JP2010038797A - Container for specimen picking and inspection kit - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a container for specimen picking and an inspection kit being in no danger of specimen liquid leaking to the exterior in preparing the specimen liquid and used to appropriately introduce the specimen liquid in proper quantities into a detection kit. <P>SOLUTION: This container for specimen picking used to extract a specimen and introduce it into the inspection kit, comprises a container body and a lid part, and is equipped with opening parts at least in an upper end part and a lower end part, respectively, of the container body. This container has a structure in which the lid part is capable of sealing up the interior of the container body with a specimen picking tool closely put through the opening part in the upper end part while having a structure in which the opening part in the lower end part is sealed up. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a sample collection container and test kit used for measurement, examination, and diagnosis by mixing a sample with an extract, and in particular, a sample collected from the nose, throat, conjunctiva, etc. of a suspected patient as an extract. The present invention relates to a specimen collection container and a test kit for extraction, introduction into a test kit, and measurement / test / diagnosis.

As one of the methods for infectious disease inspection and health checkup, an inspection kit that can be easily and rapidly inspected has been used. Such a test kit generally uses an immunochromatography method, a flow-through method, an EIA method, or the like.
Samples used in the test kit are dispersed by immersing biological samples such as tears, eyelids, sputum, saliva, etc. of the suspected patient, gauze, cotton swabs, etc., in the sample processing container. Or it melt | dissolves and it prepares as a sample liquid. And it test | inspects by introduce | transducing the prepared sample liquid into a test | inspection kit etc.
For example, in a normal commercial product, a cotton swab from which a sample is collected is immersed in a tube containing the extract and stirred to prepare a sample solution. The infectious disease test is carried out by dripping in In this case, the sample liquid may be scattered when the sample is extracted from the cotton swab, and the cotton swab from which the sample is collected is left outside.
Moreover, in the method disclosed in Patent Document 1, the test is performed by directly dropping the sample liquid onto the test kit by attaching a lid with a nozzle for dropping the extract to the tip of the sample processing container. In this case, an appropriate amount of sample liquid cannot be introduced into the test kit, and detection or the like may be insufficient, or the sample liquid may overflow. In this case, the top and bottom of the sample collection container are turned over when the extract is dropped, so that the extract also touches the handle portion of the cotton swab.
In the method as described above, there is a risk of causing contamination with nosocomial infections and other diagnoses due to a cotton swab to which the sample is attached or a sample liquid spilled or scattered.
JP 2007-46959 A

  It is an object of the present invention to provide a sample collection container and a test kit that do not have a risk of leakage of the sample liquid to the outside at the time of preparation of the sample liquid and that can appropriately introduce an appropriate amount of the sample liquid into the detection kit. .

The present invention is as follows.
(1) A sample collection container for extracting a sample and introducing the sample into a test kit, comprising a container main body and a lid, and having openings at least at an upper end and a lower end of the container main body, The part has a structure in which the specimen collection instrument can be tightly penetrated through the opening at the upper end and the inside of the container body can be sealed, and the opening at the lower end is sealed. container.
(2) The specimen collection container according to (1), wherein the container main body has a structure in which the longitudinal and lateral lengths of the cross section of at least a part of the container body are different.
(3) The specimen collection container according to (2), which has a structure in which an internal cross-sectional shape of at least a part of the container body is an ellipse, an oval, or a rectangle.
(4) The specimen collection container according to any one of claims 1 to 3, wherein the opening at the lower end of the container body is sealed with a film or a removable cap.
(5) The specimen collection container according to any one of (1) to (4), in which an extract from which a specimen can be extracted is stored.
(6) The sample collection container according to any one of (1) to (5), wherein the sample collection device is a cotton swab.
(7) A test kit for testing a sample, the test kit having an introduction port for introducing a sample liquid containing the sample, wherein the sample collection container according to any one of (4) to (6) An inspection kit characterized by having a projection for making a hole in the film sealing the opening.
(8) The test kit according to (7), wherein immunochromatography is used as a test method.

