JP6424666B2 - Test kit and preparation container provided therewith - Google Patents

Description

  The present invention prepares a suspension by dissolving a sample collected using a collection tool in a buffer for sample dissolution stored in a preparation container, and testing the suspension after preparation from the preparation container The present invention relates to a test kit configured to test a sample by being introduced into a medical instrument and a preparation container included in the test kit, and in particular, a test kit suitably used in the field of clinical test and the same Preparation container.

  In the field of clinical examination, it is mainly examined whether the collected sample contains occult blood, an enzyme, a virus, etc., and if so, how much the amount is. One of the clinical examinations is a fecal occult blood test and an infectious disease test using stool as a sample. The fecal occult blood test is widely used, for example, in screening for colon cancer and rectum cancer, and the infection test is widely used, for example, in testing for the presence or absence of infection of a virus represented by norovirus.

  In these fecal occult blood tests and infectious disease tests, a suspension is prepared by dissolving stool in a stool lysis buffer, and the prepared suspension is attached to a test strip to determine whether it is positive or negative. Inspection is conducted. As a test kit that can be suitably used for the fecal occult blood test and infectious disease test, for example, there is a kit disclosed in JP-A-10-185912 (Patent Document 1).

  The test kit disclosed in Patent Document 1 includes a stool collection rod as a collection tool, a sample container as a preparation container, and a determination container as a test tool. A suspension is prepared by dissolving stool collected using a stool in a buffer for dissolving feces stored in a sample container, and the suspension after preparation is a sample. It is comprised so that a test | inspection of stool may be performed by being introduce | transduced into a determination container from a container.

  Here, in the judgment container, a communication needle as a puncture needle in which a flow path is provided inside and a hole is provided in a sharp end is formed, and chromatography as a test strip is provided on the downstream side of the flow path A filter paper is accommodated, and a thin film which can be pierced by the above-mentioned communication needle is formed on the bottom of the sample container. As a result, when the sample container is attached to the determination container, the thin film is opened by the communication needle, whereby the suspension stored in the sample container flows down to the chromatography filter paper through the communication needle. It will be.

  Therefore, by using the test kit disclosed in Patent Document 1 above, the work of the test operator is facilitated, and the introduction of the suspension from the sample container to the judgment container is performed in a substantially sealed state. There is no risk of the virus or bacteria infecting humans, and the test workers are not bothered by odors.

Japanese Patent Application Laid-Open No. 10-185912

  In general, the suspension after preparation often contains a sample (that is, a residue as a solid) which has not been dissolved in the sample dissolving buffer. The residue interferes with accurate inspection if it adheres to the test strip.

  As one method for solving the problem, in the test kit as disclosed in the above-mentioned Patent Document 1, in order to remove the residue in the judgment container of the portion positioned on the upstream side of the chromatography filter paper as the test strip. It is conceivable to install a filter of

  However, even when the configuration is adopted, it is inevitable that the residue flows into the determination container, and therefore, if the inflow amount is large, the filter may be clogged. If such clogging occurs, there may be a delay in the time it takes for a sufficient amount of suspension to adhere to the test strip (ie inspection time), or in the worst case the suspension will Problems can arise in that the film does not adhere to the graphic filter paper and the inspection itself can not be performed.

  Therefore, the present invention has been made to solve the above-mentioned problems, and can prevent the transfer of a sample that has not been dissolved in the sample dissolving buffer to the testing instrument. It is an object of the present invention to provide a test kit that can prevent the occurrence of a delay in test time and an inability to perform the test itself, and a preparation container provided therein.

The test kit according to the present invention comprises a collection tool, a preparation container and a test tool. The above-mentioned collection device is for collecting a sample. The preparation container is prepared by storing the sample dissolution buffer and attaching the collection tool so that the sample collected by the collection tool is dissolved in the sample dissolution buffer. It is for storing a suspension. The inspection instrument is configured to be attachable to the preparation container, and the specimen is inspected using the suspension introduced from the preparation container in a mounted state in which the preparation container is attached. It is. In the preparation container, a storage space for storing the sample dissolving buffer and the suspension is provided inside. The inspection instrument is provided with a puncture needle having a flow path inside for introducing the suspension from the preparation container in the mounted state, and the puncture needle has the storage in the mounted state. A hole for communicating the space with the flow path is provided. The bottom portion of the preparation container closes a protruding cylindrical portion projecting toward the storage space, and closes the end portion of the protruding cylindrical portion on the storage space side, and in the mounted state, the puncture needle A thin film portion to be opened is provided. The storage space includes a trap space for capturing a sample that has not been dissolved in the sample dissolving buffer, and the trap space is a protrusion of the protruding cylindrical portion so as to surround the protruding cylindrical portion. It is comprised by the annular space provided adjacent to the said projecting cylindrical part in the direction which cross | intersects a direction. In the test kit based on the said invention, the partition part which divides the said trap space in the circumferential direction is provided in the said bottom part.

