WO2017159616A1 - 検査容器及びそれを用いた検査方法 - Google Patents
検査容器及びそれを用いた検査方法 Download PDFInfo
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- WO2017159616A1 WO2017159616A1 PCT/JP2017/009986 JP2017009986W WO2017159616A1 WO 2017159616 A1 WO2017159616 A1 WO 2017159616A1 JP 2017009986 W JP2017009986 W JP 2017009986W WO 2017159616 A1 WO2017159616 A1 WO 2017159616A1
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- container
- adapter
- inspection
- test
- container body
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4055—Concentrating samples by solubility techniques
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
- B01L3/5082—Test tubes per se
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/04—Devices for withdrawing samples in the solid state, e.g. by cutting
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/405—Concentrating samples by adsorption or absorption
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/04—Closures and closing means
- B01L2300/041—Connecting closures to device or container
- B01L2300/042—Caps; Plugs
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
- B01L2300/0845—Filaments, strings, fibres, i.e. not hollow
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0848—Specific forms of parts of containers
- B01L2300/0851—Bottom walls
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
- B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/12—Specific details about materials
- B01L2300/123—Flexible; Elastomeric
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4055—Concentrating samples by solubility techniques
- G01N2001/4061—Solvent extraction
Definitions
- the present invention relates to an inspection container and an inspection method using the same. More specifically, the present invention relates to an inspection container that can easily inspect a plurality of items and an inspection method using the same.
- simple test reagents and kits have been developed that perform various tests in a short time, such as checking the presence or absence of pathogens such as viruses and bacteria, and checking the presence or absence of pregnancy.
- Many of the simple test reagents have the feature that they do not require special equipment and are easy to operate and inexpensive.
- simple test reagents for testing pathogen infection are widely used in general hospitals and clinics in addition to large hospitals and medical test centers. The reason for this is that these facilities are often the first medical institutions visited by patients, and it is possible to take treatment at an early stage if the presence or absence of infection is identified on the spot for specimens collected from patients. Therefore, the importance of simple test reagents in medicine is increasing.
- membrane assay methods using antigen-antibody reaction are generally known as measurement methods adopted for simple test reagents. Roughly divided into lateral flow assay methods.
- the former allows a solution containing an object to be detected to pass in the vertical direction with respect to the membrane, and the latter allows the solution to be developed in the horizontal direction.
- the latter includes a dipstick type.
- a complex of a capture substance that specifically binds to the detection target, a detection target, and a label that specifically binds to the detection target is formed on the solid phase, and the label is detected or quantified. Therefore, it is common in that the detection object is detected or quantified.
- a part is collected from the site where the detection target is expected to be present, and the sample is covered with a buffer solution or the like.
- a sample for membrane assay is prepared by suspending the detection substance. For example, a nasal cavity and a pharyngeal specimen used for a test for influenza and the like are collected from a patient's pharynx and nasal cavity using a specimen collection device such as a cotton swab and suspended in a buffer solution.
- the cotton balls are soaked in the sample extraction solution in the sample extraction container and eluted naturally. In general, it is discharged (see, for example, Patent Document 1).
- the inspection container according to any one of (1) to (4) comprising a hollow partition plate protruding from the bottom of the container body as the partition plate.
- a test kit comprising the test container according to any one of (1) to (5) and a test piece containing a sample extract.
- An inspection method comprising: a step of deforming a container by pressure from outside to squeeze a subject from a cotton swab; and a first impregnation step of impregnating a first test piece in a first chamber of the inspection container.
- the adapter further includes an inflow prevention plate that is provided so as to come into contact with the bottom of the container body from the container body side surface of the bottom corresponding to the boundary line of each chamber, and prevents the solution from flowing between the chambers.
- a test kit comprising the test container according to any one of (10) to (18) and a test piece containing a specimen extract.
- an inspection container that can easily inspect a plurality of items with a plurality of test pieces is provided.
- FIG. 1A is a partially cutaway perspective view of an inspection container 1A according to the embodiment, and FIG. 1B is a top view thereof.
- FIG. 2A is a partially cutaway perspective view of a cuvette 2A according to the embodiment, and FIG. 2B is a top view thereof.
- FIG. 3A is a partially cutaway perspective view of a cuvette 3A according to the embodiment, and FIG. 3B is a top view thereof.
- FIG. 4A is a partially cutaway perspective view of a cuvette 4A according to the embodiment, and FIG. 4B is a top view thereof.
- FIG. 5A is a partially cutaway perspective view of an inspection container 5A according to the embodiment, and FIG. 5B is a top view thereof.
- FIG. 6A to 6E are process diagrams of the inspection method 1A according to the embodiment.
- 7E to 7G are process diagrams of the inspection method 2A according to the embodiment.
- FIG. 8A is a partially cutaway perspective view of a cuvette 1B according to the embodiment, and FIG. 8B is a top view thereof.
- 9A is a cross-sectional view taken along line AA of the cuvette 1B according to the embodiment, and
- FIG. 9B is a cross-sectional view taken along line BB.
- 10A is a top view of a modified example of the cuvette 1B according to the embodiment
- FIG. 10B is an AA cross-sectional view
- FIG. 10C is a BB cross-sectional view.
- FIG. 11A is a partially cutaway perspective view of a cuvette 2B according to the embodiment, FIG. 11B is a top view thereof, and FIG. 11C is a cross-sectional view along AA.
- FIG. 12A is a partially cutaway perspective view of a cuvette 3B according to the embodiment, and FIG. 12B is a top view thereof.
- FIG. 13A is a partially cutaway perspective view of a cuvette 4B according to the embodiment, and FIG. 13B is a top view thereof.
- 14A to 14F1 are process diagrams of the inspection method 1B according to the embodiment.
- 15F2 to 15H are process diagrams of the inspection method 2B according to the embodiment.
- FIG. 16 is a process diagram of the inspection method B.
- FIG. 1A is a partially cutaway perspective view of a cuvette according to an embodiment of the present invention
- FIG. 1B is a top view thereof.
- a test container 1A includes a flexible container body 10 having a bottomed hollow shape, and a partition projecting from the bottom 10d of the container body 10 along the axial direction inside the container body 10. And a plate 11.
- the partition plate 11 separates the bottom surface side of the specimen extract storage part 50 of the container body 10 into a first chamber 51 and a second chamber 52, so that a first containing the same specimen extract is stored.
- a first test piece and a second test piece can be inserted into the chamber 51 and the second chamber 52, respectively. Therefore, according to the test container 1A, for the same sample extract placed under the same conditions, (1) the first and second test pieces can be tested for different items substantially simultaneously, or (2) the first After the inspection with the test piece, the effect of being able to appropriately inspect another item with the second test piece is obtained.