The following effects can be obtained by using the sample collection container and the test kit of the present invention.
The lid for tightly penetrating a sample collection device such as a cotton swab of the sample collection container of the present invention seals the tip of the sample collection device to which the sample is attached and the sample liquid from which the sample has been extracted inside the sample collection container. Thus, an operation for preparing the sample liquid can be performed. Therefore, scattering of the sample liquid can be prevented, and the sample collection device to which the sample is attached does not have to be taken out.
Further, by adjusting the partial cross-sectional area of the sample collection container of the present invention, the change in the cross-sectional area due to the compression of the container when the sample liquid is introduced into the detection kit can be adjusted, so that the container is discharged from the container. The amount of the sample liquid can be adjusted to an appropriate amount for the measurement by the test kit. Therefore, overflow from the specimen liquid detection kit and lack of specimen liquid can be prevented.
Furthermore, since the sample liquid can be introduced into the detection kit through the opening at the lower end of the sample collection container of the present invention, and the container does not need to be turned upside down, the extract is brought into contact with the handle of the sample collection device. Can be prevented.
From the above, by using the present invention, it is possible to prevent nosocomial infection, contamination to other diagnoses, or contamination from other diagnoses.

Hereinafter, the best mode for carrying out the present invention will be described with reference to the drawings.
FIG. 1 is a schematic front view of a first example of the sample collection container of the present invention, FIG. 2 is a schematic side view of FIG. 1, FIG. 3 is a sectional view taken along the line I-II of FIG. -IV direction sectional drawing is shown.
1 to 4 includes a container main body 1 and a container lid 2, a filter 3 for removing solids from the sample liquid, and a seal 4 for sealing the inside of the container 1. The container body 1 is substantially cylindrical and has a circular cross-sectional shape. The container lid 2 is passed through the handle of the cotton swab 6, the sampled cotton swab 6 is inserted into the container body 1, and the tip of the cotton swab 6 attached to the sample and the extract are sealed inside the container body 1 with the container lid 2. can do. Therefore, the operation of extracting the specimen from the cotton swab 6 to the extract 5 can be performed in a state where the inside of the container body 1 is sealed. Then, the specimen liquid can be introduced into the detection kit by breaking the seal 4 and pressing the container body 1.

5 is a schematic front view of a second example of the sample collection container of the present invention, FIG. 6 is a schematic side view of FIG. 5, FIG. 7 is a sectional view taken along the line I-II of FIG. 5, and FIG. -IV direction sectional drawing is shown.
The second example of the sample collection container shown in FIGS. 5 to 8 includes a container body 7 and a container lid 2, a filter 3 for removing solids from the sample liquid, and a seal 4 for sealing the inside of the container 7. The upper half of the container body 7 is substantially cylindrical and has a circular cross-sectional shape, and the lower half has a cross-sectional shape that is oval. The container lid 2 is passed through the handle of the cotton swab 6, the sampled cotton swab 6 is inserted into the container body 7, and the tip of the cotton swab 6 attached to the sample and the extract are sealed inside the container body 7 with the container lid 2. can do. Therefore, an operation of extracting the specimen from the cotton swab 6 to the extract 5 can be performed in a state where the inside of the container body 7 is sealed. Then, by breaking the seal 4 and pressing the lower half of the container body 7 having an oval cross section from the short side direction, an appropriate amount of sample liquid can be introduced into the detection kit.

9 is a schematic front view of a third example of the sample collection container of the present invention, FIG. 10 is a schematic side view of FIG. 9, FIG. 11 is a cross-sectional view in the I-II direction of FIG. 9, and FIG. -IV direction sectional drawing is shown.
A third example of the sample collection container shown in FIGS. 9 to 12 includes a container body 8 and a container lid 2, a filter 3 that removes solids from the sample liquid, and a seal 4 that seals the inside of the container 7. The upper half of the container body 8 has a substantially cylindrical shape, and the cross-sectional shape is circular, and the cross-sectional shape of the lower half is rectangular. The container lid 2 is passed through the handle of the cotton swab 6, the sampled cotton swab 6 is inserted into the container body 8, and the tip of the cotton swab 6 attached to the sample and the extract are sealed inside the container body 8 with the container lid 2. can do. Therefore, the operation of extracting the specimen from the cotton swab 6 to the extract 5 can be performed in a state where the inside of the container body 8 is sealed. Then, by breaking the seal 4 and pressing the lower half of the container body 8 having a rectangular cross section from the short side direction, an appropriate amount of sample liquid can be introduced into the detection kit.

