JPH0734370U - Fecal occult blood tester - Google Patents

Abstract

(57) [Summary] [Object] To provide a device capable of simply performing operations from the collection of a stool sample to the immunological determination of the presence or absence of fecal occult blood without requiring skill. [Structure] A stool collection tool 2 in which the stool collection rod 6 is fixed to the inner surface of a lid 5 so that the stool collection rod 6 can be moved downward by pressing the top surface 5a, and a buffer solution 8 is stored. The buffer solution container 3 configured such that the seal material 7 is pierced by the dropping of the stool collection rod 6, the separation filters 11 and 12 provided in the flow path 10 below the seal material 7, and the buffer solution. A fecal occult blood test apparatus 1 that is detachably attached to the bottom of a container 3 and includes a measurement container 4 to which an anti-human hemoglobin antibody sensitizing reagent 13 is fixed on the inner bottom surface.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to an apparatus for inspecting fecal occult blood, and more particularly to a simple apparatus for inspecting occult blood in which digestive system abnormality can be easily screened by anyone.

[0002]

[Prior art]

 Today, besides blood, stool and urine are often used as clinical test samples. Among them, the detection of fecal occult blood is extremely effective for early detection of digestive system diseases such as cancer and ulcer.

The methods for detecting fecal occult blood can be roughly classified into a chemical fecal occult blood reaction method and an immunological fecal occult blood reaction method. The chemical fecal occult blood reaction method utilizes the color development of a chromogen based on the peroxidase activity of hemoglobin contained in hemoglobin, and has a characteristic that it has high sensitivity and can detect even a small amount of hemoglobin. However, this reaction has no specificity for human hemoglobin and also reacts with animal hemoglobin, so that there is a drawback that the subject needs a dietary restriction prior to the test.

On the other hand, the immunological fecal occult blood reaction method utilizes an antigen-antibody reaction using an anti-human hemoglobin antibody. The immunological fecal occult blood reaction method is more specific than the chemical fecal occult blood reaction method and does not require the above-mentioned dietary restrictions.

In the immunological fecal occult blood reaction method, the judgment is usually performed by an immunoserologic test method, and the method most used today is the latex agglutination method. The latex agglutination method is a judgment method for diagnosing an agglutination image formed by mixing a stool solution and a latex reagent on a judgment plate. The following operations are necessary to detect fecal occult blood by the latex agglutination method based on the immunological principle.

First, an appropriate amount of stool is collected, and the collected stool is dissolved in a liquid such as physiological saline to prepare a stool sample solution. In the stool sample solution, undigested solid content in stool remains, so remove it using a filter or the like. Various proposals have been made so far regarding these operations.

For example, a structure for quantitatively collecting feces is disclosed in Japanese Utility Model Publication No. 61-102941 and Japanese Utility Model Publication No. 1-158964. Further, a device for obtaining a stool sample solution from which solids have been removed is disclosed in Japanese Utility Model Publication No. 2-21557, Japanese Utility Model Publication No. 2-14 0468, Japanese Utility Model Publication No. 2-13977.

As described above, various structures have been proposed for the steps until obtaining the stool sample solution. However, at present, there is no test system capable of mixing fecal sample lysate and anti-human hemoglobin antibody sensitizing reagent and mixing fecal occult blood.

[0009]

[Problems to be solved by the device]

 Among the above-mentioned fecal occult blood detection methods, the method using the chemical fecal occult blood reaction method has established a simple test device, but since it uses a non-specific reaction in principle, It is easily affected. Therefore, as described above, there is a drawback that dietary restrictions are required.

On the other hand, those using the immunological fecal occult blood reaction method have high specificity in principle and high sensitivity in detecting fecal occult blood. However, there are drawbacks that it requires skill to judge the agglutination reaction and the system configuration is complicated. That is, although the conventional structure described above simplifies the operation until obtaining the stool sample lysate, the subsequent process, that is, the stool sample lysate obtained and the anti-human hemoglobin antibody sensitizing reagent It was not possible to mix and even detect fecal occult blood. Therefore, fecal occult blood could not be accurately detected unless the judgment plate, the reagent, and the stirring rod were prepared and the judgment was made by a skilled worker.

The object of the present invention is to solve the above-mentioned drawbacks of the related art, to use an immunological fecal occult blood reaction method, and to easily perform stool sample collection to fecal occult blood detection by anyone. An object of the present invention is to provide a fecal occult blood test apparatus capable of performing the above.