- the material of the container body 10 is held by a water-absorbing member such as a cotton ball which is deformed by an external pressure when the test container is used and is inserted into the test container without affecting the specimen extract contained therein.
- a water-absorbing member such as a cotton ball which is deformed by an external pressure when the test container is used and is inserted into the test container without affecting the specimen extract contained therein.
- a flexible material specifically, a resin material such as polyethylene, polystyrene, polypropylene, silicon rubber, thermoplastic elastomer, and vinyl chloride can be used.
- you may adjust those elastic moduli suitably by a well-known method.
- the container body 10 is preferably transparent or translucent from the viewpoint of easily grasping the state of the inside of the test container when a sample is squeezed from a cotton ball or the like or when a test piece is inserted.
- the container body 10 is not particularly limited, and is preferably integrally formed by various methods such as injection molding or 3D printer. The same applies to
- the shape of the test container 1A which will be described later, is a hollow shape with a bottom, and is not particularly limited as long as it has an appropriate size and shape for containing the sample extract and soaking the cotton swab, but is independently held vertically. Such a structure is desirable. Examples of such a shape include a cylindrical column, a rectangular column such as a quadrangular column, a hexagonal column, and the like, and the container main body includes the same cross-sectional structure or a structure having a taper in part from the upper part to the lower part.
- test container 1A which will be described later, 1B has an opening at one end so as to accommodate the sample extract, and the opening is provided at the upper part of the container and can be sealed with a lid or a seal. It is desirable to be.
- a screwing portion 10 a in the opening of the container body 10. This is because, after the specimen extract is filled in the test container in advance, a cap is detachably fitted, and the cap is removed at the time of use, so that the test can be easily performed.
- the inspection container 1A and 1B described later may further be provided with a non-slip structure on the outer wall portion as necessary.
- a rotational force is applied to the inspection container 1A by inserting a cotton swab into the inspection container 1A and 1B described later and pressing the cotton ball against the container wall surface, it can be supported to suppress rotation.
- the inspection container 1 ⁇ / b> A which will be described later, 1 ⁇ / b> B, may be provided with a substantially square-shaped rib 10 b on the outer periphery of the container at the boundary between the screwing portion 10 a and the container body 10. This is because the cuvette 1A and the later-described 1B can be prevented from rolling, and can prevent slipping when the cap is opened and closed.
- the height X of the partition plate 11 is less than 2, preferably 1.8 or less, more preferably 1.7 or less, and 1. Even more preferred is 6 to 1.0.
- the specimen to be analyzed using the test container 1A and 1B to be described later is not particularly limited, and biological samples such as whole blood, serum, plasma, urine, saliva, sputum, nasal discharge, nasal cavity or throat swab, sweat, feces, etc.
- biological samples such as whole blood, serum, plasma, urine, saliva, sputum, nasal discharge, nasal cavity or throat swab, sweat, feces, etc.
- extracts from foods such as meat and plants, samples derived from environments such as sewage, mud, and soil, microorganism culture solutions or suspensions such as bacteria and viruses, and extracts from bacteria and viruses are included.
- the detected substance in the specimen is not particularly limited, but in the field of clinical examination, for example, it is an antigen or an antibody.
- a protein derived from a virus such as influenza virus, RS virus, adenovirus, human metapneumovirus, etc. And antigen.
- the specimen absorbed with a cotton ball or the like may be squeezed out using a test container and supplied directly to the specimen supply site without being diluted.
- a sample that cannot be easily deployed and moved on the solid support due to the viscosity of the sample may be diluted with a sample extract in advance and supplied to the detection device.
- the sample extract may be acidic, neutral, or basic as long as the analyte can be developed on the solid support to the extent that there is no problem in the detection process.
- various buffer solutions containing a surfactant, a denaturant and the like may be used, and solutions having any composition may be used.
- the member impregnating the specimen may be any member as long as the specimen is absorbed and can be extracted into the specimen extraction solution.
- a cotton swab or a cotton ball can be used.
- cotton swabs and cotton balls in the field of clinical examination, when samples are collected from humans, sterilized cotton swabs or cotton balls are often used for hygiene purposes.
- the material is not particularly limited as long as it has water absorption similar to that of cotton balls and has no problem in terms of hygiene.
- chemical fiber materials such as cotton, pulp and rayon can be used.
- the specimen extract storage part 50 of the container body 10 may be partitioned into three chambers. Thereby, for example, RS virus, adenovirus, and human metapneumovirus can be tested simultaneously using the same specimen extract.
- the specimen extract storage part 50 of the container body 10 may be divided into four chambers. For example, four types of inspections can be performed at the same time, or after three types of inspections, those having poor sensitivity can be reinspected.
- the specimen extraction liquid storage unit 50 may be a multi-compartment room such as five rooms, six rooms, seven rooms,.
- the partition plate 41 may be detachably fixed inside the container body 10 by a locking portion 41a (hollow ring) that can be locked inside the container body 10.
- locking part 41a is arrange
- the locking part 41a may be partially missing without going around the inner periphery.
- a part of the hollow ring may be missing so as to have an approximately Roman letter “I” or “H” shape when viewed from above.
- a plate-shaped partition plate is arranged in the cuvettes 1A to 4A.
- the configuration is not limited to this as long as the specimen extractant storage section 50 of the container body 10 is partitioned into a plurality of sections.
- a hollow cylindrical partition plate 81 may be protruded from the bottom 10 d of the container body 10.
- the shape of the partition plate 81 is a hollow body having a circular shape when viewed from the top as shown in FIG. 5B, but is not limited thereto, and may be a hollow body having a polygonal shape such as a triangle or a square when viewed from the top.
- a hollow partition plate having the same shape as that of the partition plate 81 may be further arranged inside the partition plate 81 in a concentric manner so that the specimen extract solution storage section 50 may be partitioned into a plurality of parts. Further, a partition plate that further partitions the partition plate 81 into two or more chambers may be arranged to divide the specimen extract solution storage section 50 into a plurality of sections. The height of the partition plate 81 may be configured to be the same as that of the cuvette 1A.
- FIG. 1A a flexible cuvette 1A in which the inside of the cuvette is partitioned into two chambers along the axial direction is prepared, and the cuvette 1A is preliminarily filled with a specimen extract.
- the cap of the test container 1A is removed as shown in FIG. 6A, and then, as shown in FIG. 6B, a cotton swab that has absorbed the subject is impregnated in the test container filled with the sample extract. Then, as shown in FIG. 6C, the swab is rotated left and right about the rod axis.
- a cotton ball of a cotton swab may be pressed against the inner wall of the container.