FIG. 13 is a schematic plan view of an example of a test kit corresponding to the first example of the sample collection container of the present invention, and FIG. 14 is a cross-sectional view in the I-II direction of FIG. Although FIGS. 13 to 19 show an example of a test kit using immunochromatography, the present invention can be used in other test systems, and the test method is not limited to this method.
In the test kit, the sample pad 15 for holding and passing the sample liquid, the sample and the first substance, and the binding substance of the sample and the first substance are chromatographed in the casing composed of the upper casing 9 and the lower casing 14. Membrane carrier 17, holding plate 18 for holding the membrane carrier, conjugate pad 16 containing a first substance (labeled with a labeling substance) that immunologically binds to the specimen, and absorption pad 19 for absorbing the developing solution Is stored. On the membrane carrier 17, there are a detection line 20 in which a second substance that specifically captures a specimen is held, and a control line 21 in which a third substance that traps the first substance is held. The upper casing 9 is provided with a circular inlet 10 for introducing the sample liquid into the sample pad 15, a protrusion 13 for breaking the seal 4 of the sample collection container, a determination window 11 and an air hole 12. 11, the detection line 20 and the control line 21 can be observed.

FIG. 15 is a schematic plan view of an example of a test kit corresponding to the second example of the sample collection container of the present invention, and FIG. 16 is a cross-sectional view taken along the line I-II of FIG.
In the test kit, the sample pad 15 for holding and passing the sample liquid, the sample and the first substance, and the binding substance of the sample and the first substance are chromatographed in the casing composed of the upper casing 9 and the lower casing 14. Membrane carrier 17, holding plate 18 for holding the membrane carrier, conjugate pad 16 containing a first substance (labeled with a labeling substance) that immunologically binds to the specimen, and absorption pad 19 for absorbing the developing solution Is stored. On the membrane carrier 17, there are a detection line 20 in which a second substance that specifically captures a specimen is held, and a control line 21 in which a third substance that traps the first substance is held. The upper casing 9 is provided with an oval inlet 22 for introducing the sample liquid into the sample pad 15, a projection 13 for breaking the seal 4 of the sample collection container, a determination window 11 and an air hole 12. The detection line 20 and the control line 21 can be observed from the window 11.

FIG. 17 is a schematic plan view of an example of a test kit corresponding to the third example of the sample collection container of the present invention, and FIG. 18 is a cross-sectional view taken along the line II-II of FIG.
In the test kit, the sample pad 15 for holding and passing the sample liquid, the sample and the first substance, and the binding substance of the sample and the first substance are chromatographed in the casing composed of the upper casing 9 and the lower casing 14. Membrane carrier 17, holding plate 18 for holding the membrane carrier, conjugate pad 16 containing a first substance (labeled with a labeling substance) that immunologically binds to the specimen, and absorption pad 19 for absorbing the developing solution Is stored. On the membrane carrier 17, there are a detection line 20 in which a second substance that specifically captures a specimen is held, and a control line 21 in which a third substance that traps the first substance is held. The upper casing 9 is provided with a rectangular inlet 23 for introducing the sample liquid into the sample pad 15, a protrusion 13 for breaking the seal 4 of the sample collection container, a determination window 11 and an air hole 12. 11, the detection line 20 and the control line 21 can be observed.

FIG. 19 shows a schematic cross-sectional view of a state in which the test kit of the present invention and the sample collection container are combined.
As shown in FIG. 19, when the lower end portion of the sample collection container is set in the introduction port of the test kit, the seal 4 is broken by the protrusion 13 provided in the introduction port, and the inside of the container 1 and the inside of the casing communicate with each other. The liquid can be introduced into the sample pad 15 in the casing. Then, the sample liquid can be introduced into the detection kit by pressing the container body 1.
In particular, in the second and third examples of the present invention, an appropriate amount of sample liquid is detected by pressing the lower half of the container body 7 or the container body 8 having an oval or rectangular cross section from the short diameter direction. Can be introduced into the kit.

  Although the embodiment of the present invention is not limited to the above-described example, a more detailed aspect will be described based on the examples of FIGS. 5 to 8 and FIGS.

  The base material of the container body 7 and the container lid 2 is preferably plastic in terms of ease of molding, cost, and lightness. Among plastics, a flexible material is more preferable because of the extrusion of the solution inside due to mechanical deformation and the sealing of the inside of the container due to the close contact of the container lid 2, the container body 7, and the cotton swab 6. Considering cost and biocompatibility in particular, polyethylene and polypropylene are more preferable. However, the present invention is not limited to these, and various plastic materials can be selected and used, processed, and used. According to the characteristics of the solvent, physiologically active substance, and detection method, it is appropriately selected in consideration of moldability, heat resistance, chemical resistance, adsorptivity, and the like. For example, polystyrene, polyvinyl chloride, polycarbonate, polyester, polymethyl methacrylate, polyvinyl acetate, vinyl-acetate copolymer, styrene-methyl methacrylate copolymer, acrylonitrile-styrene copolymer, acrylonitrile-butadiene-styrene copolymer. Examples thereof include a polymer, nylon, polymethylpentene, silicon resin, amino resin, polysulfone, polyethersulfone, polyetherimide, fluororesin, and polyimide. In addition, additives such as pigments, dyes, antioxidants, and flame retardants may be appropriately mixed with these plastic materials.

