JP4662891B2 - Stool collection container - Google Patents

Description

The present invention relates to a stool collection container for quantitatively collecting a stool specimen as a clinical test sample and diluting the stool specimen into a stool specimen dilution liquid.

Feces excreted from animals including humans are widely used as clinical test samples because they are very useful for diagnosis of various diseases and infection with pathogenic bacteria.
For the above diagnosis, it is necessary to collect stool quantitatively and dilute it into an appropriate liquid. Various stool collection containers have been reported in order to achieve this by simple and hygienic means and to enable sanitary storage and transportation after stool collection (for example, Patent Documents 1 to 6 and Non-Patent Documents). 1).

However, since there are various types of stool, such as high-fibre stool and watery stool, there are few stool collections depending on the stool characteristics, In some cases, the amount of stool collection required for various tests could not be secured sufficiently. In addition, due to differences in the properties of the stool to be examined, the stool collection varied widely among stool samples.

In particular, among various clinical tests using stool specimens, in the case of tests using antigen-antibody reactions against antigens contained in stool specimens, a certain amount of stool collection should be ensured regardless of the nature of the stool to be examined. Therefore, it is necessary to make the stool concentration of the stool specimen diluent constant. Such a stool collection container could not satisfy such a requirement. Therefore, it has been impossible to easily prepare a stool specimen diluent for use in a clinical test utilizing an antibody-antigen reaction using the above stool collection container.

Further, with the above stool collection container, it is difficult to perform the stool collection work in a short time, and there is a problem in terms of operability.
Japanese Patent No. 2740489 Japanese Patent No. 3242498 Japanese Patent No. 3219313 Japanese Patent Laid-Open No. 06-207935 Japanese Patent No. 3613876 JP 2004-317481 A Masahiko Wakasugi and five others, “Development of a stool collection kit for the Helicobacter pylori antigen detection kit“ Testmate H. pylori antigen EIA ”in stool”, Medicine and Pharmacy, 2004, Vol. 52, No. 3, p. 475-480

In view of the above-mentioned present situation, the present invention can secure a sufficient stool collection amount and reduce variations in the stool collection amount regardless of the nature of the stool to be examined, and also shortens the time required for stool collection. It is an object to provide a stool collection container that can be operated and has excellent operability.

The present inventors have found that the above problem can be solved by providing a concave portion in the stool collection portion in the vertical direction and applying flocking on the surface of the stool collection portion, and have completed the present invention.

That is, the present invention includes a container body having a reservoir for diluting a stool specimen, a dripping portion is provided at one end, and an opening end is provided at the other end;
A housing member provided with a thin film-like sealing film at one end and an opening end at the other end, and connected to the opening end of the container body at the end provided with the thin-film sealing film A receiving member to be
A stool collection rod having a rod-like portion, a stool collection portion formed at a tip portion of the rod-like portion and having a concave portion in the vertical direction and having a flocked surface, and a gripping portion, wherein the open end of the housing member The stool collection container is provided with a stool collection rod, the tip of which crushes the thin film-like sealing film by being inserted from the section, and the stool collection section is stored in the storage section of the container body.

In a preferred aspect of the stool collection container, the housing member has a female screw portion in the vicinity of the opening end,
The stool collection rod has a male thread portion between the rod-shaped portion and the grip portion,
The stool collection rod is inserted into the housing member while the male screw portion is screwed into the female screw portion.

In the suitable aspect of the said stool collection container, it has a cover member which can be attached or detached to the said dripping part of the said container main body further.
In a preferred embodiment of the stool collection container, the flocking is performed using short fibers having a length of 0.2 to 0.4 mm.

The stool collection container can be used for a clinical test utilizing an antibody-antigen reaction against an antigen contained in stool.
The stool collection container can be used for clinical tests for determining infection with Helicobacter pylori or Echinococcus using a stool specimen.