- the test container is deformed by pressure from the outside, and the subject is squeezed out from the swab so as to rub the cotton balls against the inner wall of the container.
- the first test piece 61 is inserted into the first chamber 51 of the cuvette and the second test piece 62 is inserted into the second chamber 52.
- the first test piece 61 and the second test piece 62 can be used to test different items substantially simultaneously.
- inspection method 2A since inspection can be performed from inspection items having a high possibility of being inspected, and inspection of other items can be appropriately performed according to the inspection result, rather than a case where inspection is performed substantially simultaneously on a plurality of items, It is economical because inspection items can be omitted.
- inspection containers 1A to 4A have been mainly described, according to the present invention, for example, an inspection kit including the above-described inspection container is also provided.
- the test kit includes a test container for storing the sample extract and a test piece.
- a plurality of test pieces can be provided as test pieces.
- a test piece capable of inspecting a plurality of items with a single test piece can also be used.
- the specimen extract in the second chamber 52 is supplied to various test devices to detect the object to be detected. Also good.
- the present invention can be applied to various inspection methods such as a dipstick method in which a test piece is inserted into an inspection container and immersed in an extract, a lateral flow method in which the extract is supplied to a test device, and a flow-through method.
- the present invention naturally includes various embodiments not described herein. Therefore, the technical scope of the present invention is defined only by the invention specifying matters according to the scope of claims reasonable from the above description.
- Example 1A Using polyethylene as a molding material, an inspection container 1A shown in FIGS. 1A and 1B was prepared by injection molding. Thereafter, an experiment was performed according to the procedure of the inspection method 1A described above. At that time, RS virus, adenovirus, and rotavirus positive specimens were used as specimens, rapid tester (registered trademark) RSV-adeno (manufactured by Sekisui Medical) as the first test piece, and rapid tester (second test piece) A test piece of (registered trademark) Rota-Adeno (manufactured by Sekisui Medical) was used. As a result, both the first and second test pieces could be inspected satisfactorily.
- Example 1A A test container having the same configuration as that shown in FIGS. 1A and 1B was prepared except that the partition plate 11 was not provided, and an experiment similar to that in Example 1A was performed. As a result, the first test piece and the second test piece crossed, and a flow failure occurred in the second test piece.
- Example 2A Using polyethylene as a molding material, an inspection container 1A shown in FIGS. 1A and 1B was prepared by injection molding. Thereafter, an experiment was performed according to the procedure of the above-described inspection 2A. At that time, RS virus, adenovirus, and rotavirus positive specimens were used as specimens, rapid tester (registered trademark) RSV-adeno (manufactured by Sekisui Medical) as the first test piece, and rapid tester (second test piece) A test piece of (registered trademark) Rota-Adeno (manufactured by Sekisui Medical) was used. As a result, both the first and second test pieces could be inspected satisfactorily.
- Example 2A A cuvette having the same configuration as that shown in FIGS. 1A and 1B was prepared except that the partition plate 11 was not provided, and an experiment similar to that in Example 2A was performed. As a result, since the first test piece completely absorbed the specimen extract, another item could not be inspected by the second test piece.
- FIG. 8A is a partially cutaway perspective view of a cuvette according to an embodiment of the present invention
- FIG. 8B is a top view thereof.
- the cuvette 1B includes a flexible container body 10 having a bottomed hollow shape, and a bottomed hollow adapter 8 that is detachably fixed inside the container body 10.
- the adapter 8 has a partition plate 81 that is provided facing the opening from the bottoms 8d and 8e (first surface) of the adapter 8 and divides the specimen extract storage part 50 of the adapter into two or more chambers. As shown in FIG.
- the first containing the same specimen extract is stored.
- a first test piece and a second test piece can be inserted into the chamber 51 and the second chamber 52, respectively. Therefore, according to the test container 1B, for the same sample extract placed under the same conditions, (1) the first and second test pieces can be tested for different items substantially simultaneously, or (2) the first After the inspection with the test piece, the effect of being able to appropriately inspect another item with the second test piece is obtained.
- the adapter 8 preferably has guides 8 a and 8 b extending to the opening of the adapter 8 on the extension line of the boundary line between the chambers inside the adapter 8. This is because when the test piece is inserted into the container, the boundary between the chambers can be easily seen. Moreover, it is because it can prevent falling down to the other chamber side because a test piece is latched by a guide.
- the guides 8 a and 8 b are arranged so that the upper ends of the openings of the guides 8 a and 8 b You may form so that it may arrange
- the adapter 8 is preferably formed with a through hole, preferably a pore, at the bottom of any of the two or more chambers.
- a through hole is formed at the bottom of at least one of the plurality of chambers. It is preferable not to provide it.
- the material of the adapter 8 is not particularly limited as long as it does not affect the specimen extract to be accommodated.
- a flexible material specifically, a resin material such as polyethylene, polystyrene, polypropylene, silicon rubber, thermoplastic elastomer, and vinyl chloride can be used.
- the height X of the partition plate 81 of the adapter is less than 2, preferably 1.8 or less, more preferably 1.7 or less, when the height Y of the specimen extract storage part 50 of the container body 10 is 2. Even more preferred is 1.2 to 0.5.
- the sample extract is stirred well to obtain a sample extract with an equal concentration of the sample, but the adapter 8 is inserted into the container body 10 Then, in order to prevent the concentration gradient for each chamber from being generated, the adapter partition plate 81 may be provided with a communication hole so that the adjacent chamber and the sample extract can communicate with each other.
- FIG. 10A is a top view of a modified example of the cuvette 1 according to the embodiment
- FIG. 10B is an AA cross-sectional view
- FIG. 10C is a BB cross-sectional view
- 8A has a configuration in which no through hole is provided at the bottom of the second chamber 52 in order to prevent the sample extract from flowing from the second chamber 52 into the first chamber 51.
- the method for preventing the inflow of the specimen extract is not limited to this. For example, as shown in FIG.
- an inflow prevention plate 8g that prevents inflow of the solution between the chambers may be provided so as to be in contact with the bottom (third surface) of the container body 10.
- the adapter 8 is provided with a through hole at the bottom, but the present invention is not limited thereto, and a through hole may be provided in a part of the adapter 8, for example, a side wall.
- the adapter 8 has a bottomed hollow shape, the bottom may not be provided as long as a partition plate is disposed inside the adapter 8 and can be held by the side wall.
- the specimen extract storage part 50 of the container body 10 may be partitioned into three chambers. Thereby, for example, RS virus, adenovirus, and human metapneumovirus can be tested simultaneously using the same specimen extract.
- the bottom of the adapter 8 is placed so that the bottom of the adapter 8 is in close contact with the bottom of the container body. May be configured.