  In the test kit according to the present invention, the test device may further include a filter disposed downstream of the flow path, and a test strip disposed downstream of the filter. .

The preparation container according to the present invention is provided with a storage space for storing a suspension prepared by dissolving a sample in a sample dissolving buffer, and the storage space side And a thin film portion for closing an end of the protruding cylindrical portion on the side of the storage space. The storage space includes a trap space for capturing a sample that has not been dissolved in the sample dissolving buffer, and the trap space is a protrusion of the protruding cylindrical portion so as to surround the protruding cylindrical portion. It is comprised by the annular space provided adjacent to the said projecting cylindrical part in the direction which cross | intersects a direction. In the container for preparation based on the above-mentioned present invention, the partition part which partitions off the above-mentioned trap space in the circumferential direction is provided in the above-mentioned bottom.

  According to the present invention, it is possible to suppress migration of a sample that has not been completely dissolved in the sample lysis buffer to the testing instrument, thereby making it impossible to cause a delay in the examination time or the examination itself. It can be set as the test kit which can prevent becoming dead, and the preparation container comprised to this.

It is a perspective view which shows the mounting state of the test kit which concerns on embodiment of this invention. It is a perspective view which shows the decomposition | disassembly state of the test kit which concerns on embodiment of this invention. It is a sectional view of a preparation container concerning an embodiment of the invention. It is an expansion perspective view of field IV shown in FIG. It is sectional drawing of the test | inspection instrument of the test kit which concerns on embodiment of this invention. FIG. 6 is a rear view of the inspection instrument shown in FIG. 5; It is sectional drawing in the mounting state of the test kit which concerns on embodiment of this invention. It is an enlarged view of the area | region VIII shown in FIG. It is a principal part expansion perspective view of a container for preparation concerning a modification based on an embodiment of the present invention. It is sectional drawing of the test | inspection instrument of the test kit which concerns on the other modification based on embodiment of this invention.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiment shown below exemplifies the case where the present invention is applied to a test kit having as a sample stool which can be suitably used for clinical tests such as a fecal occult blood test and an infectious disease test, and a preparation container provided therein. It is a thing. In the embodiments described below, the same or common parts are denoted by the same reference numerals in the drawings, and the description thereof will not be repeated.

  FIG. 1 is a perspective view showing a mounted state of a test kit according to an embodiment of the present invention, and FIG. 2 is a perspective view showing a disassembled state of the test kit. FIG. 3 is a cross-sectional view of the preparation container included in the test kit according to the present embodiment, and FIG. 4 is an enlarged perspective view of a region IV shown in FIG. FIG. 5 is a cross-sectional view of the test device of the test kit according to the present embodiment, and FIG. 6 is a rear view of the test device shown in FIG. First, the configuration of the test kit according to the present embodiment will be described with reference to FIGS. 1 to 6.

  As shown in FIGS. 1 and 2, the test kit 1 includes a collection device 100, a preparation container 200, and a test device 300. As shown in FIG. 2, the collection device 100 is configured to be detachably attachable to the preparation container 200, and the preparation container 200 can be attached to the inspection device 300. It is configured. Thereby, as shown in FIG. 1, in the attached state of the inspection kit 1, the preparation container 200 in the attached state of the collecting device 100 is attached to the inspection device 300 in a standing posture. Become.

  As shown in FIG. 1 and FIG. 2, the collection tool 100 has an elongated rod-like shape as a whole, and the collection part 110, the plug part 120, the collar part 130, the shaft part 140, and collection And 150. FIG.

  The gripping portion 110 is a portion that the subject and the inspection worker grip with the fingers when handling the collection device 100. The plug portion 120 is a portion serving as a lid for sealing the space inside the preparation container 200 from the external space in a state where the collection tool 100 is attached to the preparation container 200, and is directed downward from the grip portion 110 It extends. The collar 130 is provided so as to protrude radially outward at the boundary between the grip 110 and the stopper 120, and in a state in which the collecting device 100 is attached to the preparation container 200, the forging is provided. This is a portion to be held against the container 200.

  The shaft portion 140 is a portion for fixing the collecting portion 150 to the plug portion 120, and extends downward from the plug portion 120. The shaft portion 140 has an outer shape thinner than the plug portion 120. The collection unit 150 is provided at the lower end of the shaft unit 140, and is a part that holds the sample by being pressed against the sample when collecting the sample. The collection unit 150 may have any shape as long as it can hold the sample, and for example, asperities and grooves may be provided on the surface.

