JPH0552757U - Inspection tool - Google Patents

Abstract

(57) [Summary] [Structure] (A) A closable sample collection container having a bottom and a lid formed of a liquid-impermeable membrane, at least a part of which is rupturable, and (B) the sample collection A breakable member that can be liquid-tightly connected to the container to break the liquid-impermeable membrane at the bottom of the sample collection container, a suction member that sucks up the liquid in the sample collection container, and a specific substance contained in the sucked liquid 2. An inspection tool comprising a color detection part that carries a coloration material that changes color according to the component to be inspected, and a detection tool that can be liquid-tightly connected to the sample collection container. [Effect] Since all the steps other than the step of collecting a sample in the sample collection container (A) can be performed with the inspection tool sealed, there is a risk of contamination or infection by the sample and discomfort during inspection or disposal. It is safe and can be handled safely, and is particularly suitable for testing unpleasant samples such as feces and samples containing dangerous components.

Description

[Detailed description of the device]

[0001]

[Industrial application]

 The present invention relates to a sample testing tool. More specifically, the present invention relates to a sample inspection tool that can hygienically and easily test a sample in a sealed state without causing contamination or infection by the sample.

[0002]

[Prior Art]

 For example, a test for fecal occult blood detects bleeding from the digestive tract and is effective as a means for early detection of cancer, ulcer, etc. in the digestive tract. The immunological detection method for fecal occult blood includes the latex agglutination method and reverse passive red blood cells in which a fecal suspension is added to latex or animal erythrocytes sensitized with an anti-human hemoglobin antibody, and latex or erythrocyte agglutination is visually determined. Aggregation methods are known, but these methods have a problem that determination of an aggregation image is difficult and requires skill.

Further, when stool occult blood is tested by these immunological detection methods, since stool, which is a sample, has a low water content, stool is suspended in a diluent and then diluted stool is sampled. It is usual practice to take the suspension from the container, drop it into an open container such as a plate to cause an agglutination reaction, and visually determine the agglutination image under an open system. Therefore, there was a risk of infection and contamination due to the stool diluent due to carelessness and malfunction during inspection. Moreover, even when the tested specimens are discarded, there is a problem of stool contamination and infection during the treatment of wastes because the open reaction container is used.

On the other hand, as a simple analysis method by an immunological method, there is an immunochromatographic binding assay method. In this method, by using a coloring substance that is colored or changes color due to the component to be inspected, coloring, or agglomeration of a coloring substance as the labeling substance, it is only necessary to bring the detection tool into contact with the test liquid in one step. The feature of this method is that the detection of the target component can be easily judged by the presence or absence of color change or color change, and it is used for analysis of hCG in urine.

The application of the immunochromatographic binding assay method, which uses a coloring substance or the like as a labeling substance, to the detection of fecal occult blood, is simple and easy to determine. It is considered to be effective in solving the difficulty of the occult blood test and simplifying the operation.

However, even when the immunochromatographic binding assay method is applied to the detection of fecal occult blood, the fecal sample must be suspended in a liquid in advance in order to cause the chromatographic phenomenon because the water content of fecal sample is low. It is necessary to dilute it before supplying it to the chromatographic medium, and there is a risk of stool contamination and infection during diluting stool, subsequent chromatographic inspection, and disposal. Furthermore, not only the fecal occult blood test but also the biomaterial test is generally performed in an open system or a semi-open system, and there is always a risk of infection or contamination, and discomfort.

[0007]

[Invention content]

 From the above points, the present inventor can safely and easily carry out the test without any risk of contamination by the sample or infection of the sample during the test of the sample, particularly the biomaterial test such as the test of fecal occult blood. Moreover, I have continued my research with the aim of obtaining means that can be performed clearly.

As a result, it is necessary to provide a specific detection unit carrying a coloring component that is colored, colored or changes in color depending on the component to be detected in the sample, and further it is necessary to dilute the sample such as stool or the like with little water content or dilute it. When measuring a sample, collect the sample in a specific sealable collection container that contains a suspension or dilution liquid for that purpose, and then connect the detection part and the collection container to a liquid sample or suspension or dilution. If the structure is such that samples that have been liquefied by the above method can be liquid-tightly coupled to each other so that they do not leak to the outside and that the liquid sample in the collection container is sucked up by the detection part and develops or changes color due to the coloring component. The inventors have completed the present invention by discovering that the above objectives can be achieved.

That is, the present invention provides: (A) a bottom part formed of a liquid impermeable membrane, at least a part of which is rupturable; a sealable sample collection container having a lid; and (B) the above A rupturable member that can be liquid-tightly connected to the sample collection container and that ruptures the liquid-impermeable membrane at the bottom of the sample collection container, a suction member that sucks up the liquid in the sample collection container, and a suctioned liquid An inspection tool characterized by comprising a detection tool capable of liquid-tightly connecting to a sample collection container, which is provided with a color detection unit carrying a coloration material that exhibits a color depending on a specific test target component contained in ..