[0012]

[Means for Solving the Problems]

 The present invention provides a stool collection tool having a lid and a stool collecting rod for collecting a stool sample, which is fixed to the inner surface of the lid so as to be movable in the length direction, and a stool collection tool. , Which is detachably attached and has a flow path leading to the outside in the lower part, and a buffer solution for dissolving the stool sample, which is housed in the buffer solution container. To remove the solids in the stool sample solution, which is provided on the downstream side of the sealing material in the flow channel and the sealing material that is pierced by moving the stool collection rod so as to block the channel. The separation filter, the measurement container that is removably attached to the buffer solution container and communicates with the flow path in the attached state, and the anti-human hemoglobin antibody sensitizing reagent that is fixed in the measurement container. It is a fecal occult blood test device.

[0013]

[Action]

 In the fecal occult blood test apparatus of the present invention, a stool sample can be collected from feces with a stool collection device. Further, this stool collection device is detachable from the buffer solution container so that it can be attached to the buffer solution container after collecting the stool sample.

In addition, the buffer solution is stored in the buffer solution container, and by attaching the stool collection tool to the buffer solution container, the sample attached to the stool collection rod fixed to the inner surface of the lid body is buffered. It is dissolved in the liquid.

Further, the stool sampling rod is moved to pierce the sealing material, so that the obtained stool sample solution flows into the flow channel, and the solid content is removed by the separation filter in the flow channel.

The stool sample solution that has passed through the separation filter is dripped into the measuring container attached to the buffer container, and the anti-human hemoglobin antibody sensitizing reagent is fixed in the measuring container. The presence or absence of fecal occult blood can be visually determined in the body.

As described above, by using the fecal occult blood test apparatus of the present invention, all the operations from the collection of a stool sample from feces to the measurement of fecal occult blood by an immunological method can be easily performed. You can

[0018]

【Example】

 Hereinafter, the present invention will be clarified by describing an embodiment with reference to the drawings.

FIG. 1 is a vertical sectional view showing a fecal occult blood test apparatus according to an embodiment of the present invention, and FIG. 2 is a perspective view showing its appearance. The fecal occult blood test apparatus 1 of the present embodiment includes a fecal sampling device 2, a buffer container 3 and a measurement container 4. The details of the configuration of these members will be described.

The stool collection device 2 has a lid 5 and a stool collection device 6 fixed to the inner surface of the top surface of the lid 5. The lid 5 is composed of a substantially cylindrical member having a top surface 5a, and an internal thread 5b is formed on the inner peripheral surface thereof. The female screw 5b is formed so as to be screwed with a screw thread 3a formed on the outer peripheral surface of the upper portion of the buffer solution container 3 described later. Therefore, the toilet device 2 can be detachably attached to the buffer solution container 3.

The top surface 5a of the lid 5 is formed to be quite thin as shown in the figure, so that the stool collecting stick 6 fixed to the inner surface can be moved downward by pressing the top surface 5a with a finger. Is configured. That is, the stool collection stick 6 is fixed to the inner surface of the top surface 5a so as to be movable along the length direction.

The lid 5 needs to have a thickness and a material that allow the top surface 5a to bend downward when pressed by a finger. In this embodiment, the lid 5 is made of synthetic resin. There is. However, as long as the top surface 5a can be bent downward when the top surface 5a is pressed with a finger, the lid body 5 may be made of another material such as metal.

Although the stool collection rod 6 is entirely made of a substantially rod-shaped synthetic resin material, it is provided at a mounting portion 6a having a relatively large diameter, a shaft portion 6b, and a tip of the shaft portion 6b. It has a puncture portion 6c having a sharp tip. At the mounting portion 6a, it is fixed to the inner surface of the top surface 5a of the lid body 5 by adhesion or the like. However, the stool collecting rod 6 may be formed integrally with the lid body 5.

The puncture portion 6c provided at the tip of the stool collection stick 6 has a sharp shape with a pointed tip as shown in the figure. This is because it is easy to break through the sealing material 7 described later.

Further, a plurality of irregularities 6d are formed in the middle of the puncture portion 6c, and it is possible to collect a predetermined amount of stool sample from feces by the irregularities 6d. The stool collecting rod 6 may also be made of another material such as metal other than synthetic resin.

The buffer solution container 3 has a substantially cylindrical shape, and the thread 3a described above is formed in the vicinity of the upper end of the outer peripheral surface thereof, whereby the stool collection device 2 can be attached. . A buffer solution 8 is stored in the buffer solution container 3. The buffer solution 8 is stored to dissolve the stool sample. As a buffer solution that can be used, a neutral salt solution such as an ammonia buffer solution, a glycine buffer solution, a phosphate buffer solution, and a Tris buffer solution is used, and the pH value is in the range of 6.5 to 8.5. Is preferred.

