JP2013228235A - Inspection kit - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a compact inspection kit capable of efficiently and safely treating an analyte which may contain a virus, bacteria, etc., and an instrument having the analyte stuck so that the analyte is neither brought into contact with a handling person nor exposed to an external environment.SOLUTION: An inspection kit includes an analyte collector for collecting an analyte, and an analyte adjustment container which has a first opening for inserting the analyte collector on one end side, and contains an adjusting liquid for dispersing or dissolving the collected analyte inside. The analyte collector includes a shaft part, an analyte collection part provided to one lengthwise end of the shaft part in one body, and a cap part provided to the other lengthwise end of the shaft part in one body. The analyte adjustment container is configured to accommodate the analyte collection part and shaft part inside, and the cap part is configured to seal the first opening part of the analyte adjustment container so as to keep hermetic the analyte adjustment container accommodating at least the analyte collection part and shaft part.

Description

  The present invention relates to a test kit used for testing a specimen such as nasal discharge, pharyngeal fluid, sputum or urine. Specifically, the present invention relates to a test kit that can prevent contamination and infection by a sample and can easily test the sample.

  In recent years, many clinical tests using immunochromatography have been adopted in clinical tests for diagnosing the health condition of patients. The immunochromatography method (1) does not require a special measuring machine and can be judged visually, (2) the time required for the inspection is only a few tens of minutes, and (3) the operation for the inspection is simple. It has excellent features such as not requiring special technology. Due to these characteristics, the immunochromatography method is mainly used for virus inspection such as influenza and bacterial infection inspection in the medical field, and enables rapid treatment start and accurate treatment after inspection diagnosis. In addition, due to the above features, pregnancy test drugs using immunochromatography are widely sold as OTC test drugs in pharmacies and drug stores, and self-checking of pregnancy status is widely performed.

  Virus inspection and bacterial infection inspection by immunochromatography are mainly performed on specimens collected by wiping the patient's nasal cavity, pharynx or conjunctiva with a specimen collection tool such as a cotton swab or swab. The collected specimen is dispersed or dissolved by immersing it in a specimen preparation solution, and is prepared as a developing solution for immunochromatography measurement. At that time, if the sample contains highly infectious virus, bacteria, etc., infection caused by contact of the sample collection tool or sample adjustment solution used for the test with the operator, sample adjustment solution, etc. There is a risk of microbial contamination due to leakage into the environment. For this reason, it is necessary to take measures to prevent infection and microbial contamination not only during the examination but also until the specimen collection tool and specimen adjustment liquid after the examination are discarded.

  Therefore, the present applicant has proposed a test kit that can perform a test by processing a sample without touching the handler (Patent Documents 1 and 2).

  The test kit proposed in Patent Document 1 includes a sample collection jig, a container body in which a sample extract is housed, and an opening of the container body while the sample collection jig is housed in the container body without being bent. And a sealing lid with a specimen collecting jig housing function. Therefore, in this test kit, after the sample collected by the sample collecting jig is transferred to the sample extract, the sample extract is placed in the space formed by the container body and the sealing lid with the sample collecting jig accommodating function. And used specimen collection jigs can be sealed.

  In addition, the inspection kit proposed in Patent Document 2 includes a small-diameter portion that can be deformed by applying stress, and a large-diameter portion having rigidity that does not change the dimensions even when the small-diameter portion is deformed. A sample collection jig, a container main body in which the sample extract is accommodated, and an opening sealing lid for sealing the opening of the container main body. Therefore, in this test kit, after the sample collected by the sample collection jig is transferred to the sample extract, the small diameter part of the sample collection jig is bent so that the entire length of the sample collection jig is shortened. The specimen extract and the used specimen collection jig are sealed in the space formed by the specimen container body and the opening sealing lid. Can do.

Japanese Patent No. 4801030 JP 2012-37501 A

  However, in the test kit described in Patent Document 1, in order to prevent the sample extract from spilling when the used sample collection jig is accommodated in the container body and sealed, the container body and the sample collection jig are used. Is maintained in a substantially vertical state and must be sealed with a separate sealing lid with a specimen collecting jig housing function, which is troublesome. In addition, generally used specimen collection jigs are prepared so that they can be inserted through the patient's nostrils and mouth to wipe the nasal cavity and pharynx. When the jig is accommodated in the container body and the sealing lid with the specimen collecting jig accommodation function is applied, the overall size becomes large, and thus the downsizing of the test kit has been desired.

  Furthermore, in the test kit described in Patent Document 2, when the used specimen collecting jig is accommodated in the container body and sealed, the container body is maintained in a substantially vertical state, and the specimen collecting jig is stored. The small-diameter portion is bent and accommodated while being pushed into the inner side of the container body. When the container body is sealed, it is necessary to insert a separate opening / sealing lid into the opening of the container body and seal it, which is troublesome. Furthermore, if the specimen collection jig once folded and stored may come out of the container body again, there is a risk of infection, so the specimen collection jig is securely folded and stored in a sealed state. In order to do this, there has been a demand to seal the specimen collecting jig while pushing it in without taking an eye off the contained specimen collecting jig.

  On the other hand, if a person can perform a virus test such as influenza or a test for bacterial infection at home, school, workplace, etc., like a pregnancy test drug sold at pharmacies, etc., a quick and accurate treatment is possible. There is a possibility. Therefore, an OTC test agent capable of performing a virus test or a bacterial infection test safely and easily is also demanded.

  The object of the present invention has been devised in view of the above points so that a sample that may contain a virus, a bacterium, or the like does not come into contact with the handler or be exposed to the external environment. It is an object of the present invention to provide a small test kit that can safely and efficiently process a sample and a device to which the sample is attached.