  The collection device 100 preferably has an appropriate hardness and elasticity, and is an injection-molded article made of a resin material such as polyethylene resin, polypropylene resin, polyester resin, acrylonitrile butadiene styrene copolymer synthetic resin, etc. It consists of In addition, it is not necessary to necessarily be comprised with the injection molding goods which consist of a resin material which was mentioned above as the collection instrument 100, and it may be substituted by the cotton swab and the member similar to this.

  As shown in FIGS. 1 to 4, the preparation container 200 has a bottomed cylindrical shape, and includes a cylindrical portion 210 and a bottom portion 220. An upper end side opening portion 211 is provided on the upper end side in the axial direction of the cylindrical portion 210, and the bottom portion 220 is located on the lower end side of the cylindrical portion 210. Thus, the preparation container 200 has the storage space 201 capable of storing the sample dissolving buffer therein.

  The preparation container 200 has a size such that the collection unit 150 provided at the lower end of the collection tool 100 can be accommodated in the storage space 201 described above. As a result, in a state where the collection device 100 is attached to the preparation container 200, the collection unit 150 is immersed in the sample dissolving buffer stored in the preparation container 200.

  An annular first engaging projection 212 is provided on the inner peripheral surface of the cylindrical portion 210 in a portion located near the upper opening 211 of the preparation container 200 so as to protrude radially inward. There is. The inner diameter of the first locking projection 212 is formed to be slightly smaller than the outer diameter of the plug portion 120 of the collecting instrument 100 described above. Thereby, in a state in which the collection tool 100 is attached to the preparation container 200, the plug portion 120 is locked in a state of being in close contact with the first locking projection 212, and the sealability in the relevant portion is secured. It will be done.

  On the other hand, at a predetermined position in the axial direction of the outer peripheral surface of the cylindrical portion 210 of the preparation container 200, an annular second locking projection 213 is provided so as to protrude radially outward. The second locking projection 213 is a portion for fixing the preparation container 200 to the inspection tool 300 in a state where the preparation container 200 is attached to the inspection tool 300.

  As shown in FIGS. 3 and 4, the bottom 220 of the preparation container 200 protrudes toward the storage space 201 (that is, the side on which the upper end opening 211 is located) along the axial direction of the cylindrical portion 210. And a thin film portion 231 for closing an end of the protruding cylindrical portion 230 on the storage space 201 side. Thus, the storage space 201 includes the inner peripheral surface of the cylindrical portion 210, the outer peripheral surface of the protruding cylindrical portion 230, the upper surface of the thin film portion 231, and the bottom portion 220 of the portion where the protruding cylindrical portion 230 is not provided. It will be defined by the top surface.

  By adopting the above configuration, an annular space is located in a direction intersecting the protruding direction of the projecting cylindrical portion 230 (that is, the axial direction of the cylindrical portion 210) so as to surround the projecting cylindrical portion 230. become. The annular shaped space is used for the sample that could not be dissolved in the sample dissolving buffer (ie, the solid residue 410 (see FIG. 8) contained in the suspension 400 (see FIGS. 7 and 8)). The trap space 202 corresponds to the trap space 202 for capturing, and the storage space 201 described above includes the trap space 202.

  Here, in the thin film portion 231 described above, when the preparation container 200 is attached to the inspection instrument 300, a puncture needle 334 (see FIG. 5 etc.) described later provided in the inspection instrument 300 is pierced. It is a part which is opened by. The thin film portion 231 is a portion formed to be sufficiently thin compared to the other portions of the preparation container 200, and the pointed end portion 334b of the puncture needle 334 (see FIG. 5 etc.) when piercing the puncture needle 334. ) Is preferably deformed to a considerable extent along the axial direction of the cylindrical portion 210 and plastically deformed, and it is preferable that the thickness be such that breakage occurs thereafter.

  On the other hand, a puncture needle insertion passage 203 which is a cylindrical space is formed inside the projecting cylindrical portion 230. The puncture needle insertion path 203 is a portion through which the puncture needle 334 is inserted when the preparation container 200 is attached to the inspection instrument 300. Further, the lower end side opening 221 is located at the lower end of the puncture needle insertion path 203, and the lower end side opening 221 is a part for guiding the above-mentioned puncture needle 334 to the puncture needle insertion path 203. .

  Here, as shown in FIG. 4, the lower end side opening 221 described above is provided with an annular protrusion 222 so as to protrude radially inward. The inner diameter of the annular protrusion 222 is slightly smaller than the outer diameter of a main body portion 334a (see FIG. 5 and the like) which is a portion excluding a tapered tip portion 334b of a puncture needle 334 described later. As a result, in a state where the preparation container 200 is attached to the inspection instrument 300, the main body portion 334a is in close contact with the annular projection 222, and the sealability in the portion is secured.