In the present invention, the sample collection container (A) is formed of a liquid-impermeable membrane (hereinafter referred to as “liquid-tight rupturable membrane”) having a rupturable at least part of its bottom, and a lid. Any other structure, shape, material, etc. may be used as long as the liquid in the sample collection container does not leak out of the container when sealed with the body and can be liquid-tightly connected to the detection tool (B). In addition, when measuring a sample with low water content such as stool or a sample that needs to be diluted, it is advisable to put a liquid for suspension or dilution in the sample collection container (A).

Although not limited thereto, as an example of a typical structure of the sample collection container (A), the sample collection container is a cylindrical body made of plastic or other material, and its bottom is thin. It is formed of a liquid-tight rupturable film made of plastic or the like, and has a means (for example, a screw part) that can be liquid-tightly connected to the detection tool (B) at the bottom thereof, and has an upper opening of the tubular body. Examples thereof include those that can be sealed with a lid.

Further, the detection tool (B) can be liquid-tightly connected to the sample collection container (A), and the liquid-tight rupturable membrane at the bottom of the sample collection container (A) is broken to break the sample collection container. A breaking member (hereinafter referred to as "membrane breaking member") for allowing the liquid sample in (A) to be sucked up by the sucking member, a sucking member for sucking the liquid in the sample collecting container, and included in the sucked liquid It is equipped with a color detection unit that carries a coloring material that changes color depending on the specific component to be inspected, such as coloring, coloring or agglomeration of coloring substances. Any other structure, shape, or material may be used as long as the change in color due to aggregation or the like can be visually judged from the outside.

The liquid suction member used in the measuring tool (B) is preferably made of a material capable of smoothly and promptly absorbing a liquid sample or a sample liquefied by a diluent or the like. Examples thereof include liquid absorbent materials such as natural, semi-synthetic or synthetic hydrophilic fibers, fleeces or cloths made of them, paper products, water-absorbing sponges, water-absorbing inorganic or organic particles and the like. If the liquid-absorbent material itself is not shape-retaining, such as inorganic or organic powder, make it conform to the shape of the measuring tool (B) and harden it with an adhesive while maintaining its porous structure. It is recommended to use it in a porous bag.

As the carrier for carrying the coloring material in the measuring tool (B), paper, cloth, fiber fleece, chromatographic medium made of inorganic or organic powder or the like, multi-pore sponge, ceramics, etc. Can be used.

The type of coloring material in the sample detection tool (B) is appropriately selected according to the type of sample using the inspection tool of the present invention, the type of detected component to be detected by the inspection tool of the present invention, and the like. To do. For example, when the test device of the present invention is designed for the test of occult blood contained in feces, etc., the peroxidase-like action of hemoglobin in blood, which is a substance that specifically binds to human hemoglobin labeled with a coloring substance, is used. A combination of a colored organic hydroperoxide and a specific color indicator can be used as the color substance.

Although not limited thereto, as an example of a typical structure of this detection tool (B), a detection target component in a sample is provided in a case made of a cylindrical plastic or the like with an open lower part. A liquid-absorptive carrier carrying a color-forming material showing a color reaction is positioned, and a case part corresponding to the color-developing part is formed of a transparent body so that it can be seen from the outside. At least a part of the liquid suction member connected to the carrier is provided so as to protrude outside the case, and the liquid suction member is connected to the liquid suction member and is capable of rupturing the liquid-tight rupturable film of the sample collection container (A). The thing provided with the breaking member can be mentioned.

Hereinafter, the structure of the test device of the present invention and the method of testing a sample by the test device will be specifically described with reference to the drawings, taking a test of occult blood in feces as an example.

1 and 2 are views showing a state before use of a fecal occult blood test instrument according to an embodiment of the present invention. FIG. 1 shows a sample collection container (A) and FIG. (B) is shown. FIG. 3 is a diagram showing a state in which the specimen collection container (A) of FIG. 1 and the detection tool (B) of FIG.

The sample collection container (A) comprises a tubular body 1 and a cap 2 for sealing the tubular body. A rupturable liquid-tight rupturable film 3 such as a plastic film is attached to the rib 4 in a liquid-tight manner by adhesion or the like on the bottom of the cylindrical main body 1 to form a bottom portion. Below the bottom of the cylindrical main body 1, there is formed a connecting portion 6 in which, for example, a female screw 5 is cut in order to liquid-tightly connect the sample collecting container (A) with the measuring tool (B). Further, a screw portion 7 that is screwed with the cap 2 is formed on the outer periphery of the upper opening of the cylindrical main body 1.