  The test kit of the present invention has a sample collecting tool for collecting a sample and a first opening for inserting the sample collecting tool on one end side, and disperses or dissolves the collected sample. And a sample adjustment container in which the adjustment liquid is contained. The sample collecting tool includes a shaft portion, a sample collecting portion provided integrally at one end in the longitudinal direction of the shaft portion, and a cap portion provided integrally at the other end in the longitudinal direction of the shaft portion. . The sample adjustment container is configured to accommodate the sample collection portion and the shaft portion therein, and the cap portion includes at least a sample adjustment container containing the sample collection portion and the shaft portion. The first opening is configured to be sealed.

  The cap part integrally provided at the other end in the longitudinal direction of the shaft part of the sample collection tool is a first opening of the sample adjustment container for sealing the sample collection part and the sample adjustment container containing the shaft part. Is configured to seal. When performing the test, grasp the cap part of the sample collection tool, insert part of the sample collection part and shaft part of the sample collection tool into the patient's nostril and mouth, etc., and wipe the nasal cavity and pharynx etc. with the sample collection part Collect samples. While inserting the sample collection portion for holding the collected sample and the shaft portion to which the sample may be attached from the first opening of the sample adjustment container and accommodating them inside the sample adjustment container, The specimen opening can be sealed by sealing the first opening as it is with the gripping cap. In this way, it is possible to easily and quickly seal the portion of the used sample collection tool to which the sample may adhere and the sample adjustment liquid. Therefore, it is possible to efficiently and safely handle a specimen that is not desired to come into contact with the handler or to be exposed to the external environment and a device to which the specimen is attached. Specifically, the handling of specimens in the examination room or ward where specimens are collected is efficient and safer, as well as the parts where the specimens of used specimen collectors may adhere By ensuring that the sample adjustment liquid is sealed inside the sample adjustment container, the sample can be stored in the external environment in the process of transporting it to the laboratory or laboratory, and in the process of disposal after testing in the laboratory or laboratory. It can be handled and processed safely without touching the operator. In addition, since specimens and the like can be handled safely and efficiently, the examination can be performed at school or at home, and can also be used as an OTC test agent. Since the sample collection part of the sample collection tool is immersed in the adjustment liquid stored in the sample adjustment container by accommodating the sample collection part in the sample adjustment container, the collected sample is dispersed or dissolved in the adjustment liquid. A specimen can be suitably prepared.

  The cap portion includes at least one cap portion side engaging means disposed along the circumferential direction on the inner wall or the outer wall thereof, and the specimen adjustment container is disposed on the outer wall or the inner wall in the vicinity of the first opening portion. It is preferable to include an opening side engaging means that engages with the cap part side engaging means arranged along the circumferential direction. The sample collecting tool is provided with a cap portion side engaging means, and the opening portion side engaging means that engages with the cap portion side engaging means is provided in the sample adjusting container, whereby the cap portion of the sample collecting tool is attached to the sample adjusting container. It can be reliably fixed and sealed in the first opening. Therefore, the specimen and the instrument to which the specimen is attached can be processed more safely. Further, even if the entire specimen adjustment container is swung or shaken, the adjustment liquid does not leak, and the sample and the adjustment liquid can be sufficiently mixed and processed.

  The sample adjustment container is configured such that the axial length thereof is shorter than the total length of the axis of the sample collection tool and the length of the sample collection unit. It is also preferable to have at least one notch for allowing the shaft portion to be divided in the axial direction. Since the shaft portion is divided in the axial direction at the position of the notch provided in the shaft portion, the length of the shaft portion of the sample collecting tool can be substantially shortened. Therefore, the axial length of the specimen adjustment container that houses the specimen collection tool can be shortened, and the test kit can be downsized.

  The shaft portion of the sample collecting tool has a flexible portion that deforms when stress is applied on the sample collecting portion side, and has a base portion that is more rigid than the flexible portion on the cap portion side from the flexible portion. It is also preferable. When the shaft portion of the sample collection tool is accommodated inside the sample adjustment container, the flexible portion of the shaft portion can be deformed and bent or bent inside the sample adjustment container. Can be substantially shortened. Therefore, the axial length of the specimen adjustment container that houses the specimen collection tool can be shortened, and the test kit can be downsized. In addition, since the base part of the shaft part of the sample collection tool is more rigid than the flexible part, it is possible to collect the sample suitably without impairing good operability during sample collection.

  It is also preferable that the sample adjustment container includes a first lid that seals the first opening to seal the sample adjustment container and is removable for inserting the sample collection tool. Since the sample preparation container containing the preparation liquid is sealed with the first lid in advance, the preparation liquid is not spilled to the outside, and the preparation liquid is prevented from being contaminated with substances other than the test target. can do. Then, only by removing the first lid to insert the sample collection tool, the sample adjustment container is opened, so that the sample collection tool from which the sample has been collected is immediately accommodated in the sample adjustment container, and the sample collection tool The first opening can be sealed and sealed with the cap portion.

  A second opening for discharging the adjustment liquid containing the sample dispersed or dissolved in the adjustment liquid to the outside is provided on the other end side of the sample adjustment container. It is also preferable to include a second lid for sealing provided in the vicinity of the second opening for sealing. Since the adjustment liquid containing the sample can be discharged from the second opening of the sample adjustment container, the inspection can be performed efficiently and easily.

  In order to filter the adjustment liquid containing the specimen dispersed or dissolved in the adjustment liquid, the apparatus further includes a filter device fitted in the second opening, and the second lid body includes the second opening of the filter device. It is also preferable that it is configured to be opened by fitting to the part. By simply fitting the filter device to the second lid provided in the sample adjustment container, the second opening can be opened and the adjustment liquid can be filtered, thus making the inspection more efficient and simple. It can be performed.

According to the present invention, a test kit having the following excellent effects can be provided.
(1) A sample collection unit for holding a collected sample and a shaft part to which the sample may be attached are inserted from the first opening of the sample adjustment container into the sample adjustment container. By sealing the first opening as it is with the gripping cap, the specimen adjustment container can be easily and quickly sealed. It is possible to efficiently and safely process and test a specimen that is not desired to be in contact with the handler or exposed to the external environment and a device to which the specimen is attached.
(2) The above-described effects can be obtained, and the inspection kit can be downsized.