The buffer solution container 3 is made of synthetic resin such as polyethylene, polypropylene or vinyl chloride resin, but may be made of other material such as metal. Moreover, the capacity of the portion of the buffer solution container 3 in which the buffer solution 8 is stored is not particularly limited, but is preferably about 1 to 10 ml.

An opening is formed in the upper portion of the buffer solution container 3, and a surplus feces removing lid 9 is fixed above and below so as to cover the opening. The surplus feces removal lid 9 may be integrally formed with the buffer solution container 3 by using the same material as the synthetic resin forming the buffer solution container.

The surplus stool removal lid 9 has a shape that projects downward in the center, and has a through hole 9a for removing surplus stool in the center. The diameter of the through hole 9a is set such that when the stool collection rod 6 from which a stool sample is collected passes through the through hole 9a, excess stools other than the stool collected in the recesses of the irregularities 6d are removed from the upper surface of the excess stool removal lid 9. It is chosen to be removable on the side.

A flow path 10 is formed below the portion where the buffer solution container 8 is stored. In this embodiment, the flow channel 10 is formed on the bottom surface of the portion in which the buffer solution container 8 is stored, and the sealing material 7 is attached so as to close the flow channel 10. The sealing material 7 is provided so that the buffer solution 8 does not always flow out to the flow path 10 side, and is pierced by the puncture portion 6c at the tip of the stool collecting rod 6 when the stool collecting rod 6 is lowered. It is formed with the material and thickness. As such a sealing material 7, for example, hot melt heat sealing can be used.

Below the flow path 10, first and second separation filters 11 and 12 are attached. The first separation filter 11 is provided to remove insoluble solids in the stool sample solution, and is composed of, for example, a known separation paper such as filter paper or nitrocellulose, or a filter material.

The second separation filter 12 is also provided for removing solids in the fecal sample solution, and is made of a cellulose-based or synthetic polymer-based porous material. The average pore diameter of this porous material is preferably about 0.1 to 2 μm.

The measurement container 4 is composed of a bottomed cylindrical synthetic resin container having an opening at the top. An anti-human hemoglobin antibody sensitizing reagent 13 is fixed to the bottom surface of the measurement container 4.

A female screw 4 a is formed on the inner peripheral surface near the upper end of the measurement container 4, and the female screw 4 a is screwed into a screw thread 3 b formed on the outer peripheral surface near the lower end of the buffer container 3. Is configured to get. Therefore, the measuring container 4 can be attached to the lower side of the buffer solution container 3 as shown in the drawing, and can be removed from the buffer solution container 3 by unthreading the screw thread 3b and the female screw 4a. .

The anti-human hemoglobin antibody sensitizing reagent 13 is obtained by sensitizing an antibody with an anti-human hemoglobin antibody. As the carrier for sensitizing the antibody, gold colloid particles and silica gel particles can be used, but polystyrene latex particles are preferably used. The carrier can be sensitized with an anti-human hemoglobin antibody by a known physical adsorption method, chemical adsorption method, or the like.

For example, the anti-human hemoglobin antibody can be physically adsorbed on the latex surface by mixing a 1 wt% latex with a buffer solution of the anti-human hemoglobin antibody and stirring at 37 ° C. for 1 to 2 hours. In addition, by using a latex having a carboxyl group on the surface and performing the same operation, the anti-human hemoglobin antibody can be chemically adsorbed to the latex via a covalent bond.

As a method for immobilizing the anti-human hemoglobin antibody sensitizing reagent 13 on the measurement container 4, the anti-human hemoglobin antibody-sensitizing reagent is immobilized on a determination plate (not shown) in advance, A method of arranging the determination plate on the bottom surface of the measurement container 4 or a method of directly immobilizing the anti-human hemoglobin antibody sensitizing reagent on the bottom surface of the measurement container 4 can be used.

Immobilization of the reagent on the determination plate or the bottom surface of the measurement container 4 can be performed by dropping the reagent on these members and drying at room temperature for 12 to 24 hours. In addition, upon immobilization, if a polysaccharide such as cellulose, hemicellulose, pectin, etc. is mixed with a reagent and dried, a film can be formed and the scattering of the reagent can be prevented, so more complete immobilization is possible.

With respect to the amount of the anti-human hemoglobin antibody sensitizing reagent, an appropriate amount of the anti-human hemoglobin antibody sensitizing reagent of a 1% by weight solution is about 20 to 50 μl in the fecal occult blood test apparatus of this example.