The stool collection container of the present invention can secure a sufficient stool collection amount and reduce variations in the stool collection amount regardless of the nature of the stool subject to inspection, and can shorten the time required for stool collection. Because it is possible, it has excellent operability. As described above, it is possible to improve the evaluation accuracy of clinical tests using collected stool specimens, particularly clinical tests using antibody-antigen reactions against antigens contained in stool.
The present invention is described in detail below.

The stool collection container of the present invention has a stool collection part 31 in the hollow interior (reservoir 12) of the container body 1 by inserting the container body 1, the storage member 2 connected to the container body 1, and the storage member 2. A stool collection rod 3 to be accommodated.

The container body 1 has a reservoir 12 for the stool specimen dilution liquid 11 inside. A drop portion 13 is provided at one end of the container body 1, and an open end portion 14 is provided at the other end.

The stool sample dilution liquid 11 is stored in the storage unit 12 before the stool collection, and after the stool collection, the stool sample dilution liquid 11 in which the stool sample is diluted is stored and the stool collection rod 3 The stool collection unit 31 is stored.

The dropping unit 13 is for easily taking out the stool sample dilution liquid 11 in which the stool sample is diluted after the stool collection from the storage unit 12 to the outside. Accordingly, the dropping unit 13 has holes through which liquid can be easily passed (preferably, by lightly pressurizing the container body 1), but the hole diameter is from the viewpoint of operability when taking out the diluted solution. What is necessary is just to determine suitably.

In order to take out the liquid mixed in the stool specimen dilution liquid 11 in which the toilet bowl has been diluted while taking out the liquid to the outside, the container body 1 has a filter in the vicinity of the dropping part 13 (that is, in the storage part 12). It is preferable to have.

The opening end 14 is for connection with the housing member 2, and for that purpose, a connecting recess 16 or a protrusion is provided on the inner surface of the container body 1 in the vicinity of the opening end. preferable.

Although it does not specifically limit as a form of the container main body 1, From a viewpoint of operativity, a cylindrical thing is preferable. Although it does not specifically limit as a material of the container main body 1, The transparent or translucent material is preferable so that the person who operates at the time of a stool collection or dilution liquid extraction can confirm the container main body 1 inside. Moreover, the material which has the softness | flexibility of the grade which a surface dents by lightly pressurizing by hand so that a dilution liquid can be easily taken out from the dripping part 13 after stool collection is preferable. Specific examples include synthetic resins such as polypropylene.

The housing member 2 is connected to the open end 14 of the container body 1, and the inside of the housing member 2 is hollow so that the stool collection rod 3 can be stored. A thin film-like sealing film 21 is provided at one end of the housing member 2, and an open end 22 is provided at the other end. The housing member 2 is connected to the open end 14 of the container body 1 at the end where the thin film-like sealing film 21 is provided.

The thin film-like sealing film 21 is for sealing the stool specimen dilution liquid 11 in the reservoir 12 of the container body 1 before the stool collection, and a part or the whole of the collected stool specimen is collected. Is diluted by the tip of the stool collection rod 3 when it is diluted into the stool specimen dilution liquid 11. However, even after crushing, the diluent is sealed in the reservoir 12 due to the presence of the stool collection rod 3.
Therefore, what is necessary is just to determine the thickness of the thin film-shaped sealing film 21 from a viewpoint which can be crushed by the front-end | tip by inserting a stool collection stick | rod.

In the housing member 2, a connecting convex portion 24 or a concave portion meshing with the connecting concave portion 16 or the convex portion is provided on the outer surface of the end portion having the thin film sealing film 21 so as to be connected to the container body 1. It is preferable. In order to connect the container main body 1 and the housing member 2, a screw mechanism can be used instead of the connecting concave portion or the convex portion.

The opening end 22 is for inserting the stool collection rod 3 therefrom.
It is preferable to have a female screw portion 23 inside the housing member 2 in the vicinity of the opening end 22. By providing the male screw portion 34 corresponding to this between the rod-shaped portion 33 and the grip portion 32 of the stool collection rod 3, the stool collection rod 3 can be inserted at an appropriate speed.