It is the front view of the sample collection tool of the test kit which concerns on 1st embodiment of this invention, and the axial sectional view of a sample adjustment container, a container opening tool, and a sealing lid. 2A is an enlarged front view of an AB portion of a specimen collection tool and FIG. 2B is an enlarged axial sectional view of a CD portion of a specimen adjustment container in the test kit shown in FIG. In the test kit shown in FIG. 1, (A) the sample collection part and the shaft part of the sample collection tool are housed inside the sample adjustment container, and the first opening of the sample adjustment container is sealed with the cap part of the sample collection tool. It is explanatory drawing which shows the state stopped | stopped, and (B) It is an expansion explanatory drawing of the EF part of FIG. 3 (A). It is explanatory drawing which shows roughly the use condition of the test kit shown in FIG. 1, Comprising: (A) The state which inserted the sample collection part and axial part of the sample collection tool into the sample adjustment container, (B) Sample The sample collection portion and the shaft portion of the collection tool are further pushed into the sample adjustment container, and the flexible portion of the shaft portion is bent in a loop shape. (C) The shaft portion of the sample collection tool is notched. It is explanatory drawing which shows each the state which folded at the position and divided | segmented the axial part, respectively. In the test kit shown in FIG. 1, the sample collection part and the shaft part of the sample collection tool are housed, and the filter device is attached to the sample adjustment container in which the first opening is sealed with the cap part of the sample collection tool. It is explanatory drawing which shows schematically the state which formed the through-hole in the 2nd opening part (adjustment liquid discharge part), and discharged | emitted the sample adjustment liquid. It is the front view of the sample collection tool of the test kit which concerns on 2nd embodiment of this invention, and the axial sectional view of a sample adjustment container, a container opening tool, and a sealing lid. It is explanatory drawing which shows roughly the use condition of the test kit shown in FIG. 6, Comprising: (A) The state which inserted the sample collection part and axial part of the sample collection tool into the sample adjustment container, (B) Sample The shaft part of the collecting tool is folded at the position where the notch on the sample collecting part side is cut and the shaft part is divided. (C) The shaft part of the sample collecting tool is at the position where the notch on the cap part side is cut. It is explanatory drawing which shows each the state which folded and divided | segmented the axial part roughly. In the test kit shown in FIG. 6, the sample collection part and the shaft part of the sample collection tool are housed in the sample adjustment container, and the first opening of the sample adjustment container is sealed with the cap part of the sample collection tool It is explanatory drawing which shows this roughly.

  Hereinafter, a first embodiment of the present invention will be described.

  As shown in FIG. 1, the test kit 1 according to the first embodiment of the present invention includes a sample collection tool 2, a sample adjustment container 6, a filter device 8, and a sealing lid 9. In addition, although the test kit according to the present embodiment shows a test kit used for influenza testing as an example, the target test is not limited to this.

  First, the sample collection tool 2 will be described. As shown in FIG. 1, the sample collection tool 2 includes a shaft portion 4, a sample collection portion 3 that is integrally provided at one end in the longitudinal direction of the shaft portion 4, and an integral portion at the other end in the longitudinal direction. The cap part 5 is mainly composed. The cap unit 5 includes a gripping unit 5a that is held by the operator when operating the sample collection tool 2, and a sealing unit 5b that seals the first opening 61 of the sample adjusting container 6. The holding part 5a and the sealing part 5b are integrally formed by injection molding. The other end in the longitudinal direction of the shaft portion 4 of the sample collecting tool 2 is connected to and integrated with the sealing portion 5 b of the cap portion 5. In the present embodiment, the end portion of the shaft portion 4 is detachably embedded in the hole of the sealing portion 5b, but the end portion of the shaft portion 4 may be fixed to the sealing portion 5b, The shaft portion 4 and the sealing portion 5b may be integrally formed.

  The sealing part 5b of the cap part 5 of the present embodiment is fitted into the first opening 61 while contacting the inner wall 63 in the vicinity of the first opening 61 of the sample adjustment container 6, thereby The opening 61 is configured to be sealed. However, in the modified mode, the sealing portion 5b may have any configuration as long as the first adjustment portion 61 of the specimen adjustment container 6 is sealed so that the specimen adjustment container 6 can be sealed. For example, you may be comprised so that the 1st opening part 61 may be covered and sealed by fitting to this 1st opening part 61, contacting the outer wall 64 of the 1st opening part 61 vicinity. In addition, the grip portion 5a is formed in a substantially cylindrical shape in the present embodiment, but may be any shape that can be gripped when operating the sample collection tool 2, and may be a polygonal cylinder shape, an elliptical cylinder shape, a plate shape, The shape which gave various designs may be sufficient.

  As shown in FIGS. 1 and 2A and the like, the sealing portion 5b of the cap portion 5 is provided with a cap portion from the viewpoint of further improving the sealing performance between the sealing portion 5b of the cap portion 5 and the specimen adjustment container 6. Side engagement means 51 is preferably provided. In this embodiment, as the cap part side engaging means 51, the recessed part or recessed groove | channel which continues along the circumferential direction on the outer wall of the sealing part 5b, and it continues along the circumferential direction on the front end side along with this. Protrusions are provided. The cap portion side engaging means 51 is engaged with an opening side engaging means 61a of the sample adjusting container 6 described later, and the sealing portion 5b is securely fixed to the first opening 61 of the sample adjusting container 6. In addition, the first opening 61 is sealed. Specifically, the sealing is performed by closely contacting the distal end surface of the grip portion 5a on the sealing portion 5b side of the cap portion 5 with the distal end surface of the first opening 61 of the specimen adjustment container 6, and the cap of the sealing portion 5b. This is done by the close contact between the part-side engaging means 51 and the opening-side engaging means 61a of the specimen adjustment container 6. The cap side engaging means 51 may have any structure as long as it can be engaged with the opening side engaging means 61a. Specifically, for example, on the outer surface of the sealing portion 5b or the inner wall (not shown) of the outer peripheral cylinder provided on the outer side of the sealing portion 5b, one or a plurality of convex portions that are annularly continuous along the circumferential direction, Examples of the structure include a concave portion, a concave groove or rib, one or a plurality of convex portions that are spirally continuous in the circumferential direction, a concave portion, a concave groove or rib, or any combination thereof.