  It is not desirable for safety and health to take out and leave the jig from which the specimen is collected after the extraction work is completed, so it must be able to be stored in the extraction container, and the sample liquid may be scattered during the extraction work. For this reason, the container lid 2 that allows the cotton swabs to penetrate tightly so that the inside of the sample collection container can be sealed is required.

  The sample collection container body 7 has an opening through which the cotton swab 6 can be inserted and the container lid 2 can be attached at the upper end, and an opening through which the sample liquid inside the container can be taken out at the lower end. It is not necessary to invert the top and bottom of the container at the time of introduction into the container, and the contact of the extract with the handle of the swab 6 can be prevented. Moreover, in order to make it easy to insert a container lower end part into the inlet 22 of a casing, it is preferable to make it thin and a nozzle shape. However, the present invention is not limited to the above-described examples, and applications, modifications, and the like can be added within the scope of the invention with respect to the detailed structure and the like in accordance with the characteristics of the intended use, processing, and detection method.

When the container body 7 for sample collection has an oval cross section in the lower half, the cross-sectional area can be made smaller than a circle like the cross section in the upper half of the container 7, and the container is compressed Since the change in the cross-sectional area becomes small, the amount of liquid discharged can be adjusted. Therefore, by adjusting the shape of the cross section, the shape of the specimen collection container can be designed so that an appropriate amount of liquid is discharged. The same effect can be obtained even if the cross-sectional shape is a rectangle other than an oval or a circle having a different diameter. From this, the structure of the container body 7 or 8 is more preferable than the container body 1.
However, the shape of the sample collection container is not limited to the above example, and application, modification, and the like can be added to the detailed structure and the like within the scope of the invention.

  The filter 3 is attached to the opening at the lower end of the container body 1 and preferably has a hole diameter enough to trap a sample collected from a patient, a cotton swab, dust from gauze, etc., a sintered body or a nonwoven fabric using plastic or inorganic material, etc. Can be used. Further, it is more preferable that the filter 3 is hydrophobic so that the solution inside the container comes out only when the container is pressed. For ease of molding, a plastic sintered body is preferable, and polyethylene and polypropylene are more preferable from the viewpoint of cost and biocompatibility, but it is not limited thereto, and various plastic materials can be selected. It is appropriately selected in consideration of moldability, heat resistance, chemical resistance, adsorptivity, etc., according to the characteristics of the intended use, treatment, solvent used, physiologically active substance, and detection method. For example, polystyrene, polyvinyl chloride, polycarbonate, polyester, polymethyl methacrylate, polyvinyl acetate, vinyl-acetate copolymer, styrene-methyl methacrylate copolymer, acrylonitrile-styrene copolymer, acrylonitrile-butadiene-styrene copolymer. Examples thereof include a polymer, nylon, polymethylpentene, silicon resin, amino resin, polysulfone, polyethersulfone, polyetherimide, fluororesin, and polyimide. In addition, additives such as pigments, dyes, antioxidants, and flame retardants may be appropriately mixed with these plastic materials.

  The seal 4 is for closing the lower end opening part of the container body 1 so that the extraction liquid and the sample liquid inside the container body 1 do not leak to the outside. It can be closed with a cap or the like molded so that a thin film can be formed in the open part. Closure by a seal or a membrane is preferable due to cost and convenience of introduction of a sample liquid into a test kit, and it is also useful to use a cap to protect the seal portion. As a material for the seal, a plastic film or a metal foil can be used, and a film in which a plastic film or a metal foil is laminated may be suitable. The cap material is preferably plastic in terms of ease of molding, cost, and lightness, and polyethylene and polypropylene are more preferable in view of flexibility and cost.

  In general, a gauze, a fiber piece, a cotton swab or the like is used as the specimen collecting device. However, in the present invention, since it is held through the container lid 2, a rod-like one having a certain strength is preferable. A cotton swab is preferred.