  The preparation container 200 preferably has appropriate hardness and flexibility, and is made of, for example, a resin material such as polyethylene resin, polypropylene resin, polyvinyl chloride resin, polybutadiene resin, polystyrene resin, polyester resin, etc. It comprises an injection molded article. Here, the preparation container 200 is preferably made of a transparent or semi-transparent member, and in such a configuration, the specimen 100 is attached to the preparation container 200. It becomes possible to visually recognize from the outside the degree of dissolution of the sample in the lysis buffer. Therefore, when the dissolution of the sample is insufficient, the preparation of the suspension 400 can be ensured by shaking the preparation container 200 or the like.

  As shown in FIG. 1, FIG. 2, FIG. 5 and FIG. 6, the inspection instrument 300 has a base portion 301 and an upright wall portion 302 configured to have a substantially L shape in side view; Mainly includes a receiving portion 303 provided at a position adjacent to the standing wall portion 302 and a needle portion 304 provided inside the receiving portion 303.

  More specifically, as shown in FIG. 5, the outer shape of the inspection instrument 300 is defined by the cover member 320 and the base member 330 as the casing 310, and the above-mentioned base portion 301 and standing wall portion 302 are The cover member 320 and the base member 330 are configured in combination, and the receiving portion 303 and the needle portion 304 described above are configured by a part of the base member 330.

  By combining the cover member 320 and the base member 330, a housing space 305 having a substantially L-shaped side view is formed inside the casing 310. In the housing space 305, a strip-like test strip 350 bent into a substantially L shape according to the shape of the housing space 305 is housed, and the test strip 350 is sandwiched by the cover member 320 and the base member 330. And is fixed to the casing 310.

  The test strip 350 represents the test result by the attachment of the suspension 400, and makes it possible to determine whether the test strip 350 is colored or not, for example, whether it is positive or negative. For example, chromatography filter paper can be used as the test strip 350. Specifically, when the test kit 1 according to the present embodiment is used for a fecal occult blood test, a reagent that changes color in response to fecal occult blood will be applied in advance to the chromatography filter paper, and an infectious disease When used for a test, an antibody corresponding to the virus is fixed in advance to the chromatography filter so as to be discolored in response to the virus to be tested.

  As shown in FIG. 5 and FIG. 6, a window 321 for exposing the test strip 350 is provided at a predetermined position of the cover member 320 of the portion constituting the upright wall portion 302. The window 321 makes it possible to visually recognize from the outside whether or not the test strip 350 described above is discolored.

  As shown in FIG. 5, the receiving portion 303 is constituted by a substantially cylindrical cylindrical wall portion 331 provided on the base member 330, and inside the receiving portion 303, the receiving portion 303 is closer to the lower end of the preparation container 200. A receiving space 306 is provided which allows the part to be received. The receiving space 306 is located on the pedestal portion 301, and the housing space 305 provided in the inside of the pedestal portion 301 of the portion located below the receiving space 306 has one end of the test strip 350 described above. It is arranged.

  The base member 330 in a portion defining the lower end of the receiving space 306 is provided with a needle portion 304 so as to protrude toward the receiving space 306 (ie, the upper side). The needle portion 304 has an enlarged diameter portion 333 at a position on the root side, and has a puncture needle 334 at a position on the tip side.

  The puncture needle 334 is located continuously to the enlarged diameter portion 333 and is formed so as to be continuous with the main body portion 334a formed in a substantially cylindrical shape and the main body portion 334a, and has a generally conical shape so as to have a tapered shape. And a pointed portion 334b. Further, a flow passage 307 formed of a hollow space extending along the axial direction of the puncture needle 334 is formed in the inside of the puncture needle 334, and the pointed end 334 b of the puncture needle 334 A plurality of holes 335 are provided in communication with the receiving space 306 described above.

  The puncture needle 334 is for opening by piercing the thin film portion 231 provided on the bottom 220 of the preparation container 200 when the preparation container 200 is attached to the inspection instrument 300. In a state where the preparation container 200 is attached to the inspection instrument 300, the suspension 400 stored in the preparation container 200 is inspected by communicating the storage space 201 of the preparation container 200 with the flow path 307 described above. It is for introduce | transducing the inside of the fixture 300. FIG. Therefore, the hole 335 described above brings the storage space 201 of the preparation container 200 into communication with the flow path 307 described above in a state where the preparation container 200 is mounted on the inspection instrument 300.

  The enlarged diameter portion 333 is formed in a substantially cylindrical shape, and the outer shape thereof is larger than that of the main body portion 334 a of the puncture needle 334 described above. A filter 340 is housed inside the enlarged diameter portion 333, and the filter 340 is located on one end of the test strip 350 described above. The filter 340 is for filtering and capturing the residue 410 contained in the suspension 400 introduced into the inspection instrument 300, and may be made of, for example, polyethylene resin, polypropylene resin, fluorine resin, nylon resin, etc. A porous body made of a resin material or a porous body made of various inorganic materials can be used, and a polyethylene sintered porous body can be used particularly preferably.