A screw portion 8 is formed on the inner periphery of the cap 2 for screwing with the cylindrical body 1 to seal the sample collection container (A), and the inside of the cap 2 collects feces. A stool specimen collecting rod 9 is attached for the purpose. The stool sample collecting rod 9 has a stool collecting section 10 at its tip, and the tip of the stool collecting section 10 is uneven so that stool can be collected easily. The stool collection unit 10 is not limited to the uneven shape as shown in FIG. 1, but may be earpick-shaped, for example. The feces collecting rod 9 may be formed integrally with the cap 2 or may be detachably attached to the cap 2. A rubber packing 11 for sealing is provided in the cap 2.

The material of the tubular body 1 and the cap 2, the liquid-tight rupturable membrane 3, the fecal sample collecting rod 9 and the like is not particularly limited, but liquid-tightness, alteration resistance, light weight, mass production are made of plastic. It is preferable from the points of possibility and economical efficiency. A diluent 12 for suspending a stool sample is placed in the cylindrical body 1. In the inspection tool of the present proposal, the diluent 12 may be distributed and sold in a state where the diluent 12 is put in the tubular body in advance, or the diluent 12 may be put in the tube body at the time of inspection. It is convenient to enter.

Then, after the stool is collected by the stool sample collecting rod 9 attached to the cap 2, the cap 2 is screwed into the tubular body 1 and the collected stool is put into the sample collecting container (A) for dilution. By suspending it in the liquid 12 and sealing it at the same time, the collected feces can be stored and transported in a liquid-tight manner without leaking to the outside.

The detection tool (B) has a pointed tip for breaking the liquid-tight rupturable membrane 3 at the bottom of the sample collection container (A) at the open end of the liquid-impermeable case 13 closed on one side. And a porous liquid suction member 15 for sucking up the liquid in the specimen collection container (A). Further, the conical membrane breaking member 14 is provided with a liquid passage hole 16 for sucking up the liquid in the cylindrical main body 1 in a radial shape. The porous liquid suction member 15 is connected to a porous chromatographic carrier 17, and the porous chromatographic carrier 17 is further connected to a porous pad 18 for promoting liquid suction. In addition, the case 13 may be provided with a small hole through which air in the detector (B) does not pass, but which allows the air in the detector (B) to escape to the outside.

A substance that specifically binds to human hemoglobin labeled with a coloring substance is retained in the area 19 of the porous chromatographic carrier 17 in a chromatographically transferable state, and further in the area 20, human hemoglobin. The substance that specifically binds to is immobilized and retained in a state in which it cannot be moved by chromatography. Since the area 19 serves as a color detection section, a transparent detection window 21 is provided at a location corresponding to the area 20 of the case 13 so that the color state can be seen from the outside. Further, the detecting tool (B) is provided with a male screw 22 for connecting the detecting tool (B) to the connecting portion 6 of the sample collecting container (A) in a liquid-tight manner by connecting to the conical membrane breaking member 14. There is. In the present invention, the sample collection container (A) and the detection tool (B) may be distributed and sold as an integrated unit, or each may be distributed and sold separately.

Next, the state in which the occult blood in the fecal sample is being inspected by the above-mentioned sample collection container (A) and detection tool (B) will be described with reference to FIG. As described above, after the stool is collected by the stool sample collecting rod 9 attached to the cap 2, the stool collected by screwing the cap 2 into the tubular body 1 is put in the sample collecting container (A) and the diluent 12 Suspend in and seal at the same time. After transporting and storing this as needed, the bottom of the sample collection container (A) should be attached to the conical breaking member 13 of the detection tool (B) while keeping the sample collection container (A) in a sealed state. The female screw 5 of the connecting portion 6 of the sample collection container (A) and the male screw 22 of the detection tool (B) are screwed together, to connect the sample collection container (A) and the detection tool (B). Connect liquid-tightly.

As a result, the conical membrane rupturing member 14 of the detection tool (B) ruptures the liquid-tight rupturable membrane 3 of the sample collection container (A) and at the same time the sample in the sample collection container (A) passes through the liquid passage hole 16. The liquid is sucked up by the porous liquid sucking member 15, and the liquid is further sucked up and moved to the porous chromatograph carrier 17 and the porous pad 18. At that time, if occult blood is contained in the feces, hemoglobin in the blood also moves at the same time, and is specific to the substance that specifically binds to the human hemoglobin labeled with the coloring substance in the area 19 of the porous chromatographic carrier 17. Binding, the bound substance further moves toward the porous pad 18, and is trapped by the substance specifically binding to the human hemoglobin immobilized on the region 20 of the porous chromatographic carrier 17, It is fixed at 20 and coloration due to a coloring substance is shown at that position. Therefore, the presence or absence of occult blood in the feces can be inspected by visually inspecting the presence or absence of coloring in the area 20 through the transparent detection window 21 of the detection tool (B).