Like the extract 5 in the figure, it is possible to save the trouble of dispensing the extract by taking the form of storing the extract in the sample collection container. Further, before the measurement, the extracted liquid in the sample collection container main body 7 can be separately stored in a sealed container when not in use so as not to deteriorate or spill out of the container. However, the extract is not limited to the above example.

  When introducing the sample liquid from the sample collection container of the present invention into the test kit, the seal 4 is peeled off or broken to make a hole. When the method of peeling off the seal 4 is performed, the method of breaking the seal 4 is preferable because there is a possibility of contact with the sample liquid that has come out of the opening. Furthermore, when the test kit of the present invention is used, the seal 4 is broken by the protrusion 12 when the lower end portion of the sample collection container is set in the introduction port 9, so that the opening of the sample collection container is not touched. In addition, the sample liquid can be introduced without spilling the sample liquid to the outside.

  Although the test kit of the present invention is not limited to the examples of FIGS. 13 to 19, a system using immunochromatography will be described in particular.

  The base material of the upper casing 9 and the lower casing 14 is preferably plastic in terms of ease of molding, cost, and lightness. Various plastic materials can be selected as the plastic material. Formability, heat resistance, and chemical resistance are selected according to the characteristics of the intended use, treatment, solvent used, bioactive substance, and detection method. In consideration of the adsorptivity and the like, it is appropriately selected. For example, polystyrene, polyethylene, polyvinyl chloride, polypropylene, polycarbonate, polyester, polymethyl methacrylate, polyvinyl acetate, vinyl-acetate copolymer, styrene-methyl methacrylate copolymer, acrylonitrile-styrene copolymer, acrylonitrile- Examples include butadiene-styrene copolymer, nylon, polymethylpentene, silicone resin, amino resin, polysulfone, polyethersulfone, polyetherimide, fluororesin, and polyimide. In addition, additives such as pigments, dyes, antioxidants, and flame retardants may be appropriately mixed with these plastic materials.

  In the upper casing 9 and the lower casing 14, structures for fixing the contents such as the sample pad 15, the holding plate 18, the conjugate pad 16, the membrane carrier 17, and the absorption pad 19 can be appropriately formed.

  The determination window 11 through which the detection line 20 and the control line 21 can be observed from the inspection kit of the present invention is a through hole through which the upper casing 9 is penetrated, but it is only necessary to observe the detection line 20 and the control line 21 inside the casing. It can also be used as a judgment window by using a transparent plastic plate or film. If there is an air hole, the absorption of the specimen liquid by the absorption pad 19 may be good. Therefore, the upper casing 9 preferably has an air hole 12 that is a processed through hole.

  Sample pad 15 for holding and passing the specimen liquid, holding plate 18 for holding the membrane carrier 17, conjugate pad 16 containing a first substance (labeled with a labeling substance) that immunologically binds to the specimen, and specimen And a membrane carrier 17 for chromatographic development of the first substance and the binding substance of the specimen and the first substance, an absorption pad 19 for absorbing the developing liquid, and a detection in which the second substance for specifically capturing the specimen is retained. The strip which consists of the line 20 and the control line 21 in which the 3rd substance which capture | acquires a 1st substance is hold | maintained can use the strip for immunochromatography generally used. It is designed appropriately according to the type, concentration, required measurement sensitivity, type of extract, cost, etc. to be measured.

  As the membrane carrier 17, nitrocellulose having a pore size of 0.1 to 3 μm, glass fiber, polyethersulfone (PES), cellulose, nylon and the like are used, and among these, nitrocellulose is generally used. However, it is not limited to this. As the conjugate pad 16, glass fiber, cellulose cloth (filter paper, nitrocellulose membrane, etc.), porous plastic cloth such as polyethylene, polypropylene, etc. are used. Of these, glass fiber is generally used. It is not limited to this.

  Examples of the labeling substance include metal colloids such as gold colloid and platinum colloid, synthetic latex such as polystyrene latex colored with respective pigments such as red and blue, and latex such as natural rubber latex. Metal colloids such as gold colloids are commonly used but are not particularly limited. As the first substance held in the conjugate pad 16, a substance that specifically reacts with the specimen is selected, and examples thereof include, but are not limited to, antigens, antibodies, aptamers, peptides, and lectins. As the second substance held in the detection line 20, a substance that specifically reacts with the sample is selected, and examples thereof include, but are not limited to, antigens, antibodies, aptamers, peptides, and lectins. As the third substance retained in the control line 21, a substance that reacts with at least the first substance is selected, and examples thereof include, but are not limited to, antigens, antibodies, aptamers, peptides, and lectins.