- the specimen extract storage part 50 of the container body 10 may be divided into four chambers.
- the specimen extraction liquid storage unit 50 may be a multi-compartment room such as five rooms, six rooms, seven rooms,.
- a plate-like partition plate is arranged in the cuvettes 1B to 3B.
- the configuration is not limited to this as long as the specimen extract liquid storage unit 50 is partitioned into a plurality of sections.
- a hollow cylindrical partition plate 84 may be protruded from the bottom 8 d of the adapter 8.
- the shape of the partition plate 84 is a hollow body having a circular shape in a top view as shown in FIG. 13B, but is not limited thereto, and may be a hollow body having a polygonal shape such as a triangle or a square in a top view.
- a hollow partition plate having the same shape as that of the partition plate 84 may be further arranged concentrically inside the partition plate 84 to partition the sample extraction liquid storage unit 50 into a plurality of sections. Further, a partition plate that further partitions the partition plate 84 into two or more chambers may be arranged to divide the specimen extract solution storage section 50 into a plurality of sections. The height of the partition plate 84 may be configured to be the same as that of the cuvette 1.
- FIGS. 8A and 14A to 14F1 The steps of the inspection method according to the embodiment will be described with reference to FIGS. 8A and 14A to 14F1.
- a flexible container body 10 having a bottomed hollow shape as shown in FIG. 8A is prepared, and a specimen extract is filled in the container body 10 in advance.
- the cap of the container body 10 is removed as shown in FIG. 14A, and then, as shown in FIG. 14B, the cotton swab 101 that has absorbed the subject is impregnated in the container body 10 filled with the specimen extract 100.
- the swab 101 is rotated left and right about the rod axis. At that time, the cotton ball of the swab 101 may be pressed against the inner wall of the container. Thereafter, as shown in FIG. 14D, the container body 10 is deformed by external pressure, and the subject is squeezed out from the cotton swab 101 so as to rub the cotton balls against the inner wall of the container. Then, as illustrated in FIG. 14E, the adapter 8 is inserted into the container body 10. It is preferable to insert the adapter 8 slowly so that the sample extract moves into the adapter 8 through a through hole provided in the bottom of the adapter 8. As shown in FIG.
- the first test piece 61 and the second test piece 62 are inserted into the first chamber 51 and the second chamber 52 of the cuvette 1B, respectively.
- the first test piece 61 and the second test piece 62 can be used to test different items substantially simultaneously.
- the subject can be squeezed more efficiently because there is no partition plate in the step of squeezing the subject from the cotton swab in FIG. 14D.
- the adapter 8 when the adapter 8 is inserted into the container body 10, even if there is a sample suspension adhering to the wall surface of the container body 10, it can be collected from the wall surface. The effect that the sample amount (liquid amount) required for the measurement can be more sufficiently secured in the two chambers 52 is obtained.
- the outer periphery of the adapter 8 and the inner periphery of the container body 10 are in close contact with each other.
- the outer radius of the adapter 8 is greater than or equal to the inner radius of the container body 10. Even if the outer radius of the adapter 8 is slightly larger than the inner radius of the container body 10, the outer periphery of the adapter 8 is in close contact with the inner periphery of the container body 10 by using a flexible flexible container as the container body 10. Thus, the adapter 8 can be introduced into the container body 10.
- the outer radius of the adapter 8 is preferably equal to or greater than the inner radius of the container body 10.
- the inspection method 2B it is possible to inspect from inspection items having a high possibility, and to appropriately inspect other items according to the inspection result. Therefore, the inspection items can be omitted as compared with the case of inspecting a plurality of items at the same time, which is economical.
- the inspection containers 1B to 4B have been mainly described, according to the present invention, for example, an inspection kit including the above-described inspection container is also provided.
- the test kit includes a test container for storing the sample extract and a test piece.
- a plurality of test pieces can be provided as test pieces.
- a test piece capable of inspecting a plurality of items with a single test piece can also be used.
- the specimen extract in the second chamber 52 is supplied to various test devices to detect an object to be detected. Also good.
- the present invention can be applied to various inspection methods such as a dipstick method in which a test piece is inserted into an inspection container and immersed in an extract, a lateral flow method in which an extract is supplied to a test device, and a flow-through method.
- the present invention naturally includes various embodiments not described herein. Therefore, the technical scope of the present invention is defined only by the invention specifying matters according to the scope of claims reasonable from the above description.
- Example 1B A test container 1B shown in FIGS. 8A and 8B was prepared by injection molding using polyethylene as a molding material. Thereafter, an experiment was performed according to the procedure of the inspection method 1B described above. At that time, RS virus, adenovirus, and rotavirus positive specimens were used as specimens, rapid tester (registered trademark) RSV-adeno (manufactured by Sekisui Medical) as the first test piece, and rapid tester (second test piece) A test piece of (registered trademark) Rota-Adeno (manufactured by Sekisui Medical) was used. As a result, both the first and second test pieces could be inspected satisfactorily.
- Example 1B Except for the absence of the partition plate 11, a test container having the same configuration as in FIGS. 8A and 8B was prepared, and the same experiment as in Example 1B was performed. As a result, the first test piece and the second test piece crossed, and a flow failure occurred in the second test piece.
- Example 2B A test container 1B shown in FIGS. 8A and 8B was prepared by injection molding using polyethylene as a molding material. Thereafter, an experiment was performed according to the procedure of the above-described inspection 2B. At that time, RS virus, adenovirus, and rotavirus positive specimens were used as specimens, rapid tester (registered trademark) RSV-adeno (manufactured by Sekisui Medical) as the first test piece, and rapid tester (second test piece) A test piece of (registered trademark) Rota-Adeno (manufactured by Sekisui Medical) was used. As a result, both the first and second test pieces could be inspected satisfactorily.
- Example 2B Comparative Example 2B Except that the partition plate 11 is not provided, a cuvette having the same configuration as in FIGS. 8A and 8B was prepared, and an experiment similar to that in Example 2B was performed. As a result, since the first test piece completely absorbed the specimen extract, another item could not be inspected by the second test piece.
