WO2013141103A1

WO2013141103A1 - Stool assay kit

Info

Publication number: WO2013141103A1
Application number: PCT/JP2013/056954
Authority: WO
Inventors: 本田　稔; 昌克冨田
Original assignee: ニプロ株式会社
Priority date: 2012-03-21
Filing date: 2013-03-13
Publication date: 2013-09-26
Also published as: JPWO2013141103A1; JP6191596B2

Abstract

With this stool assay kit, a stool collection container (500) containing a suspension liquid of dissolved stool for stool assay purposes is inserted from the distal end side thereof into an insertion space (104) of a detector instrument (100), and the stool collection container (500) is mounted in the detector instrument (100), causing a needle (105) to puncture a thin film part (524), whereupon the suspension liquid passes from a hollow passage (106) through a filter (108) and permeates a test strip (201). It is possible thereby to provide a stool assay kit provided with a structure free of splatter of the suspension liquid of dissolved stool, without any effort on the part of the assay technician.

Description

Stool test kit

The present invention collects stool used as a sample for clinical testing, particularly a sample for detecting occult blood, enzymes, viruses, etc., and puts the stool into a stool dissolution buffer in a container to form a suspension. The present invention relates to a stool test kit including a stool collection container (specimen container) that is held in a state and a test instrument that performs a stool test using the suspension.

The fecal occult blood test is widely used for screening for colorectal cancer and rectal cancer. In general, a fecal occult blood test is performed by preparing a sample in a hospital based on stool collected at home. In qualitative analysis using latex, because the amount of stool is restricted when preparing a sample, the specified stool collection rod is used. However, an accurate amount of stool can be collected using the stool collection rod. In the past, after collecting stool, the stool collection rod was wiped with paper etc. to remove the extra stool.

However, the stool is dirty and has a strong odor, and when wiping with paper, the stool may accidentally adhere to the hand. The sample creator often suffers from bad odors because the sample container cap is opened and collected on a stool collection rod. In the case of a conventional sample container containing a stool dissolution buffer, especially in the case of some subjects such as the elderly, even if the lid was closed after stool collection, it could not be completely closed, and liquid leakage occurred during transportation. May occur.

In order to solve the above problems, JP-A-10-185912 (Patent Document 1), JP-A 2007-47042 (Patent Document 2), and International Publication No. 2007/069731 (Patent Document 3). Is used.

JP-A-10-185912 JP 2007-47042 A International Publication No. 2007/069731

The stool collection container disclosed in each of the above patent documents is provided with a filter in order to prevent stool that cannot be completely dissolved in the stool dissolution buffer from being released to the inspection instrument. As a result, when the stool suspension is dropped onto the test instrument from the lower end of the stool collection container (drops on the chromatographic filter paper), only the suspension in which the stool is dissolved is dropped onto the test instrument. Is done.

When the stool collection container having the above-described configuration is used, the inside of the filter is filled with a stool dissolution buffer in which the stool is not dissolved at the beginning. For this reason, penetration of the fecal suspension into the interior of the filter should not be expected before the test. When dropping the stool suspension from the stool collection container onto the inspection instrument, it is necessary to perform the inspection without using the first few drops, and the work procedure is troublesome.

When dropping a stool suspension from a stool collection container onto an inspection instrument, the suspension may splash accidentally. For the inspection worker, the splashed suspension is uncomfortable and unsanitary.

Accordingly, the present invention has been made in view of the above problems, and provides a stool inspection kit having a structure in which a suspension in which stool is dissolved does not splash without causing an inspection operator to take time. There is.

In the stool test kit based on the present invention, the stool is collected, the stool is placed in the stool dissolution buffer in the container, and the stool collection container for holding the suspension in which the stool is dissolved, and the above-described suspension A stool inspection kit comprising an inspection instrument for inspecting the stool using a turbid liquid, comprising the following configuration.