Although it does not specifically limit as a form of the accommodating member 2, A cylindrical thing is preferable from a viewpoint of operativity. Moreover, since the container main body 1 and the accommodating member 2 are united by connecting, it is preferable that the outer diameter of the container main body 1 and the outer diameter of the accommodating member 2 are the same.
The material of the housing member 2 is not particularly limited. The same material as the container body 1 may be used.

The stool collection rod 3 collects a stool sample from the stool to be examined. The stool collection rod has a rod-shaped portion 33, a stool collection portion 31 formed at the tip of the rod-shaped portion, and a grip portion 32. The tip of the stool collection rod 3, that is, the tip of the stool collection part 31 is preferably pointed so that the thin-film sealing film 21 can be crushed. When the stool collection rod 3 is inserted from the opening end 22 of the housing member 2, the tip of the stool collection rod 3 crushes the thin film-like sealing film 21, and the stool collection unit 31 is located inside the storage unit 12 of the container body 1. Stored in

The stool collection portion 31 is provided at the tip of the rod-shaped portion 33, and the stool collection portion 31 is provided with a recess (groove) 35 in the vertical direction, that is, in the insertion direction of the stool collection rod 3. This makes it easier to scrape the stool. By providing the concave portion 35 in the vertical direction, not in the horizontal direction, it becomes possible to reduce the variation in the amount of stool collection.

The shape of the recess 35 is not particularly limited, but from the viewpoint of the balance between ease of manufacture of the stool collection rod 3 and scraping performance, the front section of the stool collection unit 31 is formed in a cross shape as shown in FIG. It is preferable to do this.

It is preferable that the maximum diameter of the stool collection portion 31 (the diameter measured at a portion where the concave portion 35 is not provided) and the diameter of the rod-like portion 33 are substantially the same. As a result, the stool specimen adhering to the rod-shaped portion 33 can be left in the housing member 2 and the diluent can be prevented from leaking into the housing member 2 from the storage portion 12 of the container body 1. .

The maximum diameter of the stool collection portion 31 and the diameter of the rod-shaped portion 33 are not particularly limited and should be appropriately determined according to the required stool collection amount. For example, when assuming 20 mg as the stool collection amount, About 2 to 4 mm is preferable.

The maximum diameter of the stool collection portion 31 and the diameter of the rod-shaped portion 33 are preferably constant or continuously increased from the tip toward the grip portion 32. By increasing the diameter, the diluent leaks from the storage portion 12 of the container main body 1 into the housing member 2 through the crushing portion of the thin film-shaped sealing film 21 during and after the stool collection rod 3 is inserted. Can be prevented. In addition, by continuously increasing the diameter, it is possible to prevent extra stool specimens from being mixed into the stool specimen dilution liquid 11. If there is a discontinuous part in the increase in diameter, an uncontrollable amount of stool specimen may adhere to the part, which increases the possibility of variations in the amount of stool collected.

The depth of the concave portion 35 is not particularly limited, and should be determined appropriately in consideration of the required stool collection amount and the maximum diameter of the stool collection portion 31. For example, the maximum diameter of the stool collection portion 31 is 2 to 2. When it is about 4 mm, about 0.5-2 mm is good.
The length of the stool collection part 31 should be determined as appropriate according to the required stool collection amount, and is not particularly limited. However, considering the ease of operation, for example, about 0.5 to 3 cm is preferable. .

In the present invention, as the stool collection rod, a stool collection rod provided with a hair transplant 36 on the surface of the stool collection portion 31 provided with the recess 35 is used. As a result, a sufficient stool collection amount can be ensured regardless of the nature of the stool to be examined, and variations in the stool collection amount can be further reduced.
The flocking 36 may be applied to a part or the whole of the stool collection part 31, but is preferably applied to the entire stool collection part 31 including the recess 35 from the viewpoint of stool collection performance.