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Abstract
Description
綿棒の綿球に吸収された被検出物を綿棒外に排出するには、検体抽出容器内の検体抽出液に綿球を浸し、自然に溶出する他、外部から綿球に圧力をかけ、強制的に排出させるのが一般的である(例えば、特許文献1参照)。
そのため、複数の試験片で複数項目の検査を簡易に行える検査容器が求められていた。
(2)仕切板は、前記容器本体と一体に前記容器本体の底部から凸設している、(1)に記載の検査容器。
(3)容器本体の検体抽出液収容部は3以上の室に区画されている、(1)又は(2)に記載の検査容器。
(4)仕切板は、係止部により前記容器本体の内部に着脱自在に固定されている、(1)~(3)のいずれか1に記載の検査容器。
(5)仕切板として、前記容器本体の底部から凸設した中空形状の仕切板を備える、(1)~(4)のいずれか1に記載の検査容器。
(6)検体抽出液を収納した(1)~(5)のいずれか1に記載の検査容器と、試験片と、を備える検査キット。
(7)容器の内側が軸方向に沿って2以上の室に区画された可撓性の検査容器内に収容された検体抽出液に、被検体を吸収した綿棒を含漬させる工程と、検査容器を外部から圧力により変形させて、綿棒から被検体を絞り出す工程と、検査容器の第一室に第一試験片を含漬させる第一含漬工程と、を備える検査方法。
(8)検査容器の第二室に第二試験片を含漬させる第二含漬工程をさらに備える、(7)に記載の検査方法。
(9)第二含漬工程は、第一含漬工程と略同時、または第一含漬工程の後に行われる、(8)に記載の検査方法。
(10)有底中空形状をした可撓性の容器本体と、容器本体の内部に着脱自在に固定された有底中空形状のアダプターと、を備え、アダプターは、アダプターの底部から開口部側に向かい設けられた、アダプターの検体抽出液収容部を2以上の室に区画する仕切板を有する検査容器。
(11)アダプターは、その一部に貫通孔が形成されている(10)に記載の検査容器。
(12)アダプターは、2以上の室の少なくとも1つの底部に貫通孔が形成されている(10)に記載の検査容器。
(13)アダプターは、アダプターの内側における各室の境界線の延長線上にアダプターの開口部まで至るガイドを有する(10)~(12)のいずれか1に記載の検査容器。
(14)ガイドは、ガイドの開口部上端が、容器本体の開口部の縁よりも高く配置される(13)に記載の検査容器。
(15)ガイドは、ガイドの開口部上端から、検査容器の外側に向かい張り出すつば部を有する(14)に記載の検査容器。
(16)アダプターは、各室の境界線に対応する底部の容器本体側表面から容器本体の底部に当接するように設けられた、各室間の溶液の流入を防止する流入防止板をさらに有する(10)~(15)のいずれか1に記載の検査容器。
(17)アダプター本体の検体抽出液収容部は3以上の室に区画されている(10)~(16)のいずれか1に記載の検査容器。
(18)アダプターの外側半径は、容器本体の内法半径以上である(10)~(17)のいずれか1に記載の検査容器。
(19)検体抽出液を収納した(10)~(18)のいずれか1に記載の検査容器と、試験片と、を備える検査キット。
(20)有底中空形状をした可撓性の容器本体に収容された検体抽出液に、被検体を吸収した綿棒を含漬させる工程と、容器本体を外部から圧力により変形させて、綿棒から被検体を絞り出す工程と、有底中空形状のアダプター本体、アダプター本体の底部から開口部側に向かい設けられたアダプター本体の検体抽出液収容部を2以上の室に区画する仕切板を備え、2以上の室の少なくとも1つの底部に貫通孔が形成されたアダプターを容器本体の内部に挿入する工程と、2以上の室のうちの第一室に第一試験片を含漬させる第一含漬工程と、を備える検査方法。
(21)2以上の室のうちの第二室に第二試験片を含漬させる第二含漬工程をさらに備える(20)に記載の検査方法。
(22)第二含漬工程は、第一含漬工程と略同時、または第一含漬工程の後に行われる(21)に記載の検査方法。
[検査容器1A]
図1Aは本発明の実施形態にかかる検査容器の一部切欠き斜視図であり、図1Bはその上面図である。図1Aに示すように、検査容器1Aは、有底中空形状をした可撓性の容器本体10と、容器本体10の内側に軸方向に沿って、容器本体10の底部10dから凸設した仕切板11と、を備える。
そのため、検査容器1Aによれば、同一条件下に置かれた同一検体抽出液について、(1)第一、第二試験片により、それぞれ別項目の検査を略同時に行える、又は(2)第一試験片による検査の後に、第二試験片により別項目の検査を適宜行える、といった作用効果が得られる。
綿球等から検体を搾り出す際や、試験片を挿入する際に、検査容器内部の様子を把握しやすい観点からは、容器本体10は透明または半透明であることが好ましい。
容器本体10は、特に制限されることなく、種々の方法、例えば、射出成形や3Dプリンター等により一体成形さることが好ましい。なお、後述のアダプター8についても同様である。
また、検査容器1A、後述の1Bは、検体抽出液を収容可能なように一端に開口部を有するが、開口部は、容器の上部に設けられ、密閉可能に蓋もしくはシールを取り付けられる構造であることが望ましい。例えば図1Aに示すように、容器本体10の開口部に螺合部10aを設けておくことが好ましい。検査容器内に予め検体抽出液を充填した後に、取り外し可能にキャップを嵌め、使用時にキャップを取り外すことで、簡易に検査を行なうことができるからである。
検査容器1A内に収容された検体抽出液に検体を溶出した後、検体抽出液をよく攪拌することで、検体の濃度が均等な検体抽出液が得られるが、各室毎の濃度勾配が生じることを防止するため、仕切板には、隣接する室と検体抽出液が連通可能に、連通穴を設けてもよい。
検体抽出液は、被検出物が検出工程上、支障がない程度に固相支持体上を展開できれば、その液性については酸性、中性、塩基性を問わない。また、界面活性剤、変性剤等を含む各種緩衝液でも、いかなる組成の溶液でもよい。
なお、上記の綿棒や綿球などについては、臨床検査の分野で、ヒトなどから検体を採取する場合には、衛生面から滅菌消毒された綿棒もしくは綿球が使用されることが多いが、これに限定されるものではなく、綿球類似の吸水性を有し、衛生面等で問題なければ、その材質は特に限定されない。例えば、綿、パルプ、レーヨン等の化学繊維性のものなども使用できる。
図1A,図1Bを用いて、本発明について説明したが、本発明は上述の発明に限定されることはない。例えば、図2A,図2Bに示すように、容器本体10の検体抽出液収容部50が3室に区画されていてもよい。これにより、同一の検体抽出液を用いて、例えば、RSウィルス、アデノウィルス、ヒトメタニューモウィルスの検査を同時に行なうことができる。また図3A,図3Bに示すように、容器本体10の検体抽出液収容部50が4室に区画されていてもよい。例えば、4種の検査を同時に行ったり、3種の検査をした後に感度が悪いものについて再検査することができる。また、検体抽出液収容部50が5室、6室、7室、・・・と多区画室となっていてもよい。