  The material of the cap portion 5 is not particularly limited, but a resin is preferable, and examples thereof include polystyrene, polypropylene, polyethylene, and ABS resin.

  Next, the configuration of the shaft portion 4 of the sample collecting tool 2 will be described with reference to FIG. The shaft part 4 is configured to have a length that allows the specimen to be collected by inserting the specimen collection tool 2 from the patient's nostril, mouth, etc., and wiping the back of the nose or throat with the specimen collection part 3 provided at the distal end. Has been. In the present embodiment, the shaft portion 4 includes a flexible portion 4a and a base portion 4b. The flexible part 4a is a small diameter part from a predetermined position to the specimen collecting part 3, and has flexibility to be deformed by applying stress. The base part 4b is a thick part from the boundary part with the flexible part 4a to the cap part 5, and has higher rigidity than the flexible part 4a. Thereby, when accommodating the sample collection part 3 and the shaft part 4 inside the sample adjustment container 6, by applying a force to the flexible part 4a of the shaft part 4, the flexible part 4a is bent or curved. The length of the shaft portion 4 in the deformed and housed state can be shortened. In addition, since the base 4b of the shaft portion 4 of the sample collection tool 2 is more rigid than the flexible portion 4a, the operability at the time of sample collection is not impaired.

  As shown in FIG. 1, the flexible portion 4a and the base portion 4b of the shaft portion 4 of the present embodiment are integrally formed, and the flexible portion 4a has a small diameter enough to be deformed by applying stress. The base portion 4b is formed to have a larger diameter than the flexible portion 4a, and is configured to have rigidity. Furthermore, the sample collection tool 2 according to the present embodiment has a portion close to the base 4b of the flexible portion 4a in order to improve the operability of the sample collection tool 2 when collecting the sample or storing the sample collection container 2 in the sample adjustment container 6. The diameter of the flexible part 4a is configured to increase stepwise toward the base part 4b so that the rigidity is higher than the rigidity of the distant part.

  At a predetermined position of the base portion 4b of the shaft portion 4, a notch 41 for easily cutting and dividing the base portion 4b in a direction perpendicular to the axial direction is provided. By bending the base portion 4b at the position where the notch 41 is provided, the base portion 4b is easily cut and divided in the axial direction. Therefore, the length of the shaft portion 4 accommodated in the specimen adjustment container 6 is further increased. Can be shortened.

  In the present embodiment, the notch 41 is a groove having a V-shaped cross section that is formed in the base portion 4b and is continuous in the circumferential direction when the shaft portion 4 is manufactured. However, in the modified embodiment, after forming a shaft portion without a notch, a notch whose depth is about 1/5 to 1/30 of the diameter of the base portion 4b is continuously used in the circumferential direction by using a sharp blade or the like. Thus, the notch 41 may be formed. By forming this, stress concentration occurs in the notch 41 due to the notch effect and the bending strength is reduced, so that the base portion 4b can be reliably cut at a predetermined position. In addition, according to the notch 41 by such a cut, since it is difficult to break even if the shaft portion 4 is greatly bent, the material is excellent in safety at the time of sample collection and is difficult to cut by simply bending (for example, polycarbonate resin). Even when the specimen collecting tool 2 is formed of a polyamide resin or an acrylic resin, it is possible to easily and reliably cut the base portion 4b at the position of the notch 41 by the cut.

  Further, the length of the flexible portion 4a and the base portion 4b of the specimen collecting tool 2 is such that the shaft portion 4 after the flexible portion 4a is bent or after the flexible portion 4a is bent and the base portion 4b is divided. And the sample collection unit 3 are preferably determined so that the total length of the original shaft unit 4 and the sample collection unit 3 is 70% or less, and preferably 60% or less. More preferably, it is more preferably set to be 50% or less. In the present embodiment, the length of the flexible portion 4a of the shaft portion 4 of the sample collection tool 2 and the length of the base portion 4b are set to be substantially the same, and the notch provided in the base portion 4b of the shaft portion 4 is set. 41 is formed so that the shaft portion 4 is divided at a position separated from the end of the shaft portion 4 on the cap portion 5 side by a length of about 1/3 of the length of the shaft portion 4.

  Although it does not specifically limit as a material which comprises the axial part 4, Resins, such as a polystyrene, polyethylene, a polypropylene, nylon, or polyester, are used suitably. Moreover, in this embodiment provided with the flexible part 4a in the axial part 4, the material which has the flexibility which deform | transforms by applying stress is selected.

  Next, the sample collection unit 3 of the sample collection tool 2 will be described. The sample collection unit 3 is integrally provided at the end of the shaft unit 4 on the flexible unit 4a side. The sample collection unit 3 may be any one that can attach a sample, and a cotton ball, a cotton swab equipped with a cotton ball, a sponge, a brush, or the like is appropriately selected. In particular, a cotton swab in which a synthetic fiber is flocked to form a cotton ball is preferably used because of its excellent sample collection function.