The stool collection container has a rod-shaped stool collection rod having a stool collection portion for collecting stool at the end, a stool collection rod insertion port on one end side, and a thin film portion on the other end side, and contains the stool collection rod And a container body for storing the stool dissolution buffer.

The inspection instrument includes a housing part that defines a cylindrical insertion space in which the container body can be inserted along the axial direction thereof, and a body that is provided integrally with the housing part and has an inspection member housing space therein. A suspension inspection member housed in the inspection member housing space, a needle provided in the housing portion, having a hollow path with one end open and the other end communicating with the inspection member housing space; A filter housing part provided between the inspection member housing space and the hollow path, and a filter housed in the filter housing part.

By inserting the stool collection container containing the suspension in which the stool is dissolved into the insertion space of the inspection instrument from the distal end side, and attaching the stool collection container to the inspection instrument, the needle is Through the thin film portion, the suspension passes through the filter from the hollow path and permeates the suspension inspection member.

In another embodiment, the main body is provided in parallel to the direction in which the needle extends, the suspension inspection member has a strip shape, and one end of the suspension inspection member is attached to the filter. The suspension test member is provided in contact with the other end, and the other end of the suspension test member is accommodated in the test member accommodation space so as to extend toward the distal end side of the needle.

In another embodiment, the one end of the suspension test member is located on the opposite side of the other end side of the needle across the filter, and the suspension test member is bent into a substantially L shape. Thus, the other end of the suspension inspection member is accommodated in the inspection member accommodation space so as to extend toward the distal end side of the needle.

In another embodiment, the main body portion has a window portion through which a part of the suspension inspection member accommodated in the inspection member accommodation space can be visually recognized.

In another embodiment, the inspection instrument maintains the state in which the window is on the upper surface in both the mounted state and the unmounted state of the stool collection container in the insertion space. It has a mounting side surface located on the opposite side to the main part of the storage part.

In another form, the inspection instrument is placed to stand with the other end side of the needle as the lower side in both the mounted state and the unmounted state of the stool collection container in the insertion space. Has a bottom surface.

According to the stool test kit based on the present invention, a stool test kit is provided that has a structure in which a suspension in which stool is dissolved does not splash without causing the inspection operator to take time. Is possible.

It is a front view which shows the container for stool collection used for the kit for stool inspection of embodiment. It is a perspective view which shows the structure of the stool collection rod of the container for stool collection of embodiment. It is a longitudinal cross-sectional view which shows the structure of the container main body of the container for stool collection of embodiment. It is the whole perspective view from the front side of the inspection instrument of an embodiment. It is a whole perspective view from the back side of the inspection instrument of an embodiment. FIG. 6 is a cross-sectional view taken along line VI-VI in FIG. 4. It is a schematic diagram which shows the mounting state of the container for stool collection to the test | inspection instrument of embodiment. It is a longitudinal cross-sectional view which shows the state by which the container for stool collection was mounted | worn with the test | inspection instrument of embodiment. It is the whole perspective view from the front side of the inspection instrument of other embodiments. It is a whole perspective view from the back side of the inspection instrument of other embodiments. It is a whole perspective view which shows the state by which the container for stool collection was mounted | worn with the test | inspection instrument of other embodiment. It is the whole perspective view from the front side of the inspection instrument of other embodiments.

Hereinafter, a fecal occult blood determination kit according to an embodiment of the present invention will be described with reference to the drawings. In the embodiments described below, when referring to the number, amount, and the like, the scope of the present invention is not necessarily limited to the number, amount, and the like unless otherwise specified. It is planned from the beginning to use a combination of the configurations shown in the embodiments as appropriate.

(Embodiment: Kit for stool inspection)
Hereinafter, the structure of the stool test kit in the present embodiment will be described with reference to FIGS. The stool test kit according to the present embodiment collects stool, puts the stool into a stool dissolution buffer in the container, and holds a stool-dissolving suspension 500, and a stool dissolution container. A stool inspection kit including an inspection instrument 100 for inspecting stool using a suspension.