The material of the fiber used for flocking is not particularly limited, and examples include rayon, nylon, polyester, acrylic, polyclar, and carbon. Of these, nylon is preferable.
It does not specifically limit as the length of the fiber used for flocking, For example, 0.1-1.0 mm is mentioned. However, from the viewpoint of securing a certain amount of stool collection and reducing its variation, 0.1 to 0.8 mm is preferable, 0.15 to 0.6 mm is more preferable, 0.2 to 0.4 mm is further preferable, 0.25 to 0.35 mm is particularly preferable.
Although it does not specifically limit also as the thickness of the fiber used for flocking, For example, 0.5-4 denier is mentioned, Preferably it is 1-3 denier.

The flocking can be performed easily and uniformly by using electrostatic flocking. The electrostatic flocking process uses electrostatic attraction in a high-voltage electrostatic field, throws short fibers vertically onto a substrate that has been pre-applied with an adhesive, and then dries the adhesive layer to shorten the surface of the substrate. The fiber is fixed. In the present invention, electrostatic flocking can be performed by a conventional method.

The stool collection rod 3 has a grip 32 on the opposite side of the stool collection unit 31. A person using the stool collection rod 3 performs stool collection by holding the grip portion 32. The surface of the grip portion 32 may be subjected to appropriate surface processing so that it can be easily held.
After the stool collection, the stool collection rod 3 is inserted into the container body 1 and the housing member 2 as shown in FIG. The diameter and the diameter of the housing member 2 are preferably substantially the same.
It is preferable that the opening end portion 22 of the housing member 2 is closed by the grip portion 32.

In a preferred embodiment of the present invention, the stool collection rod 3 is located at the stool collection portion 31 located at one end, the rod-like portion 33, the male screw portion 34 screwed with the female screw portion 23 inside the housing member 2, and the other end. It consists of a gripping part 32. As shown in FIG. 5, the stool collection part 31, the rod-shaped part 33, the external thread part 34, and the holding part 32 exist in this description order.
The diameter of the male thread portion 34 is preferably larger than the maximum diameter of the stool collection portion 31 and the diameter of the rod-shaped portion 33, and the diameter of the grip portion 32 is preferably further increased.

A person who uses the stool collection container of the present invention first performs stool collection using the stool collection rod 3, and in this case, a stool specimen is attached around the stool collection unit 31. In the present invention, since the concave portion 35 is provided in the vertical direction, a certain amount of stool specimen can be easily attached. Thereafter, the stool collection rod 3 is inserted into the opening end 22 of the housing member 2 with the stool collection portion 31 at the top, and then the stool collection rod 3 is advanced into the housing member 2 as shown in FIG. The thin film-like sealing film 21 of the housing member 2 is crushed by the tip of the stool collection rod 3 while the female screw portion 23 inside the housing member 2 and the male screw portion 34 of the stool collection rod 3 are screwed together.

Further, when the stool collection rod 3 is advanced while the female screw portion 23 and the male screw portion 34 are screwed together, the entire stool collection portion 31 is stored inside the storage portion 12 of the container body 1. During this time, surplus stool specimen adhering to the portion exceeding the maximum diameter of the stool collection portion 31 is left in the housing member 2.

Further, the stool collection rod 3 is advanced and the rod-shaped portion 33 is passed through the crushing portion of the thin film-like sealing film 21, so that the stool specimen surplus adhering to the rod-shaped portion 33 is also left in the housing member 2. . As described above, only a certain amount of stool specimen attached to the stool collection unit 31 is inserted into the storage unit 12 of the container body 1. By the above operation, a stool specimen diluent having a constant concentration can be easily prepared.

Eventually, the rod-shaped part 33 completely seals the crushing portion of the thin-film sealing film 21, so that the container body 1 is stored in a state in which the diluent is sealed inside the storage part 12 of the container body 1. The stool collection container can be stored and transported in a sanitary manner without the diluent leaking from the portion 12 into the housing member 2.

The material of the stool collection rod 3 is not particularly limited, but a material having a hardness suitable for being held by a human is suitable, and examples thereof include synthetic resins such as ABS.

The stool collection container of the present invention preferably further includes a detachable lid member 4 that seals the dropping portion 13 of the container body 1 in addition to the container body 1, the housing member 2, and the stool collection rod 3. Thereby, leakage of the stool specimen dilution liquid 11 accommodated in the reservoir 12 of the container body 1 can be prevented.