  The upper end of the cylindrical wall portion 331 defining the receiving space 306 is provided with a receiving opening 332 which enables the container 200 to be received, and the cylindrical wall portion of the portion located in the vicinity of the receiving opening 332 A locking claw 336 is provided on the inner peripheral surface of the 331. The locking claw 336 is a portion that locks the second locking protrusion 213 provided on the outer peripheral surface of the cylindrical portion 210 of the preparation container 200 in a state where the preparation container 200 is mounted on the inspection tool 300. When the locking claw 336 locks the second locking projection 213, the preparation container 200 is stably fixed to the inspection instrument 300.

  The casing 310 defining the outer shape of the inspection tool 300 preferably has appropriate hardness and elasticity, and is, for example, a resin material such as polyethylene resin, polypropylene resin, polyester resin, acrylonitrile butadiene styrene copolymer synthetic resin, etc. It consists of an injection-molded article which used as a raw material.

  The test kit 1 according to the present embodiment described above is used based on the following procedure.

  First, in the test kit 1, the collection device 100 and the preparation container 200 are delivered to the subject in a state where the collection device 100 is attached to the preparation container 200. In this state, a predetermined amount of the sample dissolving buffer is stored in advance in the storage space 201 provided inside the preparation container 200. In this state, the plug portion 120 provided in the collection tool 100 is in close contact with and engaged with the first locking projection 212 provided in the preparation container 200, whereby the sample dissolving buffer solution is used. Is prevented from leaking out.

  Next, the subject removes the collection tool 100 from the preparation container 200, and uses the collection tool 100 to collect a sample. As a result, the sample is held in the collection unit 150 of the collection tool 100.

  Next, the subject attaches the collection instrument 100 to the preparation container 200. As a result, the collection unit 150 of the collection device 100 in the state of holding the sample is immersed in the sample dissolving buffer stored in the preparation container 200, and the sample is the sample dissolving buffer. And the suspension 400 is prepared. Further, at that time, the plug portion 120 provided in the collection device 100 comes into close contact again with the first locking projection 212 provided in the preparation container 200 and is thereby locked. Is prevented from leaking out.

  Thereafter, the preparation container 200 and the collection tool 100 in which the suspension 400 is stored are delivered to the inspection worker. The inspection worker ensures preparation of the suspension 400 by shaking and moving it as needed, and then inserts a portion near the lower end of the preparation container 200 into the receiving portion 303 of the inspection tool 300.

  At that time, the second locking provided on the outer peripheral surface of the preparation container 200 by reliably inserting the preparation container 200 until the preparation container 200 can not be further inserted into the receiving portion 303. The projection 213 rides over the locking claw 336 provided on the inner peripheral surface of the cylindrical wall portion 331 of the inspection instrument 300. As a result, the second locking projection 213 is locked by the locking claw 336, and the preparation container 200 is mounted on the inspection instrument 300. Also in this state, the collecting instrument 100 is kept attached to the preparation container 200.

  When the preparation container 200 is attached to the inspection instrument 300, the thin film portion 231 provided on the bottom 220 of the preparation container 200 is pierced by the puncture needle 334 provided on the inspection instrument 300. It will be. As a result, an opening by piercing is formed in the thin film portion 231, and the pointed end portion 334b of the puncture needle 334 and the main portion 334a of the portion located in the vicinity reach the inside of the storage space 201, which will be described later. It is possible to introduce the suspension 400 from the preparation container 200 into the examination instrument 300.

  When the portion near the lower end of the preparation container 200 is inserted into the receiving portion 303 of the inspection tool 300, the outer peripheral surface of the cylindrical portion 210 of the preparation container 200 is the inside of the cylindrical wall portion 331 of the inspection tool 300. The lower end side opening 221 of the preparation container 200 and the puncture needle insertion path 203 are positioned relative to the pointed end 334 b of the puncture needle 334 provided in the test instrument 300. It will be

  Further, after the pointed end portion 334 b of the puncture needle 334 passes the lower end opening 221, the pointed end portion 334 b of the puncture needle 334 faces the thin film portion 231 by being guided by the puncture needle insertion path 203. As a result, the thin film portion 231 is reliably pierced by the pointed end 334 b of the puncture needle 334.