(Stool collection container 500)
The structure of the stool collection container 500 will be described with reference to FIGS. FIG. 1 is a front view showing a stool collection container 500 used in a stool examination kit, FIG. 2 is a perspective view showing the structure of a stool collection rod 510 of the stool collection container 500, and FIG. 3 is a stool collection container. It is a longitudinal cross-sectional view which shows the structure of 500 container main bodies 520. FIG.

As shown in FIGS. 1 and 2, the stool collection container 500 has a rod-like stool collection bar 510 having a stool collection part 514 for collecting stool at the tip, and one end side as shown in FIGS. A stool collection bar insertion opening 521a of the stool collection bar 510, and a thin film portion 524 at the other end, and a container main body 520 for storing the stool collection bar 510 and storing a stool dissolution buffer W therein. ing.

Referring to FIG. 2, a stool collection rod 510 has an elongated rod shape as a whole, and a gripper 511 used when a user and an inspection operator handle the stool collection rod 510, and a main body shaft extending from the gripping unit 511. 512, a liquid storage shaft 513 extending from the main body shaft portion 512 and having an outer diameter smaller than that of the main body shaft portion 512, and the tip of the liquid storage shaft portion 513, and locks the stool when collecting stool A stool collection unit 514 is provided.

The stool collection rod 510 is an integrally molded product made of a resin material or the like, and may have an appropriate elasticity and hardness. As a material for the stool collection rod 510, a flexible resin such as polyethylene, polypropylene, polyester, ABS resin or the like is preferably used.

The entire length of the stool collection rod 510 is about 85 mm, the length of the grip portion 511 is about 15 mm, the length of the main body shaft portion 512 is about 40 mm, and the length of the liquid storage shaft portion 513 is about 30 mm. is there. The outer diameter of the grip portion 511 is about 9 mm, the outer diameter of the main body shaft portion 512 is about 5 mm, and the outer diameter of the liquid storage shaft portion 513 is about 3 mm.

Referring to FIG. 3, the container body 520 has a hollow cylindrical shape in which a stool collection rod insertion port 521a of the stool collection rod 510 is provided on one end side, and holds the body shaft portion 512 in a liquid-tight manner. While storing the 1st container part 521 and the buffer solution W for stool dissolution, it has the 2nd container part 522 in which the liquid storage axial part 513 is accommodated.

In the second container part 522, a thin film part 524 is provided inside an end of the second container part 522 opposite to the first container part 521, and a cap 530 (see FIG. 1) is screwed to the outside. A male screw 523 is provided.

The container body 520 is a resin material molded article, and a transparent or translucent soft flexible resin such as polyethylene, polypropylene, polyvinyl chloride, polybutadiene, polystyrene, or polyester is preferably used. The first container part 521 and the second container part 522 are formed of different products, and the second container part 522 is provided softer than the first container part 521.

The overall length of the container body 520 is about 105 mm, the length of the first container portion 521 is about 35 mm, and the length of the second container portion 522 is about 70 mm. The outer diameter (D1) of the container body 520 is about 10 mm.

(Inspection instrument 100)
Next, the structure of the inspection instrument 100 will be described with reference to FIGS. 4 is an overall perspective view from the front side of the inspection instrument 100, FIG. 5 is an overall perspective view from the back side of the inspection instrument 100, and FIG. 6 is a sectional view taken along line VI-VI in FIG. .

With reference to FIGS. 4 to 6, this inspection instrument 100 allows the container body 520 to be inserted along the axial direction without creating a gap with respect to the outer peripheral surface of the container body 520 of the stool collection container 500. A housing portion 103 that defines a cylindrical insertion space 104 and a main body portion 101 that is provided integrally with the housing portion 103 and has an inspection member housing space 111 therein are provided. In the inspection member accommodation space 111, a test strip 201 as a suspension inspection member is accommodated.