The method of attaching the lid member 4 to the container body 1 is not particularly limited as long as the dripping portion 13 of the container body 1 can be sealed. For example, the male screw portion 17 is provided on the outer surface of the end near the dripping portion 13. It is preferable that the lid member 4 has a female screw portion 41.
Before and after the stool collection, the lid member 4 is held in a state of being attached to the container main body 1, and the lid member 4 may be separated from the container main body 1 when taking out the stool specimen diluent from the container main body 1.

FIG. 1 is a side sectional view (partial side view) showing an embodiment of a stool collection container of the present invention. Here, only the stool collection rod 3 is shown in a side view, and the other members (the container body 1, the housing member 2, and the lid member 4) are shown in a side sectional view. The container main body 1 and the housing member 2 are in a state of being connected via a connecting concave portion 16 and a connecting convex portion 24, and the lid member 4 and the container main body 1 are in a state of being connected via a female screw portion 41 and a male screw portion 17. . About the stool collection stick 3, the front-end | tip has shown the state before crushing the thin film-like sealing film | membrane 21. FIG.

FIG. 2 shows a state in which the stool collection rod is completely inserted in the stool collection container of FIG. A state in which the stool specimen dilution liquid 11 is stored in the storage unit 12 is shown. The stool collection container of the present invention takes such a form after stool collection and is stored and transported hygienically.

3 to 5 show a side sectional view of the container body 1 in the stool collection container of FIG. 1, a side sectional view of the housing member 2, and a side view of the stool collection rod 3, respectively. In addition, the stool collection part 31 of FIG. 5 has shown the case where four recessed parts 35 are provided in the vertical direction, ie, the insertion direction of the stool collection rod 3, as shown in FIG. For simplicity, however, the flocking 36 is omitted in FIG. 5, but flocking is applied to the entire stool collection portion 31 provided with the recess 35.

FIG. 6 is a front sectional view of the stool collection portion 31 according to a preferred embodiment of the present invention, in which four recesses 35 are provided so as to have a substantially cross shape. The flocks 36 are applied to the entire surface including the recesses 35.
FIG. 7 is a side sectional view of the lid member 4 in the stool collection container of FIG.

The stool collection container of the present invention can sufficiently secure the stool collection amount necessary for various tests, can reduce variations in the stool collection amount, and can shorten the time required for stool collection. Since it is excellent in operability, it can be used for various tests using a stool specimen. By appropriately adjusting the length and diameter of the stool collection portion 31, the length and depth of the longitudinal recess 35, the volume of the stool specimen dilution liquid, and the like, the stool collection amount and stool dilution concentration according to the type of test to be applied Can be achieved.

In particular, clinical tests using antibody-antigen reactions to antigens contained in stool strongly require that the stool concentration of the stool specimen dilution be constant (that is, there is little variation in the amount of stool collected between stool specimens). Therefore, the stool collection container of the present invention having extremely excellent performance in this respect can be suitably applied.

Especially, the stool collection container of this invention can be used conveniently in the clinical test | inspection which determines the infection to Helicobacter pylori or Echinococcus using the stool specimen. The test can be achieved by detecting Helicobacter pylori antigen or Echinococcus tapeworm antigen in the stool specimen.

Specific examples of the clinical test for determining infection with Helicobacter pylori include a clinical test for detecting native catalase of Helicobacter pylori present in stool as an antigen. In this test, an anti-Helicobacter pylori monoclonal antibody or an anti-Helicobacter pylori polyclonal antibody can be used to detect the catalase. In particular, the former is superior in specificity as compared with the latter, and the test sensitivity is good.

The antigen detection method in the above test is not particularly limited. For example, the ELISA method (for example, “Testmate Pylori Antigen EIA (registered trademark)” manufactured by Wakamoto Pharmaceutical Co., Ltd.) or the immunochromatography method (for example, Wakamoto Pharmaceutical) Examples include those based on “Testmate Rapid Pylori Antigen (registered trademark)” of a corporation.

