JP2001108670A - Stool collecting container for determining stool occult blood and method for determining stool occult blood - Google Patents

Abstract

PROBLEM TO BE SOLVED: To enhance an efficiency of determining for executing a secondary determination for a specimen decided to be positive by a primary screening capable of deciding via the primary screening only in one time feces collecting in the case of determining the specimen irrespective of positive or negative of the specimen. SOLUTION: The stool collecting container is used to determine a stool occult blood and can decide the presence or absence of occult blood in the container. In this case, a determining reagent is contained in the container or in another container brought into close contact with a stool collecting container body, the presence or absence of the occult blood in the container is decided, and the sample is further precisely measured.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a fecal occult blood test container and a fecal occult blood test method used for clinical tests.

[0002]

2. Description of the Related Art A chemical test and an immunological test are used to test for fecal occult blood due to gastrointestinal bleeding. The chemical test is a method in which the peroxidase-like activity of hemoglobin is determined by oxidative coloring of chromogen. In this case, apply stool to test paper in which chromogen is blotted on filter paper,
A coloring solution of hydrogen peroxide was dropped on the coating stool to determine the presence or absence of coloring. On the other hand, the sample to be used for the immunoassay is a suspension of stool in a buffer solution filled in a stool collection container, and is used for immunochemical measurement such as immunolatex agglutination, hemagglutination or immunochromatography. Method.

[0003]

It has been pointed out that the conventional chemical test method is simple, but inferior in specificity to the immunological method. On the other hand, immunoassays have higher specificity and higher reliability than chemical methods, but cannot be detected without the use of special equipment or instruments for testing, making it difficult to measure a large number of specimens or expensive. Inspection costs were required. On the other hand, JP-A-9-15239 and JP-A-9-15
In 240, an immunochromatographic apparatus is disclosed that is held inside or outside the stool collection container, but also in this case, an immunoassay is performed regardless of whether the sample is negative or positive, Again, not only is a high inspection cost required, but the apparatus is complex and bulky, which is not practical. The present invention is only a single stool collection, the primary screening determination is possible, only the sample that was determined to be positive in the primary screening using the same sample, the secondary specificity is highly reliable The present invention relates to a method for testing by an immunological method and a stool collection container that enables the method.

[0004]

Means for Solving the Problems As a result of intensive studies, the present inventors have previously contained a test reagent in a stool collection container which can determine the presence or absence of occult blood, and performed stool collection simultaneously with stool collection in the container. Thus, the present invention was devised and developed to enable the determination of the presence or absence of stool, and then to devise and develop a stool container capable of providing the same sample to an inspection method based on a different principle or method, if necessary.

According to the method of the present invention, the presence or absence of an occult blood reaction can be confirmed by taking a predetermined amount of stool into a stool collection container. If necessary, if a positive sample is tested using a test method based on a different principle and method, for example, an immunochemical assay, the number of samples to be used for testing using specialized equipment and devices is significantly reduced, and Efficiency can be improved. In addition, by combining two types of inspections based on different principles or methods, the accuracy and reliability of the inspection result are improved.

As a specific embodiment, a solution containing a redox dye, guaiac, orthotolidine or tetramethylbenzidine, and hydrogen peroxide as an oxidizing agent is previously filled in a stool collection container, and the solution is placed in the solution. Suspend a fixed amount of stool. If there is occult blood in the stool, a color reaction occurs due to the peroxidase activity of hemoglobin. By visually determining the color tone, the presence or absence of occult blood can be determined. The redox dye and the oxidizing agent may be filled in a state of being mixed in advance, or may be separately filled and held so that they can be mixed simultaneously with or after the defecation operation. The redox dye may be filled in a solution or in a dry state.

[0007] The shape of the stool collection container is not particularly limited. For example, a stool container as shown in FIG. 1 is filled with a mixed solution of tetramethylbenzidine and hydrogen peroxide solution, and when stool is collected with a stool stick, if hemoglobin is present, it is colored. On the other hand, if not present, no coloring is observed. Not only redox dyes but also fluorescent substances and luminous substances can be used. For example, it is possible to determine the presence or absence of fecal occult blood by preparing a stool solution containing luminol or lucigenin, collecting stool in it, adding hydrogen peroxide solution, and observing the presence or absence of luminescence. it can. Further, a stool solution containing 3- (4-hydroxyphenyl) propionic acid is prepared, and after collecting stool therein, hydrogen peroxide solution is added.
By observing the presence or absence of fluorescence, the presence or absence of fecal occult blood can also be determined. As described above, if the stool collection container of the present invention is used, the presence or absence of occult blood can be determined only by collecting stool without being subjected to a separate test. Then, in order to improve the accuracy of the test, it is also possible to measure only the sample which has been colored by a different measurement principle, for example, an immunochemical measurement method.

[0008]

EXAMPLES The present invention will be further described below with reference to examples, but the present invention is not limited to the examples.

[0009]

Example 1 1 W / V% bovine serum albumin, 0.1
Tetramethylbenzidine and aqueous hydrogen peroxide were added to a 10 mM phosphate buffer (pH 6.0) containing W / V% ciploxacin and 0.15 M sodium chloride so that the final concentrations were 0.3 mM and 0.1 mM. , 0.22μ
The stool solution was prepared by removing bacteria by filtration. Fig. 1
1 mL was dispensed into the container shown in (1). Using the stool collection container thus prepared, 50 cases of stool collection were performed, and the result of fecal occult blood was determined. As a result, as shown in Table 1, 10 cases were determined to be positive. Further, all 50 cases were immunoassayed by a commercially available immunochromatography method (trade name: Nanotrap Hemo). As a result, all of the 40 cases that showed a negative judgment in the stool collection container also showed a negative result by the immunochromatography method. On the other hand, 3 cases out of 10 cases that showed a positive result in the stool collection container showed a positive result by the immunochromatography method.