The insertion space 104 has an inner space having a cylindrical shape, and an inner diameter (D2) of the insertion space 104 is substantially the same as the outer diameter (D1) of the container body 520, and the container body 520 of the stool collection container 500 is provided. In the state where the insertion space 104 is mounted, there is no gap between the outer surface of the stool collection container 500 and the inner surface of the insertion space 104.

In the drawing on the back side of the main body 101, a rectangular window portion 110w is provided near the upper portion so that the test strip 201 accommodated in the inspection member accommodating space 111 can be seen.

Referring to FIG. 6, a needle 105 having a hollow path 106 with one end open and the other end communicating with the inspection member housing space 111 is provided inside the housing 103. In the figure, a filter housing portion 107 communicating with the hollow path 106 is provided at the lower end portion of the needle 105, and a filter 108 is disposed in the filter housing portion 107.

The filter housing portion 107 is open to the inspection member housing space 111. As a result, the hollow path 106 of the needle 105 communicates with the inspection member accommodation space 111.

In the inspection instrument 100 in the present embodiment, the main body 101 is provided in parallel to the direction in which the needle 105 extends. The test strip 201 has a strip shape, and one end 201 a of the test strip 201 is provided below the needle 105 so as to contact the filter 108. Further, the other end 201 b of the test strip 201 is accommodated in the inspection member accommodation space 111 so as to extend toward the distal end side of the needle 105.

Specifically, one end 201a of the test strip 201 is located on the opposite side to the other end side of the needle 105 with the filter 108 interposed therebetween, and the test strip 201 is bent into a substantially L shape in a side view, The other end 201 b of the test strip 201 is accommodated in the inspection member accommodation space 111 so as to extend toward the distal end side of the needle 105.

A cap 120 is provided at the lower end of the inspection instrument 100. In the illustration of the cap 120, a mounting bottom surface 120a is provided on the lower surface. The inspection instrument 100 can stand up with the mounting bottom surface 120a facing downward with respect to the mounting surface. Even in a state where the stool collection container 500 is mounted on the inspection instrument 100, the inspection instrument 100 and the stool collection container 500 can be erected. The cap 120 is not necessarily provided.

The inspection instrument 100 is a resin material molded product, and may have an appropriate elasticity and hardness. As a material of the inspection instrument 100, a transparent flexible resin such as polyethylene, polypropylene, polyester, ABS resin or the like is preferably used.

The inspection instrument 100 has a length (height) from the mounting bottom surface 120a of the main body 101 of about 75 mm, a width of about 12 mm, and a depth of about 5 mm. The length (height) of the accommodating portion 103 from the placement bottom surface 120 a is about 52 mm, the width is about 12 mm, and the depth is about 15 mm including the main body portion 101.

(Worn state)
Next, with reference to FIG. 7 and FIG. 8, mounting of the stool collection container 500 to the inspection instrument 100 will be described. FIG. 7 is a schematic view showing a state in which the stool collection container 500 is attached to the inspection instrument 100, and FIG. 8 is a longitudinal sectional view showing a state in which the stool collection container 500 is attached to the inspection instrument 100.

First, stool is collected using the stool collection rod 510 of the stool collection container 500, and the stool collection rod 510 to which the stool of the stool collection unit 514 is attached is accommodated in the stool collection container 500. As a result, a suspension in which the stool is dissolved is generated inside the stool collection container 500.

Next, as shown in FIG. 7, the cap 530 is removed from the tip of the stool collection container 500. Next, the stool collection container 500 is inserted from the distal end side into the insertion space 104 of the inspection instrument 100 along the direction of arrow A in the figure, and the stool collection container 500 is attached to the inspection instrument 100.

Referring to FIG. 8, by attaching stool collection container 500 to inspection instrument 100, needle 105 provided in inspection instrument 100 breaks through thin film portion 524 of stool collection container 500, and the suspension is in the middle. The air passage 106 passes through the filter 108 and penetrates the test strip 201. In the filter 108, stool that cannot be completely dissolved in the stool dissolution buffer is captured.