検査容器1A~4Aにおいては板状の仕切板を配置する構成としたが、容器本体10の検体抽出液収容部50が複数に区画されるのであればこれに限定されることはない。例えば、図5Aに示すように、中空円筒状の仕切板81を容器本体10の底部10dから凸設させる構成としてもよい。ここでは仕切板81の形状を、図5Bに示すように上面視円状の中空体としたがこれに限定されることなく、上面視三角、四角といった多角形状の中空体としてもよい。また仕切板81の内側に同心円状に、仕切板81と同様の形状をした中空状の仕切板をさらに配置して、検体抽出液収容部50を複数に区画してもよい。また仕切板81を更に2室以上に仕切る仕切板を配置して、検体抽出液収容部50を複数に区画してもよい。仕切板81の高さは検査容器1Aと同様の高さに構成してもよい。
実施形態に係る検査方法の工程について、図1A、図6A~図6Eを用いて説明する。
まず図1Aに示すような、容器の内側が軸方向に沿って2室に区画された可撓性の検査容器1Aを用意し、検査容器1A内に検体抽出液を予め充填しておく。
使用時に、図6Aに示すように検査容器1Aのキャップを取り除き、その後図6Bに示すように、検体抽出液が充填された検査容器内に被検体を吸収した綿棒を含漬させる。
そして、図6Cに示すように、綿棒を棒軸を中心にして左右に回転させる。その際、綿棒の綿球を容器内壁に押し付けるようにしてもよい。
その後、図6Dに示すように、検査容器を外部からの圧力により変形させて、容器内壁に綿球を擦り付けるように綿棒から被検体を絞り出す。
図6Eに示すように、検査容器の第一室51に第一試験片61、第二室52に第二試験片62を挿入する。
このように、検査方法1Aによれば、同一条件下に置かれた同一検体抽出液について、第一試験片61と第二試験片62により、それぞれ別項目の検査を略同時に行える。
上述の検査方法1Aにおいては、図6A~図6Dの工程の後、図6Eに示すように、第一試験片61と第二試験片62を、それぞれ第一室51、第二室52略同時に挿入した。しかし、図6Eの工程に換えて、図7Eに示すように、第一室51に第一試験片61を挿入してもよい。これにより、図7Fに示すように、第一室51内の検体抽出液が第一試験片61に吸収され尽くした後でも、図7Gに示すように、第二室52に第二試験片62を挿入することで、別項目の検査を行なうことができる。
このように、検査方法2Aによれば、該当可能性の高い検査項目から検査し、その検査結果に応じて別項目の検査を適宜行えるため、複数の項目について略同時に検査を行なう場合よりも、検査項目を省略できるので経済的である。
上記のように、本発明は実施形態によって記載したが、この開示の一部をなす論述及び図面はこの発明を限定するものであると理解すべきではない。この開示から当業者には様々な代替実施の形態、実施例及び運用技術が明らかとなろう。
検査容器1A~4Aについて中心に説明してきたが、本発明によれば、例えば、上述の検査容器を備える検査キットも提供される。検査キットとしては、検体抽出液を収納する検査容器と、試験片と、を備える。試験片として、複数の試験片を備えることができる。一片の試験片で複数の項目を検査できる試験片を用いることもできる。
検査方法1A,2Aについて説明したが、検査方法2Aに係る図7E、図7Fの工程の後、第二室52内の検体抽出液を各種テストデバイスに供給して、被検出物を検出してもよい。例えば、試験片を検査容器に挿入し、抽出液に浸すディップスティック式、抽出液をテストデバイスへと供給するラテラルフロー式、フロースルー式の各種検査方法に適用することができる。
このように、本発明はここでは記載していない様々な実施の形態等を含むことは勿論である。したがって、本発明の技術的範囲は上記の説明から妥当な特許請求の範囲に係る発明特定事項によってのみ定められるものである。
成形材料としてポリエチレンを用いて、射出成形により図1A、図1Bに示す検査容器1Aを調製した。その後、上述の検査方法1Aの手順に従って実験を行った。その際、被検体としてRSウィルス、アデノウィルス、ロタウィルス陽性検体を用い、第一試験片としてラピッドテスタ(登録商標)RSV-アデノ(積水メディカル社製)の試験片、第二試験片としてラピッドテスタ(登録商標)ロタ-アデノ(積水メディカル社製)の試験片を用いた。その結果、第一、第二試験片ともに、良好に検査を行なうことができた。
仕切板11がないことを除いて、図1A,図1Bと同様の構成を備える検査容器を調製し、実施例1Aと同様の実験を行なった。その結果、第一試験片と第二試験片とが交差し、第二試験片に流れ不良が生じた。
成形材料としてポリエチレンを用いて、射出成形により図1A、図1Bに示す検査容器1Aを調製した。その後、上述の検査2Aの手順に従って実験を行った。その際、被検体としてRSウィルス、アデノウィルス、ロタウィルス陽性検体を用い、第一試験片としてラピッドテスタ(登録商標)RSV-アデノ(積水メディカル社製)の試験片、第二試験片としてラピッドテスタ(登録商標)ロタ-アデノ(積水メディカル社製)の試験片を用いた。その結果、第一、第二試験片ともに、良好に検査を行なうことができた。
仕切板11がないことを除いて、図1A,図1Bと同様の構成を備える検査容器を調製し、実施例2Aと同様の実験を行なった。その結果、第一試験片が検体抽出液を吸収し尽くすために、第二試験片により別項目の検査を行えなかった。
上述の第一の実施形態との相違点を中心に第二の実施形態について説明する。
[検査容器1B]
図8Aは本発明の実施形態にかかる検査容器の一部切欠き斜視図であり、図8Bはその上面図である。図8Aに示すように、検査容器1Bは、有底中空形状をした可撓性の容器本体10と、容器本体10の内部に着脱自在に固定された有底中空形状のアダプター8と、を備える。アダプター8は、アダプター8の底部8d、8e(第一面)から開口部側に向かい設けられた、アダプターの検体抽出液収容部50を2以上の室に区画する仕切板81を有する。
図8Aに示すように、仕切板81により容器本体10の検体抽出液収容部50の底面側が第一室51と第二室52に区画されているため、同一の検体抽出液を収容する第一室51、第二室52に、それぞれ第一試験片、第二試験片を挿入できる。
そのため、検査容器1Bによれば、同一条件下に置かれた同一検体抽出液について、(1)第一、第二試験片により、それぞれ別項目の検査を略同時に行える、又は(2)第一試験片による検査の後に、第二試験片により別項目の検査を適宜行える、といった作用効果が得られる。
各室の境界をより目視しやすくするためには、例えば、ガイド8a、8bは、アダプター8を容器本体10の内部に固定した際に、ガイド8a、8bの開口部上端が、容器本体10の開口部の縁よりも高く配置されるように形成したり、またはガイド8a、8bの開口部上端から容器本体の外側に向かい張り出すつば部を有してもよい。