  After piercing, since the main body portion 334a of the puncture needle 334 is in contact with the remaining portion of the thin film portion 231, the suspension 400 is prevented from leaking through the portion. Furthermore, since the annular projection 222 provided at the lower end side opening 221 of the preparation container 200 is in close contact with the main body 334 a of the puncture needle 334, a seal is also formed in this part, Even if there is a gap between the main body portion 334a of the puncture needle 334 and the remaining portion of the thin film portion 231, the suspension 400 is blocked by the relevant portion, and the suspension 400 leaks to the outside. It is prevented to put out.

  In addition, after piercing, the lower end of the preparation container 200 reaches the diameter-increased portion 333 provided in the needle portion 304 of the inspection tool 300 and abuts on this, so that the preparation container 200 described above As described above, a state in which the receiving unit 303 can not be inserted is realized.

  As described above, the inspection worker's work becomes easy, and the suspension 400 is introduced from the preparation container 200 to the inspection tool 300 in a substantially sealed state, so that the inspection worker can use virus and bacteria. There is no risk of airborne infections, and the test workers are not bothered by odors.

  In the above, the usage procedure in the case where these are delivered to the subject in a state in which the collecting instrument 100 is attached to the preparation container 200 in advance has been described, but the collecting instrument 100 and the preparation container 200 are separately It may be given to the subject. In such a case, the upper end side opening 211 of the preparation container 200 may be closed in advance by an aluminum seal or the like so that the sample dissolving buffer is prevented from leaking to the outside.

  FIG. 7 is a cross-sectional view of the test kit according to the present embodiment in the mounted state, and FIG. 8 is an enlarged view of a region VIII shown in FIG. Next, the configuration of the test kit according to the present embodiment in the mounted state will be described with reference to FIGS. 7 and 8.

  As shown in FIG. 7 and FIG. 8, in the test kit 1 in the mounted state according to the procedure described above, as described above, the puncture needle 334 provided in the test device 300 and the vicinity thereof are located. The main body portion 334a of the portion reaches the inside of the storage space 201 of the preparation container 200 (more specifically, the space above the portion where the thin film portion 231 was located), thereby providing the puncture needle 334. The hole 335 is also located inside the storage space 201.

  Therefore, the suspension 400 stored in the storage space 201 flows down to the flow path 307 provided in the inside of the puncture needle 334 via the hole 335, and the flowed down suspension 400 It reaches the filter 340 housed inside the enlarged diameter portion 333.

  Here, in the test kit 1 according to the present embodiment, as described above, the annular trap space 202 is provided so as to surround the projecting cylindrical portion 230 provided in the bottom portion 220 of the preparation container 200. There is. Therefore, as shown in FIG. 8, most of the residue 410 as a solid, which is a sample that has not been dissolved in the sample dissolving buffer, is attached to the preparation container 200 prior to being attached to the test instrument 300. By being allowed to stand for a while, it settles and precipitates in the trap space 202. As a result, most of the residue 410 is captured by the trap space 202, and movement of the residue 410 into the flow path 307 through the hole 335 can be suppressed.

  In addition, as described above, the thin film portion 231 has a thickness that causes breakage after being deformed to a considerable extent by being pressed by the pointed end portion 334b of the puncture needle 334 and plastic deformation, The majority of the residue 410 deposited on the upper portion also moves toward the trap space 202 according to the deformation, and also in this point, the residue 410 moves to the flow path 307 through the hole 335. Can be reduced.

  The suspension 400 having reached the filter 340 adheres to the one end of the test strip 350 disposed below the filter 340 by passing through the filter 340. At this time, the suspension 400 is filtered by the filter 340, whereby the residue 410 contained in the suspension 400 is captured by the filter 340.

  Here, due to the trapping function of the trap space 202 described above, the amount of the residue 410 reaching the filter 340 is significantly smaller than that in the case where the trap space 202 is not provided in the preparation container 200. Clogging can be effectively prevented by the residue 410. Therefore, the movement of the suspension 400 when passing through the filter 340 is promoted.

  The suspension 400 attached to the one end of the test strip 350 then spreads to the other part of the test strip 350, whereby the test strip 350 represents the test result, and the test result is a test device 300. It can be visually recognized from the outside through the window part 321 provided in

  As described above, by using the test kit 1 according to the present embodiment and the preparation container 200 provided therein, a sample that has not been dissolved in the sample dissolving buffer moves to the test instrument 300. Can be suppressed. Therefore, the filter 340 is not clogged, and the movement of the suspension 400 is promoted. Therefore, it is possible to prevent the occurrence of a defect such as a delay in inspection time or an inability to perform inspection itself, and it is possible to improve the efficiency of inspection work while securing the reliability of the inspection result.

  FIG. 9 is an enlarged perspective view of an essential part of a preparation container according to a modification based on the above-described present embodiment. Next, with reference to this FIG. 9, the structure of the preparation container which concerns on the modification based on this Embodiment is demonstrated.