In regard to clinical tests for determining infection with Echinococcus spp., In order to detect Echinococcus spp. Genus tapeworm polyclonal antibodies can be used. In particular, the former is superior in specificity compared to the latter, and can produce a reagent with good test sensitivity. Although it does not specifically limit as a detection method of the antigen in the said test | inspection, For example, what was based on ELISA method or immunochromatography method can be mentioned.

Below, the test example which evaluated the performance using the stool collection stick (FIG. 5) and stool collection container (FIG. 1) in one Embodiment of this invention shown in FIG. 1 is described. In the following, in order to evaluate the performance of the stool collection container, “Testmate Pylori Antigen EIA (registered trademark)” (hereinafter also referred to as “TPK”), which is a fecal Helicobacter pylori antigen detection reagent manufactured by Wakamoto Pharmaceutical Co., Ltd., In addition, “Testmate Rapid Pylori Antigen (registered trademark)” (hereinafter also referred to as “RPK”) was used.

Test example 1
Measurement of stool weight In order to conduct an accurate inspection with TPK and RPK, a stool weight of 10 mg or more is required.
5 is a stool collection rod in which electrostatic flocking is applied to the stool collection portion 31 of the present invention, and three types of short fibers used for flocking are different (length of short fibers). 0.3mm, 0.4mm and 0.6mm, the diameter of each fiber is 1.7 denier, each fiber is made of nylon), and the same stool collection rod except that the stool collection part 31 is not flocked The stool was collected from 71 specimens and the stool weight was measured. The results are shown in FIG. 8, and the results of calculating the average stool weight, standard deviation and coefficient of variation based on this are shown in Table 1.

The non-planted stool bar had an average stool weight of 19 mg and a large variation. Some of the stools that were difficult to collect had a stool weight of less than 10 mg.
On the other hand, for the three types of flocking stool sticks, the average stool collection weight increased and the variation was small. In particular, when the length of the short fiber was 0.3 mm, the variation was the smallest and the minimum stool collection weight exceeded 20 mg, and the stool collection performance was the best.

Test example 2
When collecting a stool in Test Example 1 for stool collection time, the stool collection rod 31 shown in FIG. 5 and the non-flocked stool collection rod 31 subjected to electrostatic flocking processing with a short fiber having a length of 0.3 mm on the stool collection portion 31 were collected. The time required for the stool was measured. Table 2 shows the result of calculating the average value of the time required to collect one specimen.
A: Average time required for stool collection for 10 specimens of watery stool B: Average value of time required for stool collection for 10 specimens of high fiber stool C: Average time required for stool collection for 51 specimens of normal stool Value D: Average value of time taken for stool collection for all 71 samples

Even if it is a skilled inspection worker, stool collection is better when using a flocking stool bar than when using a non-flocking stool bar, regardless of whether it is watery stool, high fiber stool or normal stool. The time was reduced by about 15%. The improvement in the accuracy of the stool collection weight is as described in Test Example 1.

Test example 3
Evaluation by TPK (Testmate H. pylori antigen EIA) (1) From 6 samples (2 watery stool samples H116, H1091, 4 normal stool samples H57, H594, H1078, H1124) derived from a person positive for Helicobacter pylori infection The stool was collected using the same stool collection container except that the stool collection container of the present invention provided with any one of the three types of flocking stool collection rods used in 1 or the stool collection part 31 was not flocked, and TPK Absorbance was measured by. The result is shown in FIG. In TPK, a case where the absorbance is 0.1 or more is determined as positive.

In the case of a non-flocked stool stick, the absorbance was less than 0.1 and was falsely determined to be negative. However, in any of the three types of flocked stool sticks, the absorbance was 0.1 or more and all could be judged positive. It was.

(2) From 15 specimens derived from Helicobacter pylori infection negative persons, the stool collection container of the present invention provided with any of the three types of stool collection stool used in Test Example 1 or the stool collection part 31 was transplanted. The stool was collected using the same stool collection container except for the points not measured, and the absorbance was measured by TPK. The result is shown in FIG.

