sphere 2k, an appropriate material such as synthetic rubber, natural rubber, or synthetic resin having elasticity can be used.

Second Embodiment FIG. 6 is a longitudinal sectional view showing a fecal occult blood test apparatus according to a second embodiment of the present invention.

The fecal occult blood judging device 21 comprises:
A buffer solution container 23. The stool collection device 22 includes a lid 22.
a and a feces collection instrument main body 22b. Irregularities are formed on the outer peripheral surface near the lower end of the body part 22b, and the stool holding part 24 is constituted by the irregularities. The shape of the stool holding part 24 is not limited to the one shown in the drawing, and can be formed into an appropriate shape as long as stool can be collected semi-quantitatively, such as a dent or a projection. It is not limited.

In the feces collection device 22, a deployment layer installation part 22c extending in the length direction of the feces collection device 22 and having both open ends is formed. In this embodiment, the deployment layer installation portion 22c is formed as a through hole extending in the up-down direction.

The developing layer setting section 22c includes the developing layer setting section 2
The development layer 25 is attached so as to be movable in the length direction of 2c. The development layer 25 has a flange portion 25a at the upper end. The flange portion 25a is provided to prevent the spreading layer 25 from dropping downward from the spreading layer installation portion 22c.

A liquid-tight seal member 26 is attached to the lower end of the developing layer installation part 22c. The liquid-tight sealing material 26
It has such a strength that it does not break when collecting the stool, and when the spreading layer 25 is moved downward as described later,
It is configured to be able to break through by the lower end of the. The liquid-tight sealing member 26 can be formed of the same material as the liquid-tight sealing member 4 shown in the first embodiment, and has the same function as the liquid-tight sealing member 4 used in the first embodiment. Fulfill.

Above the liquid-tight sealing member 26, a separation filter 27 is provided integrally with the developing layer 25. The separation filter 27 is provided to remove insoluble solids in the stool sample solution. The separation filter 27 can be made of, for example, a known separation membrane or filter material such as filter paper or nitrocellulose, or may be made of a cellulose-based or synthetic polymer-based porous material.

The lower end portion 27a provided with the separation filter 27 has a pointed tip as shown in the figure. This is to make it easier to break through the liquid-tight seal material 26 at the tip 27a as described later.

In the fecal occult blood determination apparatus of this embodiment, the buffer solution 29 stored in the buffer solution container 23 enters the developing layer installation portion 22c when the liquid-tight seal material 26 is pierced. Is supplied from the sample introduction unit 28 to the separation filter 27. In the separation filter 27, the solid content is removed, and the buffer solution in which the stool sample is dissolved permeates into the starting end 25a of the developing layer 25.

Above the sample introduction part 28, a judgment window is provided in the body part 22c at the position of the circle indicated by the reference numeral 30 in FIG. This determination window is used for the development layer 25
Is provided for observing the determination result based on the antigen-antibody reaction in the above.

Further, an end window is provided above the judgment window at the position indicated by a circle 31 in the body part 22b for feces collection. The end window is provided for visually confirming the end of the chromatography from the outside.

Note that the judgment window and the end window are closed by a transparent film or the like. As such a transparent film, a synthetic resin material such as polyethylene or polyvinyl chloride can be used.

The development layer 25 has the same configuration as the development layer 8 used in the first embodiment. Therefore, the description of the development layer 25 is omitted by using the description of the development layer 8 described above.

The buffer 29 is preferably a neutral salt group such as an ammonia buffer, a glycine buffer, a phosphate buffer, or a Tris buffer, and particularly preferably has a pH of 6.5 to 6.5. The above buffers in the range of 8.5 are mentioned. The amount of the buffer depends on the amount of the stool sample to be collected, but is preferably about 0.5 to 10 ml.

In the fecal occult blood determination apparatus 21 of this embodiment, the O-ring 32 is attached so as to be in contact with the inner peripheral surface of the developing layer installation part 22c. The O-ring 32 is provided to enhance the sealing property between the developing layer 25 and the inner peripheral surface of the developing layer installation part 22c, that is, to prevent leakage of the stool sample solution.

The feces collection device 22 and the buffer solution container 23 are made of a synthetic resin material, but may be made of other materials such as. The internal volume of the buffer solution container 23 is
Although not particularly limited, it is usually about 1 to 10 ml.