[0010]

[Table 1]

[0011] As a result of the above, a sample which is determined to be negative by the determination in the stool collection container is also determined to be negative by the immunochromatography method.
It turns out that the second measurement is unnecessary. Therefore, it is possible to perform the second measurement only on the sample determined to be positive in the determination in the stool collection container. By doing so, in the above example, only the ten cases need to be subjected to the secondary measurement, and the number of inspections can be reduced to one fifth.

[0012]

Embodiment 2 In the example of FIG. 1, a test reagent 5, for example, a mixture of tetramethylbenzidine and a hydrogen peroxide solution is dispensed into a stool collection container main body 1. If stool collected by the stool collection rod 2 is dispersed in the test solution and occult blood is present, the presence or absence of occult blood can be determined by changing the color tone of the test reagent in the container. When the inspection is performed by another method, the inspection can be performed by dropping the sample from the dropping port.

[0013]

[Embodiment 3] In the example of FIG. 2, a part of the test reagent is held in a solution in the body of a stool collection container, and stool collection is performed with a stool collection bar as in the second embodiment. Thereafter, by shifting the stopper ball 6, another part of the test reagent previously held in the site 7 is mixed with the collected sample to cause a reaction, and the presence or absence of occult blood is determined. The test reagent can hold, for example, a hydrogen peroxide component and a color former separately on the main body side and the other side, respectively. One of them can be held in a solid state such as a powder or a tablet as well as a liquid. Further, in this example, only a suitable buffer solution is dispensed into the main body, and the ball is moved after the stool collection, so that the site 7 in which all the test drugs similar to those in Example 1 are held in advance. It is also possible to perform an inspection by moving the liquid.

[0014]

Embodiment 4 In the example of FIG. 3, a part of the test reagent is sealed in a thin glass container or the like, and after collecting stool as in Examples 2 and 3,
The reaction is performed by applying pressure from the outside and breaking the inner container. Also in this case, the reagent in the inner container 8 can be both liquid and solid. Then, similarly to the third embodiment, it is also possible to hold all of the test reagents in the internal container 8 and perform the test by breaking the internal container 8.

[0015]

Fifth Embodiment In the example of FIG. 4, after collecting the stool in the same manner as in the second, third or fourth embodiment, the part 9 holding all or a part of the test agent is needle-shaped through the dropping port. It can be inspected by piercing with an object.

[0016]

Embodiment 6 In the example of FIG. 5, only the buffer solution or a part of the components of the test reagent is contained in the stool collection container main body. One end of the stool container is welded with a molded product or a seal 10 made of a material that can be pierced from the outside. Another container 11 other than the stool collection container main body is prepared outside the container, and all or a part of the test agent is contained in this container. The test reagent to be included here does not necessarily need to be in a liquid state, and a powder or a tablet can be used as appropriate. These containers are prepared so that they can be fitted with each other. When the safety device 13 is removed and the two containers are fitted together, the hollow projecting portion 12 provided on the outer container causes The liquid in which the bottom or seal 10 is broken and the stool is dispersed can move toward the outer container 11.
At this time, the test reagent acts to determine the presence or absence of occult blood. After the determination of negative or positive, the sample can be dropped from the other end 4 of the external container to confirm only the positive sample, and can be used for precision measurement.

[0017]

The present invention relates to a stool collection container used for testing fecal occult blood,
A stool collection container characterized in that the presence or absence of occult blood can be determined in the stool collection container.By using the present invention, after determining the presence or absence of occult blood in the stool collection container, the sample is subjected to more precise measurement. Thus, the primary screening can be determined only by one stool collection. The efficiency of the test can be improved by performing the secondary test on only the sample determined to be positive in the primary screening.

[Brief description of the drawings]

FIG. 1 is an explanatory view of a stool collection container having a test reagent contained in a stool container main body.

FIG. 2 is an explanatory view of a stool collection container in which a test reagent and a stool collection container main body are stoppered with a ball-shaped one.

FIG. 3 is an explanatory diagram of a stool collection container in which a test reagent and a stool collection container main body are sealed in a thin glass container or the like.

FIG. 4 is an explanatory view of a stool container having a shape in which a part of the test reagent is held separately from the body of the stool container and the test is performed by piercing with a needle.

FIG. 5 is an explanatory view of a stool collection container having a shape in which a test reagent held in separate containers and a stool collection container main body are fitted to each other to move a test agent to the stool collection container.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Stool collection container main body 2 ... Stool collection rod 3 ... Stool scraping part 4 ... Drip port 5 ... Stool dispersion buffer 6 ... Movable ball stopper 7 ... Inspection Reagent holding part 8 ... Test reagent holding container 9 ... Test reagent holding part 10 ... Molded bottom or seal 11 ... External container 12 ... Hollow projecting part 13 ... Safety device

Claims (3)

[Claims] 1. A stool collection container used for testing occult blood in feces, wherein a test reagent capable of determining the presence or absence of occult blood is contained in the container. 2. The container according to claim 1, wherein the test reagent is a substance containing a chromogen, a phosphor, and a luminous body. 3. A fecal occult blood test method using a stool collection container, characterized in that a test reagent capable of determining the presence or absence of occult blood is contained in the container in advance.