  In the present embodiment described above, the inspection kit 1 including the preparation container 200 constituted by the annular space in which the trap space 202 is provided so as to surround the projecting cylindrical portion 230 has been exemplified, As shown in FIG. 9, the preparation container 200A included in the test kit according to the present modification differs only in that the configuration of the trap space 202 is different therefrom.

  Specifically, as shown in FIG. 9, the preparation container 200A has a plurality of partition parts 240 radially extending outward from the projecting cylindrical part 230 provided at the bottom part 220, An annular space provided to surround the cylindrical portion 230 is partitioned by the plurality of partition portions 240 along the circumferential direction. As a result, a plurality of trap spaces 202 partitioned in the circumferential direction are formed in the preparation container 200A.

  When configured in this way, in addition to the effects described in the above-described embodiment, not only the strength of the bottom portion 220 of the preparation container 200A can be improved, but the preparation container 200A is manufactured by injection molding In this case, the molten resin poured into the cavity of the mold can be well circulated, and in particular, the molten resin sufficiently spreads over the portion to be the thin film portion 231 of the cavity, which is favorable. Formability can be secured. Therefore, by using the preparation container 200A as in this modification and the inspection kit provided with the same, it can be preferable also from the viewpoint of manufacture.

  FIG. 10 is a cross-sectional view of an inspection device of an inspection kit according to another modification based on the above-described present embodiment. Next, with reference to FIG. 10, a test kit according to another modification based on the present embodiment will be described.

  As shown in FIG. 10, the test kit according to the present modification includes the above-described actual implementation only in that the test kit 300A having a configuration different from that of the above-described test device 300 (see FIG. 5 etc.) is provided. It differs from the test kit 1 which concerns on the form of. Here, as shown in FIG. 5, in the inspection instrument 300 described above, the test strip 350 is formed of a single chromatography filter paper folded in an L shape, and the test strip 350 is also included. One end portion of the inspection tool 300A is disposed immediately below the filter 340, but the inspection tool 300A according to this modification is different from the inspection tool 300 described above in these points.

  Specifically, as shown in FIG. 10, in the inspection instrument 300A, mainly the standing wall of the substantially L-shaped housing space 305 formed by combining the cover member 320 and the base member 330. The test strip 350 is disposed only in the vertically extending space, which is a portion located in the portion 302, and the horizontally extending space (located below the receiving space 306, which is a portion located in the pedestal portion 301 The test strip 350 is not disposed in the storage space provided inside the base portion 301 of the portion to be That is, in the inspection tool 300A, the test strip 350 is not bent and has an I-shaped side view.

  Here, the test strip 350 has a base pad extending in the vertical direction, a chromatography filter paper attached with a predetermined length at a predetermined position in the extending direction of the surface of the base pad, and an extending direction of the base pad And a plurality of pads attached to the surface of the base pad so as to connect with the chromatography filter in step (a) and (b) a portion of the portion facing the portion where the chromatography filter is located. By providing the window part 321 in the cover member 320, the chromatography filter paper is exposed to the outside. In addition, the lower end of the base member 330 is provided with a fastening portion 337 projecting toward the cover member 320, and one end (that is, the lower end) in the extension direction of the test strip 350 is provided to the fastening portion 337. The vertical position of the test strip 350 is achieved by the contact of the test strip 350.

  On the other hand, the accommodation space 305 extending in the horizontal direction, which is a portion positioned on the pedestal portion 301, and the accommodation space 305 extending in the vertical direction, which is a portion positioned on the standing wall portion 302, A liquid reservoir 305 a is provided at the lower end of the accommodation space 305 extending in the vertical direction, which communicates with the bypass wall and is a portion located in the standing wall 302. The lower end portion of the test strip 350 held to the holding portion 337 is positioned in the liquid storage portion 305 a, whereby the suspension 400 after passing through the filter 340 is positioned on the pedestal portion 301. It reaches the fluid reservoir 305 a via the horizontally extending receiving space 305 which is a part, and adheres to the lower end of the test strip 350 in the fluid reservoir 305 a.

  When configured in this way, in addition to the effects described in the above-described embodiment, the preparation container 200 and the collection tool 100 storing the suspension 400 inside the receiving unit 303 of the inspection tool 300A. It is possible to suppress the occurrence of variations between the time of insertion and the time when the test results appear on the test strip 350. That is, by adopting the above configuration, direct contact between the filter 340 and the test strip 350 is prevented, so that variations in the development of the suspension 400 based on the contact state can be prevented, and as a result, inspection It is possible to suppress the occurrence of variations in the time until the result appears in the test strip 350. Therefore, it becomes possible to conduct inspection more stably.