Further, an excess stool removal ring 33 for removing an excess stool sample attached to the stool collection device 22 is attached to the upper part of the buffer solution container 23. In the present embodiment, the lid 22a of the stool collection device 22 and the buffer solution container 23
The two are connected by screwing the lower inner peripheral surface of the lid 22a to the outer peripheral surface near the upper end of the buffer solution container 23, but as long as the inside can be sealed, the buffer solution container 23 and the lid The joint portion with the body 22a may be connected by an appropriate liquid-tight coupling mechanism.

Next, a method of using the second embodiment will be described. First, as shown in FIG. 6, a fecal occult blood determination device 21 that has been assembled in advance is prepared. Next, the feces collection device 22 is pulled out from the buffer solution container 23. In this case, the development layer 25
A stopper may be provided on the developing layer 25 or the stool 22 so that the developing layer 25 does not move downward from the illustrated position so as not to pierce the liquid-tight seal material 26.

Next, as shown in FIG. 7A, the tip of the stool A is pierced into the stool A, and then the stool A is withdrawn to collect a stool sample. After collecting the stool sample, the stool collection device 22 is inserted into the buffer solution container 23 (FIG. 7).
(B)). In this state, the whole swirls or falls and mixes,
The stool sample is dissolved in the buffer solution 29.

Next, as shown in FIG.
5 is moved downward, the liquid-tight sealing material 26 is broken through at the tip 27a, and the stool sample solution is introduced into the developing layer installation part 22c.

This stool sample solution is introduced into the separation filter 27 from the stool sample introduction section 28 by capillary action. In the separation filter 27, insoluble solids in the stool sample solution are removed. Then, the deployment layer 25 is pulled up,
The stool sample solution from which solids have been removed is developed in the developing layer 25. In the developing layer 25, the presence or absence of fecal occult blood is determined in the same manner as the determination in the developing layer 8 described in the first embodiment. The judgment result can be observed from the judgment window 30, and the end of the judgment can be observed through the end window 31.

In the second embodiment, the spreading layer 25 is press-fitted into the spreading layer setting portion 22c of the feces collection device 22, but as shown in FIG. 9, a thread 25c is formed on the outer peripheral surface of the spreading layer 25. Further, a female screw that meshes with the thread may be formed on the inner peripheral surface of the deployment layer installation part 22c, so that the development layer 25 is screwed into the development layer installation part 22c to move the development layer 25.

Further, as shown in FIG.
2, a leaf spring 34 is attached to the lower end of the body part 22b, and an elastic layer 35a is formed on the inner surface at the other end of the leaf spring 34.
May be fixed. In this case, the leaf spring 34 is always attached to the cover 35b so that the deployment layer installation portion 22c is closed by the elastic body 35a.
Is energizing. Therefore, at the time of use, the spreading layer 25 is moved downward, and against the elasticity of the leaf spring 34,
The lid 35b may be moved to the position shown in FIG. 10, whereby the stool sample solution may be introduced into the developing layer installation part 22c.

FIG. 10 shows that the developing layer 25 is moved downward against the urging force of the leaf spring 34 and is bent to a position where the leaf spring 34 cannot return to the original shape.
5 shows the state where it was pulled up.

[0076]

As described above, according to the first and second aspects of the present invention, after a stool sample is collected in the stool holding section of the stool collection instrument, the stool collection instrument is inserted into the buffer solution container. In the first aspect of the present invention, the stool sample dissolving solution can be introduced into the developing layer installation section by moving the stool collection instrument, and in the second aspect of the present invention by moving the developing layer. Further, the introduced stool sample solution is subjected to removal of solids by the separation filter and supplied to the developing layer, where the presence or absence of fecal occult blood is determined based on immunochromatography. Moreover, the presence or absence of fecal occult blood can be easily grasped by observing from outside through the determination window.

Thus, according to the first and second aspects of the present invention, the presence or absence of fecal occult blood can be reliably determined by an extremely simple operation without requiring much skill. Further, in the inventions according to claims 1 and 2, a developing layer constituting immunochromatography is provided on the stool collection instrument side as described above, and the system is constituted only by the stool collection instrument and the buffer solution container. Therefore, the structure of the fecal occult blood test apparatus can be simplified, and the size of the fecal occult blood test apparatus can be reduced.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a fecal occult blood determination device according to a first embodiment.