なお、後述の検査方法2Bを実施するためには、第二室52から第一室51へ検体抽出液の流入を防止するため、複数の室のうち、少なくとも1室の底部には貫通孔を設けないことが好ましい。
アダプターの仕切板81の高さXは、容器本体10の検体抽出液収容部50の高さYを2とすると、2未満であり、1.8以下が好ましく、1.7以下がより好ましく、1.2~0.5が更により好ましい。
検査容器1B内に収容された検体抽出液に検体を溶出した後、検体抽出液をよく攪拌することで、検体の濃度が均等な検体抽出液が得られるが、容器本体10にアダプター8を挿入した後、各室毎の濃度勾配が生じることを防止するため、アダプターの仕切板81には、隣接する室と検体抽出液が連通可能に、連通穴を設けてもよい。
図8A、図8B、図9A、図9B、を用いて本発明について説明したが、本発明は上述の発明に限定されることはない。図10Aは実施形態に係る検査容器1の変形例の上面図、図10BはA-A断面図、図10CはB-B断面図である。
図8Aの検査容器では、第二室52から第一室51へ検体抽出液の流入を防止するため、第二室52の底部に貫通孔を設けない構成とした。しかし、検体抽出液の流入を防止する方法はこれに限定されることはない。例えば、図10Bに示すように、アダプター8は、上底状の底部を有する場合、アダプター8の底部8d、8fの容器本体側表面(第二面)の各室の境界線に対応する部分から、容器本体10の底部(第三面)に当接するように設けられた、各室間の溶液の流入を防止する流入防止板8gを有してもよい。
アダプター8は、底部に貫通孔を設けたがそれに限定されることなく、アダプター8の一部、例えば側壁等に貫通孔を設けてもよい。
アダプター8は、有底中空形状としたが、アダプター8の内部に仕切板が配置され、側壁により保持可能であれば、底を設けなくてもよい。
図11A、図11Bに示すように、容器本体10の検体抽出液収容部50が3室に区画されていてもよい。これにより、同一の検体抽出液を用いて、例えば、RSウィルス、アデノウィルス、ヒトメタニューモウィルスの検査を同時に行なうことができる。なお、後述の検査方法2Bを実施するためには、検体抽出液の流入を防止するため、図11Cに示すように、アダプター8の底部が容器本体の底部に密着するように、アダプター8の底部を構成してもよい。
また図12A、図12Bに示すように、容器本体10の検体抽出液収容部50が4室に区画されていてもよい。例えば、4種の検査を同時に行ったり、3種の検査をした後に感度が悪いものについて再検査することができる。また、検体抽出液収容部50が5室、6室、7室、・・・と多区画室となっていてもよい。
検査容器1B~3Bにおいては板状の仕切板を配置する構成としたが、検体抽出液収容部50が複数に区画されるのであればこれに限定されることはない。例えば、図13Aに示すように、中空円筒状の仕切板84をアダプター8の底部8dから凸設させる構成としてもよい。ここでは仕切板84の形状を、図13Bに示すように上面視円状の中空体としたがこれに限定されることなく、上面視三角、四角といった多角形状の中空体としてもよい。また仕切板84の内側に同心円状に、仕切板84と同様の形状をした中空状の仕切板をさらに配置して、検体抽出液収容部50を複数に区画してもよい。また仕切板84を更に2室以上に仕切る仕切板を配置して、検体抽出液収容部50を複数に区画してもよい。仕切板84の高さは検査容器1と同様の高さに構成してもよい。
実施形態に係る検査方法の工程について、図8A、図14A~図14F1を用いて説明する。
まず図8Aに示すような、有底中空形状をした可撓性の容器本体10を用意し、容器本体10内に検体抽出液を予め充填しておく。
使用時に、図14Aに示すように容器本体10のキャップを取り除き、その後図14Bに示すように、検体抽出液100が充填された容器本体10内に被検体を吸収した綿棒101を含漬させる。
その後、図14Dに示すように、容器本体10を外部からの圧力により変形させて、容器内壁に綿球を擦り付けるように綿棒101から被検体を絞り出す。
そして、図14Eに示すように、アダプター8を、容器本体10の内部に挿入する。検体抽出液がアダプター8の底部に設けられた貫通孔を介して、アダプター8内部に移行するように、アダプター8をゆっくり挿入することが好ましい。
図14F1に示すように、検査容器1Bの第一室51に第一試験片61、第二室52に第二試験片62を挿入する。
このように、検査方法1Bによれば、同一条件下に置かれた同一検体抽出液について、第一試験片61と第二試験片62により、それぞれ別項目の検査を略同時に行える。
以上より、容器本体10の内部に着脱自在に配置されるアダプター8の底部に仕切板を配置することがより好ましい。
上述の検査方法1Bにおいては、図14A~図14Eの工程の後、図14F1に示すように、第一試験片61と第二試験片62を、それぞれ第一室51、第二室52略同時に挿入した。しかし、図14F1の工程に換えて、図15F2に示すように、第一室51に第一試験片61を挿入してもよい。これにより、図15Gに示すように、第一室51内の検体抽出液が第一試験片61に吸収され尽くした後でも、図15Hに示すように、第二室52に第二試験片62を挿入することで、別項目の検査を行なうことができる。
なお、上げ底状の底部の全面に貫通孔を設けるときは、図10Bに示すように流入防止板8gを設けておくことが好ましい。その他にも、図11Cに示すように、アダプター8の底部が容器本体の底部に密着するように、アダプター8の底部を形成することが好ましい。
上記のように、本発明は実施形態によって記載したが、この開示の一部をなす論述及び図面はこの発明を限定するものであると理解すべきではない。この開示から当業者には様々な代替実施の形態、実施例及び運用技術が明らかとなろう。
このように、本発明はここでは記載していない様々な実施の形態等を含むことは勿論である。したがって、本発明の技術的範囲は上記の説明から妥当な特許請求の範囲に係る発明特定事項によってのみ定められるものである。
成形材料としてポリエチレンを用いて、射出成形により図8A、図8Bに示す検査容器1Bを調製した。その後、上述の検査方法1Bの手順に従って実験を行った。その際、被検体としてRSウィルス、アデノウィルス、ロタウィルス陽性検体を用い、第一試験片としてラピッドテスタ(登録商標)RSV-アデノ(積水メディカル社製)の試験片、第二試験片としてラピッドテスタ(登録商標)ロタ-アデノ(積水メディカル社製)の試験片を用いた。その結果、第一、第二試験片ともに、良好に検査を行なうことができた。
仕切板11がないことを除いて、図8A、図8Bと同様の構成を備える検査容器を調製し、実施例1Bと同様の実験を行なった。その結果、第一試験片と第二試験片とが交差し、第二試験片に流れ不良が生じた。