  The specimen collection tool 2 is preferably sterilized or sterilized in order to maintain a hygienic viewpoint and the accuracy of the test, and is preferably packaged one by one or more in a sterilized manner. Packaging is performed by being stored in a bag or a tube. Note that the gripping part 5a of the cap part 5 of the sample collecting tool 2 is not a part to which the specimen is attached, but is a part that is handled and operated by the operator without touching the patient. It may be exposed to the outside without any problem. In addition, when the sample collection tool 2 is packaged in a tube-type package, the opening of the tube-type package can be sealed with the sealing portion 5b of the cap portion 5.

  Next, the sample adjustment container 6 will be described with reference to FIGS. 1 and 2B. The sample adjustment container 6 is a cylindrical container provided with a first opening 61 for inserting the sample collection tool 2 on one end side, and contains an adjustment liquid 7 for dispersing or dissolving the collected sample. Has been. The first opening 61 is provided in advance with a first lid 62 for preventing the accommodated adjustment liquid 7 from flowing out and foreign matters from entering. The first lid 62 is configured to be detachable for inserting the sample collection tool 2 and can seal the first opening 61 of the sample adjustment container 6. Specifically, as the first lid 62, a film seal lid that covers the first opening 61 by attaching a resin film to the end face of the first opening 61 by an adhesive, heat sealing, ultrasonic welding or the like. In addition, a screw-type lid, a push-in stopper, etc. are used. By removing the first lid 62, the sealed state of the sample adjustment container 6 is once released, and the sample collection unit 3 and the shaft unit 4 of the sample collection tool 2 after sample collection can be inserted into the container interior 60. it can.

  After the first lid 62 is removed and the sealed state is released, the sample adjustment container 6 is stored in the container interior 60 after the sample collection part 3 and the shaft part 4 are accommodated in the cap part 5 of the sample collection tool 2. 1 opening 61 is sealed and sealed again. The opening shape of the first opening 61 may be a shape that is sealed by the cap portion 5 of the sample collecting tool 2, and in the present embodiment, the opening shape is a size that fits with the sealing portion 5b of the cap portion 5. Are formed in a substantially circular opening shape. That is, the first opening 61 is provided with opening side engaging means 61a from the viewpoint of further improving the sealing performance with the cap part 5 of the sample collecting tool 2. In the present embodiment, as shown in FIG. 1 and FIG. 2 (B), as the opening-side engaging means 61a, a convex portion that is continuous along the circumferential direction is provided on the inner wall 63 in the vicinity of the first opening 61. ing. The opening side engaging means 61a engages with the cap part side engaging means 51 of the cap part 5 of the sample collecting tool 2 as described above, and the sealing part 5b of the cap part 5 is engaged with the first opening part. The first opening 61 is sealed securely with the first opening 61. The opening side engaging means 61 a may have any structure as long as it can be engaged with the cap part side engaging means 51. Specifically, for example, in the inner wall 63 or the outer wall 64 of the first opening 61, one or a plurality of convex portions, concave portions, concave grooves or ribs that are annularly continuous along the circumferential direction, and a spiral shape in the circumferential direction. The structure which consists of 1 or several continuous convex part, a recessed part, a concave groove | channel or a rib, or these arbitrary combinations is mentioned.

  When a force is applied to the sealed sample adjustment container 6 from the outside, the sample adjustment container 6 is deformed, and the shape of the first opening 61 sealed with the cap 5 or the like is also deformed. As a result, the sealed state of the specimen adjustment container 6 may not be maintained. Therefore, it is preferable that the first opening 61 includes the reinforcing means 61b from the viewpoint of increasing the strength of the periphery thereof and reliably maintaining the sealed state of the specimen adjustment container 6. In the present embodiment, as the reinforcing means 61b, as shown in FIG. 2B, a plurality of convex ribs are annularly arranged on the outer wall 64 of the first opening 61. The reinforcing means 61b Any structure may be used as long as the strength around the first opening 61 is increased. For example, a structure in which the thickness of the container near the first opening 61 is increased may be employed.

  As shown in FIG. 4A, the sample collection tool 2 is inserted into the container interior 60 of the sample adjustment container 6 of the present embodiment with the sample collection unit 3 at the tip, and the sample collection unit 3 is immersed in the adjustment liquid 7. Is done. Thereafter, the sample collection part 3 and the shaft part 4 of the sample collection tool 2 are further pushed into the container interior 60, whereby the flexible part 4a is bent as shown in FIG. The length of is shortened. Further, as shown in FIG. 4C, the shaft portion 4 of the sample collecting tool 2 is cut and divided in the middle, and the divided shaft portion 4 on the distal end side and the sample collecting portion 3 are accommodated in the container interior 60. Is done. Therefore, the sample adjustment container 6 is formed to a size that can accommodate the sample collection unit 3 of the sample collection tool 2 and the shaft portion 4 on the distal end side that is bent and divided.

  Further, as shown in FIG. 1 and FIG. 3A, the adjustment liquid 7 containing the dispersed or dissolved sample is externally attached to the other end side of the sample adjustment container 6 opposite to the first opening 61. A second opening 65 is provided to be discharged to be used for inspection, and a second lid 66 for sealing the second opening 65 is provided in front of the second opening 65. . In the present embodiment, as shown in FIG. 1, the second lid 66 is formed of a thin film disposed at a predetermined distance from the second opening 65, and a filter device is formed on the thin film. The adjustment liquid 7 is discharged from the second opening 65 by forming the through hole 66 a at 8.

  Based on FIG.1 and FIG.5, the structure of the 2nd cover body 66 and the filter instrument 8 of this embodiment is demonstrated more concretely. As described above, the thin film-like second lid 66 is provided at a position away from the second opening 65 of the specimen adjustment container 6 by a predetermined distance. On the other hand, as shown in FIGS. 1 and 5, the filter device 8 includes the second opening 65 in the accommodation region 66 b between the second opening 65 and the second lid 66 of the sample adjustment container 6. A cylindrical portion 80 that is fitted in close contact with the inner wall 63, a through-hole forming point 81 disposed on one end side of the cylindrical portion 80, and an adjustment liquid flow path 82 that communicates with the inside of the cylindrical portion 80. And. An adjustment liquid outlet 83 is provided at one end of the adjustment liquid channel 82. As shown in FIG. 5, the filter device 8 is inserted into the second opening 65 of the sample adjustment container 6 by pushing the filter device 8 from the second opening 65 of the sample adjustment container 6 into the accommodation region 66b. A through hole 66 a is formed in the thin film constituting the second lid body 66 of the specimen adjustment container 6.