More specifically, when the needle 105 enters the inside of the stool collection container 500, the pressure inside the stool collection container 500 increases. As a result, the suspension flows out from the hollow path 106 to the filter housing portion, and further flows into the inspection member housing space 111.

For example, chromatographic paper is used for the test strip 201. When detecting fecal occult blood, a reagent that reacts with fecal occult blood is applied. When fecal occult blood is detected, the reagent application location of the test strip 201 is applied. Is discolored, and the discoloration of the test strip 201 can be confirmed in the window portion 110w.

As described above, according to the stool inspection kit in the present embodiment, by attaching the stool collection container 500 to the inspection instrument 100, the needle 105 provided on the inspection instrument 100 causes the thin film portion 524 of the stool collection container 500 to be attached. Break through and the suspension passes from the hollow passage 106 through the filter 108 and permeates the test strip 201. Thereby, the suspension in which the stool in the stool collection container 500 is dissolved is not splashed. By providing the filter 108 on the inspection instrument 100 side, it is not necessary to discard the first suspension in the stool collection container 500.

As a result, it is possible to provide a stool inspection kit having a structure in which a suspension in which stool is dissolved does not splash without causing labor for the inspection operator.

According to the stool inspection kit in the present embodiment, in the inspection instrument 100, the main body 101 is provided in parallel to the direction in which the needle 105 extends. Thereby, the inspection instrument 100 can be reduced in size. When it is not necessary to reduce the size, it is possible to adopt a configuration in which the main body 101 is provided in a direction intersecting the direction in which the needle 105 extends.

Furthermore, according to the stool inspection kit in the present embodiment, in the inspection instrument 100, the inspection instrument 100 is erected in both the mounted state and the non-mounted state of the stool collection container 500 in the insertion space 104. It can be in the state (vertical state). This makes it possible to reduce the space for placing the stool inspection kit during the inspection.

When it is not necessary to reduce the mounting space, it is not necessary to adopt a structure that allows the inspection instrument 100 to stand up.

(Other embodiments)
Other embodiments will be described with reference to FIGS. 9 to 12. 9 is an overall perspective view from the front side of the inspection instrument 100A according to another embodiment, FIG. 10 is an overall perspective view from the back side of the inspection instrument 100A according to another embodiment, and FIG. FIG. 12 is an overall perspective view showing a state in which the stool collection container 500 is attached to the inspection instrument 100A of the embodiment, and FIG. 12 is an overall perspective view from the front side of the inspection instrument of still another embodiment.

When checking the discoloration of the test strip 201 in the window part 110w of the inspection instrument, it is preferable to improve the visibility of the window part 110w. As shown in the inspection instrument 100A shown in FIGS. 9 and 10, a pair of leg walls 109 may be provided as mounting surfaces extending on the opposite side of the main body 101 of the housing 103.

When the pair of leg walls 109 is provided in this manner, as shown in FIG. 11, the state in which the stool collection container 500 is inserted into the insertion space 104 and the window portion 110w is the upper surface (horizontal state) is maintained. It is possible to keep. Even when the stool collection container 500 is not inserted into the insertion space 104, the stool collection container 500 can maintain the state in which the window 110w is the top surface.

Therefore, in a state where the stool collection container 500 is mounted on the inspection instrument 100, it can be left in the vertical state at the time of inspection (about 20 minutes), and then placed in the horizontal state for confirmation. Both inspection and determination confirmation can be performed in a horizontal state.

The form of the mounting surface is not limited to a pair of leg walls 109. For example, as shown in FIG. 12, the mounting surface 103a (for example, the outer surface shape on the opposite side of the main body 101 of the accommodating portion 103 is flat) The cross-sectional shape of the accommodating portion 103 may be a square).