成形材料としてポリエチレンを用いて、射出成形により図8A、図8Bに示す検査容器1Bを調製した。その後、上述の検査2Bの手順に従って実験を行った。その際、被検体としてRSウィルス、アデノウィルス、ロタウィルス陽性検体を用い、第一試験片としてラピッドテスタ(登録商標)RSV-アデノ(積水メディカル社製)の試験片、第二試験片としてラピッドテスタ(登録商標)ロタ-アデノ(積水メディカル社製)の試験片を用いた。その結果、第一、第二試験片ともに、良好に検査を行なうことができた。
仕切板11がないことを除いて、図8A、図8Bと同様の構成を備える検査容器を調製し、実施例2Bと同様の実験を行なった。その結果、第一試験片が検体抽出液を吸収し尽くすために、第二試験片により別項目の検査を行えなかった。
8 アダプター
8a、8b ガイド
10 容器本体
11、21、31、41、81、82、83、84 仕切板
50 検体抽出液収容部
51 第一室
52 第二室
61、62 試験片
Claims (22)
- 有底中空形状をした可撓性の容器本体と、
前記容器本体の内側に軸方向に沿って形成された、前記容器本体の検体抽出液収容部を2以上の室に区画する仕切板と、を備える検査容器。 - 前記仕切板は、前記容器本体と一体に前記容器本体の底部から凸設している、請求項1に記載の検査容器。
- 前記容器本体の検体抽出液収容部は3以上の室に区画されている、請求項1又は2に記載の検査容器。
- 前記仕切板は、係止部により前記容器本体の内部に着脱自在に固定されている、請求項1~3のいずれか1項に記載の検査容器。
- 前記仕切板として、前記容器本体の底部から凸設した中空形状の仕切板を備える、請求項1~4のいずれか1項に記載の検査容器。
- 検体抽出液を収納した請求項1~5のいずれか1項に記載の検査容器と、試験片と、を備える検査キット。
- 容器の内側が軸方向に沿って2以上の室に区画された可撓性の検査容器内に収容された検体抽出液に、被検体を吸収した綿棒を含漬させる工程と、
前記検査容器を外部から圧力により変形させて、前記綿棒から被検体を絞り出す工程と、
前記検査容器の第一室に第一試験片を含漬させる第一含漬工程と、
を備える検査方法。 - 前記検査容器の第二室に第二試験片を含漬させる第二含漬工程をさらに備える、請求項7に記載の検査方法。
- 前記第二含漬工程は、前記第一含漬工程と略同時、または
前記第一含漬工程の後に行われる、請求項8に記載の検査方法。 - 有底中空形状をした可撓性の容器本体と、
前記容器本体の内部に着脱自在に固定された有底中空形状のアダプターと、を備え、
前記アダプターは、前記アダプターの底部から開口部側に向かい設けられた、前記アダプターの検体抽出液収容部を2以上の室に区画する仕切板を有する、検査容器。 - 前記アダプターは、その一部に貫通孔が形成されている、請求項10に記載の検査容器。
- 前記アダプターは、前記2以上の室の少なくとも1つの底部に貫通孔が形成されている、請求項10に記載の検査容器。
- 前記アダプターは、前記アダプターの内側における各室の境界線の延長線上に前記アダプターの開口部まで至るガイドを有する、請求項10~12のいずれか1項に記載の検査容器。
- 前記ガイドは、前記ガイドの開口部上端が、前記容器本体の開口部の縁よりも高く配置される、請求項13に記載の検査容器。
- 前記ガイドは、前記ガイドの開口部上端から、前記検査容器の外側に向かい張り出すつば部を有する、請求項14に記載の検査容器。
- 前記アダプターは、前記各室の境界線に対応する前記底部の前記容器本体側表面から前記容器本体の底部に当接するように設けられた、前記各室間の溶液の流入を防止する流入防止板をさらに有する、請求項10~15のいずれか1項に記載の検査容器。
- 前記アダプター本体の検体抽出液収容部は3以上の室に区画されている、請求項10~16のいずれか1項に記載の検査容器。
- 前記アダプターの外側半径は、前記容器本体の内法半径以上である、請求項10~17のいずれか1項に記載の検査容器。
- 検体抽出液を収納した請求項10~18のいずれか1項に記載の検査容器と、試験片と、を備える、検査キット。
- 有底中空形状をした可撓性の容器本体に収容された検体抽出液に、被検体を吸収した綿棒を含漬させる工程と、
前記容器本体を外部から圧力により変形させて、前記綿棒から被検体を絞り出す工程と、
有底中空形状のアダプター本体、前記アダプター本体の底部から開口部側に向かい設けられた前記アダプター本体の検体抽出液収容部を2以上の室に区画する仕切板を備え、前記2以上の室の少なくとも1つの底部に貫通孔が形成されたアダプターを前記容器本体の内部に挿入する工程と、
前記2以上の室のうちの第一室に第一試験片を含漬させる第一含漬工程と、を備える、検査方法。 - 前記2以上の室のうちの第二室に第二試験片を含漬させる第二含漬工程をさらに備える請求項20に記載の検査方法。
- 前記第二含漬工程は、前記第一含漬工程と略同時、または
前記第一含漬工程の後に行われる、請求項21に記載の検査方法。
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- 2017-03-13 CN CN201780015670.2A patent/CN108780029A/zh active Pending
- 2017-03-13 WO PCT/JP2017/009986 patent/WO2017159616A1/ja active Application Filing
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JP2019090754A (ja) * | 2017-11-16 | 2019-06-13 | 日本ケミコート化成株式会社 | 臨床検査用検体沈渣容器とこれを用いた検体沈渣方法 |
JP7012348B2 (ja) | 2017-11-16 | 2022-01-28 | 日本ケミコート化成株式会社 | 臨床検査用検体沈渣容器とこれを用いた検体沈渣方法 |
Also Published As
Publication number | Publication date |
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JP6867888B2 (ja) | 2021-05-12 |
EP3431953A1 (en) | 2019-01-23 |
EP3431953A4 (en) | 2019-09-25 |
KR20180121622A (ko) | 2018-11-07 |
CN108780029A (zh) | 2018-11-09 |
EP3431953B1 (en) | 2020-09-02 |
JP2018081074A (ja) | 2018-05-24 |
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