In any of the three types of flocking stool sticks, the absorbance was less than 0.1, similar to that of the non-flocking stool sticks, and all were determined to be negative.

Test example 4
Evaluation with RPK (Testmate Rapid Pylori Antigen) Eight specimens derived from persons with positive infection with Helicobacter pylori (two watery stools H1091, H1104, high fiber stool H1067, five normal stool samples H790, H864, H886, H912, H913) ) From the stool collection container of the present invention provided with any of the three types of flocking stool collection rods used in Test Example 1, or the same stool collection container except that the stool collection unit 31 is not flocked. The stool was collected and examined with RPK. The results are shown in Table 3. In Table 3, + indicates positive and-indicates negative.

Although all of the non-flocked stool bars were falsely determined to be negative, all of the three types of flocked stool bars could be determined to be positive.

Test Example 5
The antigen solution for management of various concentrations diluted with the test specimen dilution solution using the simulated watery stool is regarded as a simulated stool of the watery stool, and from this, the stool collection part 31 used in Test Example 1 has a length of 0.3 mm. Samples are collected using a stool collection container provided with the stool collection rod of FIG. 5 subjected to electrostatic flocking processing with short fibers, or the same stool collection container except that the stool collection unit 31 is not flocked, and TPK Absorbance was measured by. The used stool collection container was designed so that a sample collected about 20 mg was diluted 50 times with 1 mL of sample diluent.
Table 4 shows the obtained results.

From Table 4, it can be seen that in the case of the flocking stool rod, the sensitivity was improved about twice as compared with the case of the non-flocking stool rod.
In particular, in the case of a specimen having an antigen concentration of 940 ng / mL, the absorbance was 0.067 in the case of a non-planted stool collection bar, but the absorbance was 0.067, but the absorbance was in the case of a hair transplantation stool collection stick. It was judged positive at 0.137.

By using a stool collection rod having a stool collection part having a convex part in the vertical direction and flocking on the surface, 20 mg or more, which is twice the minimum stool collection weight required for TPK and RPK, of 10 mg is collected. In addition, it was possible to suppress the variation in the amount of stool collection compared to the non-flocked stool collection rod.
Furthermore, with the flocking stool, the feces can be collected in a shorter time than the non-flocking stool, and the operability is improved from the characteristics of any of the watery stool, high-fiber stool, and normal stool.

Reflecting the above, the test results (sensitivity) with TPK and RPK were improved, and positive specimens that could not be judged positive with non-flocked stool collection sticks could be judged positive with flocking stool collection sticks. On the other hand, the negative specimen was not erroneously determined to be positive by using a flocking stool stick.
In addition, using a flocking stool stick, it was possible to collect stool that matched the sensitivity of TPK even with watery stool that was difficult to collect.

Test Example 6
Measurement of stool weight using canine stool Using a stool collection rod that was subjected to electrostatic flocking processing with a short fiber having a length of 0.3 mm used in Test Example 1 or a stool collection rod that was not subjected to flocking, dog stool Feces were collected from 22 specimens and the weight of the feces was measured. The results of calculating the average stool collection weight from the results and the minimum stool collection weight are shown in Table 5.

By using the flocking stool stick, the average stool collection weight increased more than 1.8 times compared to the case of using the non-flocking stool stick. Furthermore, by using a flocking stool rod, a result that the minimum stool weight exceeded 30 mg was obtained.

Test Example 7
Evaluation using an Echinococcus tapeworm antigen detection reagent using canine feces From 22 dog feces collected in Test Example 6, electrostatic flocking with a 0.3 mm-long short fiber is placed on the stool collection part 31 used in Test Example 1 Samples were collected using the same stool collection container except that the processed stool collection rod shown in FIG. 5 or the stool collection part 31 was not flocked, and based on the immunochromatography method The test was performed using the Echinococcus tapeworm antigen detection reagent. The used stool collection container was designed so that a sample collected about 20 mg was diluted 50 times with 1 mL of sample diluent.
The results obtained are shown in Table 6. In Table 6, + indicates positive and-indicates negative.