  In addition, in order to make it easier to take out the adjustment liquid 7 in the specimen adjustment container 6 to the outside more reliably, the through hole forming point 81 of the filter device 8 includes a thin portion 81a on the distal end side and a thickness on the proximal end side. It is also preferable that a step is provided between the thin portion 81a on the distal end side and the thick portion 81b on the proximal end side. In such a configuration, the step of the through hole forming point 81 abuts against the second lid 66 of the specimen adjusting container 6 and causes the thin film to be deformed. Thus, a gap is easily formed in the vicinity of the through-hole 66a formed in step (1), and the adjustment liquid 7 in the sample adjustment container 6 can be more reliably taken out through the gap. That is, the second lid body 66 is pierced by the thin portion 81a on the distal end side, and the pierced second lid body 66 is surely pushed upward by a step so that the passage of the adjustment liquid 7 near the through hole 66a. The adjustment liquid 7 in the sample adjustment container 6 can be reliably taken out through the passage.

  In addition, a plurality of slits (not shown) substantially parallel to the direction penetrating the second lid 66 of the specimen adjustment container 6 may be formed in the through hole forming point 81 of the filter device 8. preferable. Accordingly, when the through hole 66a is formed by breaking through the second lid 66 of the specimen adjustment container 6 with the through hole forming point 81, the adjustment liquid 7 in the specimen adjustment container 6 is removed from between the slits to the outside. Can be reliably removed.

  As shown in FIGS. 1 and 5, a filter 84 for filtering and removing the solid matter derived from the specimen contained in the adjustment liquid 7 is provided inside the cylindrical portion 80 of the filter device 8. Is provided. In some cases, the filter 84 may act to reduce the viscosity of the adjustment liquid 7 in which the specimen is dispersed or dissolved.

  The sample preparation container 6 is preferably formed of a transparent or translucent resin so that the state of the sample collection tool 2 accommodated therein or the amount of the adjustment liquid 7 can be visually confirmed. The specimen adjustment container 6 is preferably formed of a flexible material, and for example, low density polyethylene is suitably used. In that case, after the through-hole 66a is formed in the second lid 66, the body portion of the specimen adjustment container 6 is pressed to adjust from the outlet 83 at the tip of the adjustment liquid channel 82 of the filter device 8. The liquid 7 can be easily dropped.

  In addition, it is desirable that the wall surface of the body portion near the second opening 65 in the specimen adjustment container 6 is configured to be more flexible than the wall surface of the body portion near the first opening 61. Specifically, the body portion near the second opening 65 of the specimen adjustment container 6 is made flexible by making the thickness of the body portion near the second opening 65 thinner than the thickness of other portions. It is preferable that the wall surface is easily deformed by pressing with a finger and is restored to its original shape when the pressing force is removed. In this case, the adjustment liquid 7 can be quickly discharged by pressing the body portion near the second opening 65.

  Next, a method for using the test kit 1 according to the present embodiment will be described with reference to FIGS. 1 and 3 to 5.

  First, a sample is collected using the sample collection tool 2 shown in FIG. When collecting the sample, the sample collection unit 3 and the shaft unit 4 are operated by holding the grip portion 5 a of the cap unit 5. The specimen is collected by wiping the patient's nostril, pharynx, conjunctiva, urethra, uterus, vagina, stool, urine, sputum and the like with the specimen collection unit 3. The collected specimen adheres to the specimen collection section 3 and is held.

  On the other hand, the first lid 62 is removed from the first opening 61 of the sample adjustment container 6, and the sample collection tool 2 after sample collection is held in a state where the holding unit 5 a of the cap unit 5 is held. As shown to (A), it inserts from the 1st opening part 61 of the sample adjustment container 6 with the sample collection part 3 as a front-end | tip. As a result, the sample collection unit 3 is immersed in the adjustment liquid 7 accommodated in the sample adjustment container 6, and the sample attached to the sample collection unit 3 is dispersed or dissolved in the adjustment liquid 7.

  Next, as shown in FIG. 4B, the sample collection unit 3 and the shaft unit 4 are pushed into the container interior 60 while holding the grip portion 5 a of the cap unit 5 of the sample collection tool 2. The flexible part 4a of the sample collection part 3 or the shaft part 4 is pressed against the wall surface or bottom of the container interior 60 to apply a force, and the flexible part 4a is bent and deformed into a loop shape. As a result, the combined length of the shaft portion 4 and the sample collection portion 3 of the sample collection device 2 accommodated in the container inside 60 of the sample adjustment container 6 can be substantially shortened.

  Next, as shown in FIG. 4C, the position where the notch 41 of the base portion 4b of the shaft portion 4 of the sample collecting tool 2 is pressed against the edge of the first opening 61 and bent. At this position, the base 4b is cut and divided. Accordingly, the substantial lengths of the shaft portion 4 and the sample collection portion 3 of the sample collection tool 2 accommodated in the container inside 60 of the sample adjustment container 6 can be further shortened. The substantial lengths of the shaft portion 4 and the sample collection portion 3 of the sample collection tool 2 after the flexible portion 4a is bent and the base portion 4b is divided at the position where the notch 41 is formed are as follows. It is possible to make it 50% or less of the original total length. In addition, the deformation | transformation aspect of the flexible part 4a does not necessarily need to be a loop shape like illustration, For example, a curved shape with a large curvature, S shape etc. may be sufficient.