FIGS. 2 (a) to 2 (c) are schematic diagrams illustrating steps from the collection of a stool sample in the fecal occult blood test apparatus of the first embodiment to the preparation of a stool sample solution. Sectional view.

FIGS. 3A and 3B are schematic cross-sectional views illustrating a process of determining fecal occult blood using the fecal occult blood determination device according to the first embodiment.

FIG. 4 is a partially cutaway sectional view showing an example in which a structure for introducing a stool sample solution is provided in a lid body as a first modified example.

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

FIG. 6 is a longitudinal sectional view showing a fecal occult blood determination device according to a second embodiment.

FIGS. 7 (a) and 7 (b) are schematic diagrams illustrating steps from collecting a stool sample using the fecal occult blood determination device of the second embodiment to preparing a stool sample solution. Sectional view.

FIGS. 8A and 8B are schematic cross-sectional views illustrating an operation of making a determination using the fecal occult blood determination device of the second embodiment.

FIG. 9 is a partially cutaway longitudinal sectional view for explaining a modified example of the structure for connecting the developing layer to the feces collection device in the fecal occult blood determination device of the second embodiment.

FIG. 10 is a partially cutaway sectional view showing an example in which the structure of the stool sample dissolving solution introduction section of the second fecal occult blood determination device is modified.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Fecal occult blood judging device 2 ... Lid 2c ... Retention part 2d ... Deployment layer installation part 2e ... Judgment window 2f ... End window 2g ... Communication hole 3 ... Buffer solution container 4 ... Liquid-tight sealing material 5 ... Projection part 6 ... Buffer Liquid 7 ... Separation filter 8 ... Spreading layer 21 ... Fecal occult blood determination device 22 ... Stool collection device 23 ... Buffer solution container 24 ... Stool holding unit 25 ... Spreading layer 26 ... Liquid tight seal material 27 ... Separation filter 29 ... Judgment window 30 ... End window

Continuation of the front page (58) Field surveyed (Int.Cl. ⁷ , DB name) G01N 33/50 G01N 33/48 G01N 33/53 G01N 33/543 G01N 33/72

Claims (2)

(57) [Claims] 1. A fecal occult blood judging device comprising: a stool collection device having a stool holding portion for holding a collected stool by attaching to an outer surface thereof; and a buffer solution container into which the stool collection device is inserted from above. A communication hole for communicating the outside air and the inside of the buffer solution container when the buffer solution container is inserted, and a deployment layer installation portion opened downward; A developing layer on which the anti-hemoglobin antibody-immobilized carrier is disposed, and the anti-hemoglobin antibody is immobilized, and the developing layer is disposed below the developing layer in the developing layer setting section. And a separation filter for filtering a buffer solution in which the stool sample is dissolved, and disposed below the separation filter in the developing layer installation portion, to the developing layer installation portion of the buffer solution in which the stool sample is dissolved. To prevent ingress of water A sealing material, further comprising: a judgment window and an end window formed on the feces sampling device so as to enable the developing layer to be observed from the outside; and the buffer solution container includes the feces sampling device. The feces occult blood determination device, wherein a protrusion for breaking the liquid-tight seal material is formed by moving the feces. 2. A fecal occult blood judging device comprising: a stool collection device having a stool holding portion for holding a collected stool attached to an outer surface thereof; and a buffer solution container into which the stool collection device is inserted from above. Inside the feces collection device, there is formed a deployment layer installation portion extending in the length direction of the feces collection device and having both ends open, and is attached movably in the length direction of the deployment layer installation portion. And a developing layer on which an anti-hemoglobin antibody sensitized carrier is installed, and an anti-hemoglobin antibody is immobilized, and at the developing layer installation portion, formed at the lower end of the developing layer, and a stool sample And a separation filter for filtering the buffer in which the stool sample has been dissolved, wherein the stool sample is disposed below the separation filter, and the stool sample enters the development layer in the buffer. Provided to prevent And further comprising a liquid-tight seal material configured to be broken by the downward movement of the spreading layer, in order to enable the inside of the spreading layer to be externally observed in the stool. Fecal occult blood determination device, wherein a determination window and an end window are formed.