By using a flocking stool stick, the sensitivity was improved compared to the case of using a non-flocked stool stick, and two specimens that could not be determined to be positive with a non-flocking stool stick (these specimens are the conventional ones). (It was determined as positive by the ELISA method) could be determined as positive.

Test Example 8
Evaluation with Echinococcus faecium antigen detection reagent using simulated watery stool The antigen solution for management diluted with the sample dilution solution is considered to be a simulated stool of watery stool. went.
The results obtained are shown in Table 7.

The non-planted stool bar had a detection limit of 5 ng / mL, whereas the non-planted stool bar had a detection limit of 2.5 ng / mL. That is, it was found that the minimum measurement sensitivity was improved twice in the case of a flocking stool stick compared to the case of a non-flocking stool stick.

The stool collection container of the present invention can secure a sufficient stool collection amount and reduce variations in the stool collection amount regardless of the nature of the stool subject to inspection, and can shorten the time required for stool collection. And excellent in operability. Therefore, it is a very useful stool collection container in various clinical tests using stool specimens, particularly in tests using antibody antigen reaction against antigens contained in stool.

Side surface sectional drawing (partial side view) which shows one Embodiment of the stool collection container of this invention Side surface sectional drawing (partial side view) which shows the state which inserted the stool collection rod completely in the stool collection container shown in FIG. Side surface sectional drawing of the container main body in the stool collection container shown in FIG. Side surface sectional drawing of the accommodating member in the stool collection container shown in FIG. Side view of the stool collection rod in the stool collection container shown in FIG. Front sectional view of the stool collection part of the stool collection rod in the stool collection container shown in FIG. Side surface sectional drawing of the cover member in the stool collection container shown in FIG. Distribution chart showing stool weight measurement results in Test Example 1 Distribution diagram showing absorbance measurement results with TPK in Test Example 3 (1) Distribution diagram showing absorbance measurement results with TPK in Test Example 3 (2)

Explanation of symbols

1: Container body 2: Housing member 3: Stool collection rod 4: Lid member 11: Stool specimen dilution liquid 12: Reservoir 13: Dropping unit 14: Opening end 16: Concave recess 17: Male screw 21: Thin film Sealing film 22: Open end 23: Female thread part 24: Convex convex part 31: Stool collection part 32: Grasping part 33: Rod-shaped part 34: Male thread part 35: Concave part 36: Flocking 41: Female thread part

Claims (6)

A container body having a reservoir for liquid for diluting stool specimen, provided with a dropping part at one end and an opening end at the other end;
A housing member provided with a thin film-like sealing film at one end and an opening end at the other end, and connected to the opening end of the container body at the end provided with the thin-film sealing film A receiving member to be
A stool collection rod having a rod-like portion, a stool collection portion formed in a tip portion of the rod-like portion, having a concave portion in the vertical direction and having a flocked surface, and a gripping portion, wherein the opening end of the housing member By inserting from the part, the tip crushes the thin film-like sealing film, and the stool collection rod is stored in the storage part of the container body,
A stool collection container. The housing member has a female screw portion in the vicinity of the opening end,
The stool collection rod has a male screw portion between the rod-shaped portion and the grip portion,
The stool collection container according to claim 1, wherein the stool collection rod is inserted into the housing member while the male screw part is screwed into the female screw part. Furthermore, the stool collection container of Claim 1 or 2 which has a cover member which can be attached or detached to the said dripping part of the said container main body. The stool collection container according to any one of claims 1 to 3, wherein the flocking is applied using short fibers having a length of 0.2 to 0.4 mm. The stool collection container according to any one of claims 1 to 4, which is used for a clinical test utilizing an antibody-antigen reaction against an antigen contained in stool. The stool collection container according to any one of claims 1 to 5, wherein the stool collection container is used in a clinical test for determining infection with Helicobacter pylori or Echinococcus using a stool specimen.

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