  As shown in FIG. 3 (A), the divided portion of the base portion 4b of the shaft portion 4 is placed inside the container of the sample adjustment container 6 with the gripping portion 5a of the cap portion 5 of the sample collecting tool 2 in this manner. The first opening 61 of the specimen adjustment container 6 is sealed and sealed with the sealing portion 5b of the cap portion 5 as it is. In this way, from the time of sample collection to the containment of the used sample collection device 2 can be operated and processed while holding the grip portion 5a of the cap portion 5 of the sample collection device 2 in the dominant hand, so that the efficiency is improved. Well, safe and easy inspection.

  Further, when the first opening 61 of the specimen adjustment container 6 is sealed with the sealing part 5b of the cap part 5, as shown in FIG. 3B, the sealing part 5b of the cap part is provided. The cap-side engaging means 51 and the opening-side engaging means 61a provided in the first opening 61 of the sample adjusting container 6 are engaged, and the sample adjusting container 6 is reliably sealed. Therefore, even if the entire specimen adjustment container 6 is swung or shaken, the adjustment liquid 7 does not leak, and the specimen and the adjustment liquid 7 can be sufficiently mixed and processed.

  Next, in a state where the sealing lid 9 is attached to the filter device 8 shown in FIG. 1, the filter device 8 is pushed from the second opening 65 of the specimen adjustment container 6 into the accommodation region 66 b to be fitted therein. As shown in FIG. 5, the through-hole forming point 81 of the filter device 8 pushes up and tears the thin film of the second lid 66 of the specimen adjustment container 6, thereby forming a through-hole 66 a through which the adjustment liquid 7 passes. . At this time, since the sealing lid 9 is attached to the filter device 8, the adjustment liquid 7 does not leak to the outside even if the through hole 66a is formed.

  Thereafter, as shown in FIG. 5, the sealing lid 9 is removed, and at least a part of the adjustment liquid 7 passes through the adjustment liquid flow path 82 from the through hole 66 a formed in the second cover body 66 of the specimen adjustment container 6. The sample is taken out from the outlet 83 and used for inspection.

  Then, after the adjustment liquid 7 is taken out, the adjustment liquid outlet 83 is sealed with the sealing lid 9. Thereby, the test kit 1 can be discarded in a state where the adjustment liquid 7 does not leak to the outside. In this way, it is possible to efficiently handle and process specimens when examining specimens that may contain viruses, highly infectious bacteria, and the like.

  Next, a second embodiment of the present invention will be described.

  As shown in FIG. 6, the test kit 10 according to the second embodiment of the present invention is different from the test kit 1 according to the first embodiment in the configuration of the sample collection tool 20. The same sample adjustment container 6 as that of the embodiment, a filter device 8, and a sealing lid 9 are provided.

  A configuration of the shaft portion 40 of the sample collecting tool 20 of the present embodiment will be described. The shaft portion 40 is configured to have such a length that a sample can be collected by inserting the sample collection tool 20 from the patient's mouth or the like and wiping the back of the throat with the sample collection unit 30 provided at the tip of the sample. . In the present embodiment, the shaft portion 40 is formed to have substantially the same diameter as a whole, and has a thickness that does not impair the operability during sample collection. Although it does not specifically limit as a material which comprises the axial part 40, Synthetic resins, such as a polystyrene, polyethylene, a polypropylene, nylon, or polyester, are used suitably.

  At a predetermined position of the shaft portion 40, at least one notch 410 for easily cutting and dividing the shaft portion 40 in the direction perpendicular to the axial direction is provided. By bending the shaft portion 40 at the position where the notch 410 is provided, the shaft portion 40 is easily cut and the shaft portion 40 is divided in the axial direction. Can be accommodated with a shorter length. In the present embodiment, two notches 410 are provided, and the shaft portion 40 is divided into three parts and can be accommodated in the sample adjusting container 6.

  The position where the notch 410 is provided in the shaft part 40 and the number of the notches 410 provided in the shaft part 40 are the total length of the divided shaft part 40 and the sample collecting part 30 and the original shaft part 40. It is preferably determined to be 70% or less of the total length of the sample collection unit 30, more preferably 60% or less, and even more preferably 50% or less. In the present embodiment, two cutouts 410 are provided so that the combined length of the shaft portion 40 of the sample collecting tool 20 and the sample collecting tool 30 is divided into approximately three equal parts.

  In this embodiment, the notch 410 is formed by a groove having a V-shaped cross section that is continuous in the circumferential direction and is formed on the shaft portion 40 when the shaft portion 40 is manufactured. However, in the modified embodiment, after forming the notched shaft portion 40, a notch with a depth of about 1/5 to 1/30 of the diameter of the shaft portion 40 is formed in the circumferential direction using a sharp blade or the like. The notches 410 may be formed by continuously forming the notches 410. By forming this, stress concentration occurs in the notch 410 due to the notch effect and the bending strength is reduced, so that the shaft portion can be reliably cut at a predetermined position.

  The other description regarding the structure of the sample collection tool 20 is the same as that of the first embodiment described above, and the operational effects thereof are also the same. In addition, the description of each configuration of the specimen adjustment container 6 constituting the test kit 10, the filter device 8, and the sealing lid 9 is the same as in the case of the first embodiment described above, and the operational effects thereof are also the same. is there.

  Next, based on FIGS. 6-8, the usage method of the test kit 10 which concerns on this embodiment, especially the usage method of the sample collection tool 20 are demonstrated.

  First, a sample is collected using the sample collection tool 20 shown in FIG. When collecting the specimen, the specimen collection section 30 and the shaft section 40 are operated by holding the grip section 50a of the cap section 50. The specimen is collected by wiping the patient's nostril, pharynx, conjunctiva, urethra, uterus, vagina, stool, urine, sputum and the like with the specimen collection unit 30. The collected specimen adheres to the specimen collection unit 30 and is held.