As is apparent from the above description with reference to FIGS. 1 to 3, when the inspection tool shown in FIGS. 1 to 3 is used, a step of collecting feces in the sample collection container (A) With the exception of the above, all other steps can be performed with the test tool sealed, so there is no risk of contamination with a stool sample or infection during testing, it can be handled safely, and there is an unpleasant feeling. You don't have to. Moreover, since the inspection tool can be disposed of in a sealed state even after the inspection is completed, contamination or infection does not occur even at the time of disposal. In addition, the presence or absence of occult blood in the stool can be very easily visually inspected by the presence or change of the coloration state.

The inspection tool shown in FIGS. 1 to 3 is an example of the inspection tool of the present invention, and the inspection tool of the present invention is not limited to those shown in FIGS. In the sample collection container (A) of FIG. 1, the entire bottom is formed of a liquid-tight rupturable film, but only a part of the detection tool (B) where the film rupture member is located is a liquid-tight rupturable film. You may form more. Further, the membrane breaking member and the liquid-tight rupturable membrane do not necessarily have to be provided in the center of the container. Further, for example, the sample collection container (A) can have a shape other than a tubular shape. The liquid-tightness rupturable membrane rupturable member provided at the bottom of the sample collection container (A) has a structure in which, for example, a liquid suction member other than that shown in FIG. be able to. Further, the chromatographic carrier may have a structure other than the strip shape shown in FIG. Further, the test device of the present invention is not limited to the detection of occult blood in feces and can be used for other specimens.For example, when the specimen is liquid rather than solid such as feces, a cap is used. It is not necessary to provide a sample collecting rod in.

[0029]

[Effect of the device]

 As described above, when the test device of the present invention is used, all other steps except the process of collecting the sample in the sample collection container (A) should be performed with the test device sealed. Therefore, there is no risk of sample contamination or infection at the time of inspection, and it can be handled safely. Moreover, since the inspection tool can be disposed of in a sealed state even after the inspection is completed, no contamination or infection occurs even when it is disposed.

In particular, when the test device of the present invention is used for the test of fecal occult blood, all the steps except the stool sampling step can be performed in a sealed manner, so that the conventional unpleasant feeling associated with the stool test can be avoided. The problem can be resolved. Further, with the inspection tool of the present invention, the presence or amount of the component to be inspected in the sample can be visually inspected very easily by the presence or absence of the coloration state or the color change. The test device of the present invention can be used for all tests of a sample capable of detecting a specific component depending on the presence or absence of coloration, and among them, a sample such as feces that is uncomfortable to handle and a dangerous component can be used. It is particularly suitable for testing specimens containing it.

[Brief description of drawings]

FIG. 1 is a view showing an embodiment of a sample collection container (A) of a test device of the present invention.

FIG. 2 is a view showing an embodiment of the detection tool (B) of the test tool of the present invention used in combination with the sample collection container (A) of FIG.

FIG. 3 is a diagram showing a state in which a fecal occult blood test is performed using the sample collection container (A) of FIG. 1 and the detection tool (B) of FIG.

[Explanation of symbols]

A sample collection container B measuring tool 1 tubular body 2 cap 3 liquid-tight rupturable membrane 4 rib 5 female screw 6 connecting part 7 screw part 8 screw part 9 stool sample collecting rod 10 stool collecting part 11 rubber packing 12 diluent 13 liquid Impermeable case 14 Conical membrane rupturing member 15 Porous liquid suction member 16 Liquid passage hole 17 Porous chromatographic carrier 18 Porous pad 19 Coloring substance A substance that specifically binds to labeled human hemoglobin can move Area 20 retained in the area 20 Area where the substance that specifically binds to human hemoglobin is immobilized so as not to be transferred 21 Transparent detection window 22 Male screw

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁵ Identification code Internal reference number FI technical display location G01N 33/543 P 7906-2J

Claims (1)

[Scope of utility model registration request] 1. A sealable sample collection container having (A) a bottom formed of a liquid-impermeable membrane, at least a portion of which is rupturable, and a lid, and (B) the sample collection container described above. A breaking member that can be connected in a liquid-tight manner and that breaks the liquid-impermeable membrane at the bottom of the sample collection container, a suction member that sucks up the liquid in the sample collection container, a specific member contained in the sucked liquid 2. An inspection tool comprising: a color detection part that carries a coloration material that exhibits a color depending on the component to be inspected, and a detection tool that can be liquid-tightly connected to the sample collection container.