  In the embodiment of the present invention and the modifications thereof described above, by providing the protruding cylindrical portion at the center of the bottom of the preparation container, the trap space is positioned over the entire circumference of the protruding cylindrical portion. However, the trap space may be formed around the protruding cylindrical portion by eccentrically arranging the protruding cylindrical portion or changing the shape of the cylindrical portion surrounding the protruding cylindrical portion. It may be configured to be unevenly distributed to

  Further, in the embodiment of the present invention and the modification thereof described above, the case where the filter is installed in the inspection instrument has been exemplified, but the filter is not necessarily essential, and the above-described trap space In the case where the residue capturing function is sufficiently exerted and the residue hardly flows into the inspection instrument by this alone, the installation itself of the filter can be omitted.

  Further, in the embodiment of the present invention and the modification thereof described above, the test strip is exposed through the window portion provided in the cover member so that the inspection result can be visually recognized from the outside. Although illustrated, it may be configured such that a transparent film, a resin plate or the like is disposed in the window and the inspection result can be visually recognized from the outside while sealing the window.

  Further, in the embodiment of the present invention and the modifications thereof described above, a test kit using as a sample a stool that can be suitably used for clinical tests such as a fecal occult blood test and an infection test, and a preparation container included therein Although the case where the present invention is applied is described as an example, it is of course possible to apply the present invention to a test kit for clinical examination using specimens other than stool and a preparation container provided therein. It is also possible to apply the present invention to test kits other than those for clinical tests and preparation containers provided therein.

  Thus, the above-disclosed embodiments and the modifications thereof disclosed herein are illustrative and non-restrictive in every respect. The technical scope of the present invention is defined by the scope of the claims, and includes all the modifications within the meaning and scope equivalent to the description of the scope of the claims.

  1 test kit, 100 collection tools, 110 grips, 120 stoppers, 130 collars, 140 stems, 150 collectors, 200, 200 A preparation containers, 201 storage spaces, 202 trap spaces, 203 puncture needle insertion paths, DESCRIPTION OF SYMBOLS 210 Tubular part, 211 upper end side opening part, 212 1st latching projection, 213 2nd latching projection, 220 bottom part, 221 lower end side opening part, 222 annular projection, 230 projecting cylindrical part, 231 thin film part, 240 partitions Unit, 300, 300A Inspection instrument, 301 base, 302 standing wall, 303 receiving portion, 304 needle portion, 305 containing space, 305a reservoir, 306 receiving space, 307 flow path, 310 casing, 320 cover member, 321 Window, 330 base member, 331 cylindrical wall, 332 receiving opening, 333 enlarged diameter, 334 Puncture needle, 334a body, 334b pointed end, 335 hole, 336 hook, 337 clip, 340 filter, 350 test strip, 400 suspension, 410 residue.

Claims (3)

A collection tool for collecting a sample;
A buffer for sample dissolution is stored, and a suspension prepared by dissolving the sample collected by the collection tool in the sample dissolution buffer by storing the collection tool is stored. And a preparation container for
The preparation container is configured to be attachable, and the apparatus further comprises an inspection tool for inspecting a sample using a suspension introduced from the preparation container in a mounted state in which the preparation container is mounted.
The preparation container is internally provided with a storage space for storing a buffer for sample dissolution and a suspension,
The inspection instrument is provided with a puncture needle having therein a flow path for introducing a suspension from the preparation container in the mounted state,
The puncture needle is provided with a hole for communicating the storage space and the flow path in the mounted state,
At the bottom of the preparation container, a projecting cylindrical portion projecting toward the storage space, and an end of the projecting cylindrical portion close to the storage space are closed, and in the mounted state, the puncture needle A thin film portion to be opened is provided,
The storage space includes a trap space for capturing an analyte that has not been dissolved in the sample lysing buffer,
The trap space is an annular space provided adjacent to the projecting cylindrical portion in a direction intersecting the projecting direction of the projecting cylindrical portion so as to surround the projecting cylindrical portion .
The inspection kit which the partition part which divides the said trap space in the circumferential direction is provided in the said bottom part . The test kit according to claim 1, wherein the test device further includes a filter disposed downstream of the flow path and a test strip disposed downstream of the filter. A preparation container having a storage space provided therein for storing a suspension prepared by dissolving a sample in a sample lysis buffer,
It has a projecting cylindrical part which protrudes toward the storage space side, and a thin film part which closes an end of the projecting cylindrical part on the storage space side at its bottom;
The storage space includes a trap space for capturing an analyte that has not been dissolved in the sample lysing buffer,
The trap space is an annular space provided adjacent to the projecting cylindrical portion in a direction intersecting the projecting direction of the projecting cylindrical portion so as to surround the projecting cylindrical portion .
The container for preparation in which the partition part which divides the said trap space in the circumferential direction is provided in the said bottom part .

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