  On the other hand, the first lid 62 is removed from the first opening 61 of the sample adjustment container 6, and the sample collection tool 20 after sample collection is held in a state where the holding unit 50 a of the cap unit 50 is held. As shown to (A), it inserts from the 1st opening part 61 of the sample adjustment container 6 with the sample collection part 30 as a front-end | tip. As a result, the sample collection unit 30 is immersed in the adjustment liquid 7 accommodated in the sample adjustment container 6, and the sample attached to the sample collection unit 30 is dispersed or dissolved in the adjustment liquid 7.

  Next, as shown in FIG. 7 (B), the sample 50 of the notches 410 provided in the shaft portion 40 of the sample collection tool 20 with the grip 50a of the cap 50 of the sample collection tool 20 is provided. The position of the notch 410 on the sampling part 30 side is pressed against the edge of the first opening 61 and bent, whereby the shaft part 40 is cut and divided at this position. Thereby, the substantial length of the axial part 40 of the sample collection tool 20 accommodated in the container inside 60 of the sample adjustment container 6 and the sample collection part 30 can be shortened.

  Subsequently, as shown in FIG. 7C, the position where the notch 410 on the cap portion 50 side of the shaft portion 40 of the sample collecting tool 20 is pressed against the edge of the first opening 61 and bent. Thus, the shaft portion 40 is cut and divided at this position. As a result, the substantial lengths of the shaft portion 40 and the sample collecting portion 30 of the sample collecting tool 20 accommodated in the container inside 60 of the sample adjusting container 6 can be further shortened. The substantial length of the shaft portion 40 and the sample collection portion 30 of the sample collection tool 20 after the shaft portion 40 is divided at the position where the two notches 410 are formed is the original total length of the sample collection device 20. It is possible to make it 50% or less.

  Next, as shown in FIG. 8, with the holding part 50 a of the cap part 50 of the sample collection tool 20, the divided part of the shaft part 40 is accommodated in the container inside 60 of the sample adjustment container 6, The first opening 61 of the specimen adjustment container 6 is sealed and sealed with the sealing part 50 b of the cap part 50. In this way, from the time of sample collection to the containment of the used sample collection tool 20 can be operated and processed while holding the grip part 50a of the cap part 50 of the sample collection tool 2 in the dominant hand, so that the efficiency is improved. Well, safe and easy inspection.

  The other description regarding the usage method of the sample collection tool 20 is the same as that of the first embodiment described above, and the functions and effects thereof are also the same. In addition, the description regarding each method of using the specimen adjustment container 6 constituting the test kit 10, the filter device 8, and the sealing lid 9 is the same as in the case of the first embodiment described above, and its functions and operations are the same. The effect is the same.

  The present invention is not limited to the above-described embodiment, but includes variously modified forms within the technical scope without departing from the gist of the invention described in the claims.

DESCRIPTION OF SYMBOLS 1,10 Test kit 2,20 Specimen collection tool 3,30 Specimen collection part 4,40 Shaft part 4a Flexible part 4b Base part 41,410 Notch 5,50 Cap part 5a, 50a Grasping part 5b, 50b Sealing part 51, 510 Cap portion side engaging means 6 Specimen adjustment container 60 Container interior 61 First opening 61a Opening side engaging means 61b Reinforcing means 62 First lid 63 Inner wall 64 Outer wall 65 Second opening 66 Second 2 Lid 66a Through-hole 66b Accommodating area 7 Adjustment liquid 8 Filter device 80 Cylindrical part 81 Through-hole forming point 81a Thin part 81b Thick part 82 Adjustment liquid channel 83 Adjustment liquid outlet 84 Filter 9 Sealing lid

Claims (7)

A sample collection tool for collecting a sample and a first opening for inserting the sample collection tool on one end side, and an adjustment liquid for dispersing or dissolving the collected sample is contained inside A test kit including a prepared sample preparation container,
The sample collecting tool includes a shaft portion, a sample collecting portion integrally provided at one end in the longitudinal direction of the shaft portion, and a cap portion integrally provided at the other end in the longitudinal direction of the shaft portion. Prepared,
The specimen adjustment container is configured to accommodate the specimen collection part and the shaft part inside,
The cap part is configured to seal the first opening of the sample adjustment container so as to seal the sample adjustment container containing at least the sample collection part and the shaft part. Test kit. The cap portion includes at least one cap portion side engaging means disposed along the circumferential direction on the inner wall or the outer wall thereof,
The specimen adjustment container includes an opening side engaging means that engages with the cap part side engaging means disposed along a circumferential direction on an outer wall or an inner wall in the vicinity of the first opening. The test kit according to claim 1. The sample adjustment container is configured such that the axial length thereof is shorter than the total length of the shaft portion of the sample collection tool and the length of the sample collection portion,
The test kit according to claim 1 or 2, wherein the shaft portion of the sample collecting tool has at least one notch for dividing the shaft portion in the axial direction. .   The shaft portion of the sample collection tool has a flexible portion that deforms when stress is applied to the sample collection portion side, and a base portion that is more rigid than the flexible portion from the flexible portion to the cap. The test kit according to any one of claims 1 to 3, wherein the test kit is provided on a part side.   The specimen adjustment container includes a first lid that seals the first opening to seal the specimen adjustment container and is removable to insert the specimen collection tool. The test kit according to any one of claims 1 to 4.   A second opening for discharging the adjustment liquid containing the sample dispersed or dissolved in the adjustment liquid to the outside is provided on the other end side of the sample adjustment container. The inspection according to any one of claims 1 to 5, further comprising a second lid for sealing provided in the vicinity of the second opening to seal the adjustment container. For kit.   In order to filter the adjustment liquid containing the specimen dispersed or dissolved in the adjustment liquid, the filter apparatus further includes a filter device fitted in the second opening, and the second lid body includes the filter device. The test kit according to claim 6, wherein the test kit is configured to be opened by fitting into the second opening.

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