In the fecal occult blood test apparatus of this embodiment, first, the lid 2 is removed from the buffer solution container 3, the tip of the fecal sampling rod 6 is pierced into the feces, and a fecal sample is collected. After that, by attaching the stool collection tool 2 to the buffer solution container 3 as shown in the drawing, excess stool can be removed when passing through the through hole 9a of the excess stool removal lid 9, and the stool sample can be semi-quantitatively sampled. It can be immersed in the buffer solution 8. The stool sample can be dissolved in the buffer container 8 by inverting the buffer container 3 in that state to obtain a stool sample solution. Further, by pressing the top surface 5a of the lid 5 downward from the state shown in the drawing, the sealing material 7 is pierced by the stool sampling rod 6b, and the stool sample solution is caused to flow down into the flow channel 11. The insoluble solid content in the stool sample solution is removed by the first and second separation filters 11 and 12, and the stool sample solution in which the solid content is removed is dropped into the measurement container 4. Then, the dropped stool sample solution is mixed with the reagent on the anti-human hemoglobin antibody sensitizing reagent 13. Therefore, the presence or absence of fecal occult blood can be measured by removing the measurement container 4 from the buffer solution container 3 and observing the inner bottom of the measurement container 4.

FIG. 3 is a sectional view illustrating a fecal occult blood test apparatus according to a second embodiment of the present invention. Since the fecal occult blood test apparatus 21 of the second embodiment is configured substantially the same as the fecal occult blood test apparatus 1 of the first embodiment, only different parts will be described, and the same parts will be described as the first. The same reference numerals as those of the embodiment of FIG.

In the fecal occult blood test apparatus of the second embodiment, the lid body 5 of the stool collection device 2 is configured by using the cylindrical body 22 having an opening at the top. An annular protrusion 22a that protrudes inward is formed near the upper end of the inner peripheral surface of the cylindrical body 22, and an elastic plate 23 is fixed to the upper portion of the annular protrusion 22a. The stool collecting rod 6 is fixed to the lower surface of the elastic plate 23. The elastic plate 23 is made of a material having rubber elasticity such as natural rubber or synthetic rubber. Therefore, by pressing the elastic plate 23 with a finger, the stool collection bar 6 can be easily moved downward.

A plate 24 is fixed so as to cover the upper end of the cylindrical body 22. The plate 24 is made of synthetic resin, metal, or the like and is configured to have a certain degree of rigidity so that the elastic plate 23 is not accidentally pressed by a finger. Further, the plate 24 is partly projected to the outside of the outer peripheral surface of the cylindrical body 22. The protruding portion 24a is provided to facilitate the removal of the plate 24 from the upper end surface of the cylindrical body 22.

In the second embodiment, the structure of the stool collection device 2 is different from that of the stool collection device 2 of the first embodiment as described above. The other points are similar to those of the first embodiment. Next, a method of using the fecal occult blood test apparatus 21 of the second embodiment shown in FIG. 3 will be described in more detail with reference to FIGS. 4 to 10.

As shown in FIG. 4, a stool sample is collected by using the stool collection device 2 to pierce the feces A with the stool collection rod 6 of the stool collection device 2 and then pulling up the stool collection device 2. Next, as shown in FIG. 5, the fecal sampling device 2 is attached to the buffer solution container 3. In this case, when the stool collecting rod 6 passes through the through hole 9a of the excess stool removal lid 9, the excess stool A'is discharged onto the upper surface of the excess stool removal lid 9. Therefore, a fixed amount of the stool sample is immersed in the buffer solution 8 while being collected in the uneven portion 6d of the stool sampling rod 6.

Next, as shown in FIG. 6, the feces occult blood test apparatus 21 as a whole is mixed by inversion with the lid 5 of the fecal sampling device 2 screwed onto the buffer solution container 8 and attached. As a result, the stool sample is dissolved in the buffer solution 8 to obtain a stool sample solution.

Next, as shown in FIG. 7, the plate 24 at the upper end is removed to expose the elastic plate 23. Subsequently, as shown in FIG. 8, the elastic plate 23 is pressed with a finger C from above to bend the elastic plate 23 as shown by the one-dot chain line in the figure, break through the sealing material 17, and allow the stool sample solution to flow down into the channel 10. .

Next, as shown in FIG. 9, by pressing the buffer solution container 3 with the finger D, the stool sample solution that has flowed down is dropped from the separation filters 11 and 12. Thereafter, as shown in FIG. 10, by shaking the entire fecal occult blood test apparatus 1, the dropped stool sample solution and the anti-human hemoglobin antibody sensitizing reagent 13 are reacted.