Although the case where a circular cylindrical shape is adopted as the outer surface shape of the stool collection container 500 and the inner surface shape of the insertion space 104 has been described, it is not limited to this circular cylindrical shape. A polygonal cylindrical shape may be used as long as no gap is formed between the outer surface of the stool collection container 500 and the inner surface of the insertion space 104.

The essence of the present invention is that by attaching the stool collection container 500 to the inspection instrument 100, the needle 105 breaks through the thin film portion 524, and the suspension passes through the filter 108 from the hollow passage 106 without leaking to the outside. Any structure that penetrates the test strip 201 may be used. Accordingly, even when the outer shape of the stool collection container 500 is a circular cylindrical shape, and the inner shape of the insertion space 104 is a polygonal cylindrical shape that is in contact with the outer surface of the stool collection container 500. It doesn't matter.

As mentioned above, although embodiment of this invention was described, it should be thought that embodiment disclosed this time is an illustration and restrictive at no points. The scope of the present invention is defined by the terms of the claims, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.

100, 100A inspection instrument, 101 main body, 103 housing, 103a mounting surface, 104 insertion space, 105 needle, 106 hollow path, 107 filter housing, 108 filter, 109 leg wall, 110w window, 111 inspection member Storage space, 120, 530 cap, 120a bottom surface, 201 test strip, 500 stool collection container, 510 stool collection rod, 511 gripping part, 512 main body shaft part, 513 liquid storage shaft part, 514 stool collection part, 520 container main body 521 First container part, 521a Stool collection rod insertion port, 522 Second container part, 523 male screw, 524 thin film part, W stool dissolution buffer.

Claims

Collection of stool, put stool in stool dissolution buffer in container, hold stool-dissolved suspension, stool collection container, and inspection of stool using said lysis suspension A stool test kit comprising an instrument,
The stool collection container is
A rod-shaped stool collection rod having a stool collection part for collecting stool at the tip;
A stool collection rod insertion port on one end side and a thin film portion on the other end side, containing the stool collection rod, and a container body for storing the stool dissolution buffer therein,
The inspection instrument is:
A container defining a cylindrical insertion space in which the container body can be inserted along its axial direction;
A main body provided integrally with the housing, and having an inspection member housing space therein;
A suspension inspection member accommodated in the inspection member accommodation space;
A needle having a hollow path provided inside the housing portion, one end side being open and the other end side communicating with the inspection member housing space;
A filter housing provided between the inspection member housing space and the hollow path;
A filter housed in the filter housing portion,
By inserting the stool collection container containing the suspension in which stool is dissolved into the insertion space of the inspection instrument from its distal end side, and attaching the stool collection container to the inspection instrument, the needle becomes A stool inspection kit that breaks through a thin film portion and the suspension passes through the filter from the hollow path and penetrates into the suspension inspection member.
The main body is provided in parallel with the direction in which the needle extends,
The suspension inspection member has a strip shape,
One end of the suspension inspection member is provided so as to contact the filter,
The stool inspection kit according to claim 1, wherein the other end of the suspension inspection member is accommodated in the inspection member accommodation space so as to extend toward the distal end side of the needle.
The one end of the suspension inspection member is located on the opposite side of the other end side of the needle across the filter,
When the suspension inspection member is bent into a substantially L shape, the other end of the suspension inspection member is accommodated in the inspection member accommodation space so as to extend toward the distal end side of the needle. The stool test kit according to claim 2.
The stool inspection according to any one of claims 1 to 3, wherein the main body portion has a window portion capable of visually recognizing a part of the suspension inspection member accommodated in the inspection member accommodation space. kit.
The inspection instrument maintains the state in which the window portion is an upper surface in both the mounted state and the non-mounted state of the stool collection container in the insertion space. The stool inspection kit according to claim 4, further comprising a placement surface located on a side opposite to the portion.
The inspection instrument has a mounting bottom surface for raising the other end side of the needle as a lower side in both the mounted state and the non-mounted state of the stool collection container in the insertion space. Item 6. A stool test kit according to any one of Items 1 to 5.