Thereafter, the presence or absence of fecal occult blood is determined by removing the measurement container 4 from the buffer solution container 3 and visually observing the presence or absence of the degree of agglutination on its bottom surface. As described above, by using the fecal occult blood test apparatus 21 of the present embodiment, anyone can easily perform a series of operations from stool collection to determination without requiring special skill.

In the first and second embodiments, the stool collecting rod 6 is illustrated as having a plurality of irregularities 6d. However, the irregularities 6d are not limited to the shapes shown in the figures, and are semi-quantitative. As long as faeces can be collected, it may be configured with various shapes of depressions, protrusions or holes.

Further, the attachment of the stool collection device 2 to the buffer solution container 3 is not limited to the one using the screw described above, and the outer diameter of the buffer solution container 3 and the inner diameter of the stool collection device 2 are selected. By doing so, the buffer solution container 3 may be press-fitted into the stool collection device 2 so as to be attached. Similarly, the mounting structure of the buffer solution container 3 and the measurement container 4 is not limited to the one using the screws as described above, but a structure in which one of them is press-fitted into the other by selecting the diameter of both The leakage of the stool sample solution can be prevented thereby.

[0052]

[Effect of device]

 According to the present invention, a stool collection instrument having the above stool collection rod, a buffer container containing a buffer solution for preparing a stool sample solution, and an anti-human hemoglobin antibody sensitizing reagent for causing an immune reaction. The measuring container with a fixed container is detachably integrated. Therefore, as described above, anyone can easily perform a series of operations from stool collection to determination without requiring much skill.

Moreover, after the inspection is completed, the stool collection device, the container body, and the measurement container can be integrated to prevent the generation of an unpleasant odor and the leakage of the stool sample solution. Therefore, post-inspection processing can be performed hygienically and easily.

Further, when the fecal occult blood test apparatus of the present invention is used, when the solid content is removed from the stool sample lysate by the separation filter, the stool sample lysate is temporarily stored on the separation filter. The concentration of the stool sample solution that is first dropped on the anti-human hemoglobin antibody sensitizing reagent does not decrease. Therefore, since the anti-human hemoglobin antibody sensitizing reagent and the stool sample solution react accurately, it is possible to reliably determine the presence or absence of fecal occult blood.

[Brief description of drawings]

FIG. 1 is a sectional view showing a fecal occult blood test apparatus according to a first embodiment of the present invention.

FIG. 2 is a perspective view of the fecal occult blood test apparatus according to the first embodiment.

FIG. 3 is a sectional view showing a fecal occult blood test apparatus according to a second embodiment.

FIG. 4 is a cross-sectional view showing a step of collecting a stool sample by using the stool occult blood sampling device of the second embodiment.

FIG. 5 is a cross-sectional view showing a step of removing excess stool when attaching the stool collection device to the buffer solution container.

FIG. 6 is a cross-sectional view showing a step of inverting and mixing the fecal occult blood test apparatus.

FIG. 7 is a cross-sectional view illustrating a step of removing a plate.

FIG. 8 is a cross-sectional view for explaining an operation of moving the stool collecting rod downward.

FIG. 9 is a cross-sectional view for explaining an operation of dropping a stool sample solution into a measurement container.

FIG. 10 is a cross-sectional view for explaining a step of reacting a stool sample solution with an anti-human hemoglobin antibody sensitizing reagent.

[Explanation of symbols]

 1, 21 ... Fecal occult blood test device 2 ... Stool collection instrument 3 ... Buffer container 4 ... Measurement container 5 ... Lid 6 ... Stool collection rod 7 ... Sealing material 8 ... Buffer 10 ... Flow path 11, 12 ... Separation filter 13 … Anti-human hemoglobin antibody sensitizing reagent

Claims (1)

[Scope of utility model registration request] 1. A stool collection instrument having a lid and a stool collecting rod for collecting a stool sample, the stool being fixed to the inner surface of the lid so as to be movable in the longitudinal direction. A buffer solution container to which the toilet device is detachably attached and in which a flow path leading to the outside is formed in the lower part, and a buffer solution stored in the buffer solution container for dissolving the stool sample A sealing material that is pierced by moving the fecal sampling rod so as to close the flow path, and a solid material in the stool sample solution that is provided on the downstream side of the sealing material in the flow path. Separation filter for removing components, a measurement container that is detachably attached to the buffer solution container, and is in communication with a flow path in the attached state, and an anti-human being fixed in the measurement container Equipped with hemoglobin antibody sensitizing reagent A fecal occult blood test device.