  Since the present invention has a structure that prevents scattering and leakage of the specimen, it is more effective when the specimen contains infectious pathogens. Infectious pathogens include influenza virus, adenovirus, hepatitis B virus, type A streptococcus, chlamydia, and the like.

  The present invention is not limited to the examples described above, and applications, modifications, and the like can be added to the detailed structure and the like within the scope of the invention.

Example 1
The specimen collection container described in FIGS. The container body 1 and the container lid 2 were produced by injection molding using polyethylene as a material. The dimensions of the container body 1 were a cylindrical shape with a length of 70 mm and a diameter of 12 mm, and the nozzle-shaped part with a thin lower end was a diameter of 4 mm and a length of 4 mm, and a through hole with a diameter of 3.5 mm was provided. The container lid 2 had a diameter of 12 mm, a height of 7 mm, and a hole penetrating the handle of the cotton swab at the center of 2 mm in diameter. As the filter 3, a polyethylene sintered filter was liquid-tightly fitted into the lower end opening of the container body 1. The seal 4 was sealed by bonding an aluminum seal to the lower end opening of the container body 1.

  The test kit described in FIGS. 13 to 14 was prepared. The upper casing 9 and the lower casing 14 were produced by injection molding using a white-colored polycarbonate (PC) material. The dimensions are 20 mm in length, 80 mm in width, and 15 mm in height. The circular introduction port 10 has a through-hole with a diameter of 4 mm, and the lower end of the container body 1 fits around it, and the seal 4 is placed at the center of the through-hole. Protrusion 13 for breaking came. The protrusion 13 was conical with a diameter of 1 mm and a height of 2 mm. The dimensions of the judgment window 11 were 4 mm in length and 20 mm in width, and the dimensions of the air hole 12 were 4 mm in length and 1 mm in width, with three holes.

For the production of the strip, a cellulose sample pad (Millipore, C083 type) is used as the sample pad 15, a glass fiber conjugate pad (Millipore, G041 type) is used as the pad for the conjugate pad 16, and a high flow plus (Millipore, Millipore, HF180) was used as the absorbent pad 19 and a cellulose absorbent pad (Millipore, C083 type). Monoclonal mouse anti-human serum albumin (manufactured by Hytest, 4T24, 1A9) labeled with colloidal gold is used as the first substance that immunologically binds to the specimen, and Monoclonal mouse anti- Human serum albumin (Hytest 4T24, 15C7) and Rabbit Anti-Mouse Immunoglobulins (DAKO, Z0109) were used as the third substance to capture the first substance.
A conjugate pad was prepared by immersing the first substance in a glass fiber conjugate pad and vacuum drying. A second substance is fixed to the membrane carrier as the detection line 20 and a third substance is fixed as the control line 21, combined with the sample pad, conjugate pad, and absorption pad, cut, and 60 mm long and 5 mm wide. Strips were made.
The strip was installed in the lower casing 14, and the upper casing 9 was joined by fitting the upper casing and the lower casing to obtain an inspection kit.

  PURIFIED HUMAN ALBUMIN (manufactured by MP BIOMEDICALS, 55912) was used as an analyte to be a specimen, and PBS buffer containing 0.05% Triton X100 was used as an extract. The container lid 2 is penetrated through the handle of the cotton swab 6 to attach the specimen, and the tip of the cotton swab to which the specimen is attached is inserted into the container 1 in which 500 μL of the extract is placed, and the inside of the container is sealed with the container lid 2. did. The tip of the cotton swab to which the specimen was attached was immersed in the extract 5 inside the container 1, rubbed against the wall of the container, squeezed, and stirred to dissolve the specimen in the extract.

  The lower end of the sample collection container 1 was inserted into the circular inlet 10 of the test kit, and the seal 4 was broken by the protrusion 13. Then, the lower end portion of the container 1 was pulled out from the introduction port, and the container 1 was pressed while confirming the liquid droplets coming out from the lower end portion, and 3 drops corresponding to 100 μL of the sample liquid were introduced into the sample pad 15. After 15 minutes, the coloring of the detection line 20 and the control line 21 was confirmed from the determination window 11. By using the sample collection container and the test kit, it was possible to measure the sample without the sample liquid leaking from the apparatus at each stage of operation.

(Example 2)
The specimen collection container described in FIGS. The container body 7 and the container lid 2 were produced by injection molding using polyethylene as a material. The dimensions of the container body 7 are as follows: the upper half 40 mm is a cylindrical shape with a diameter of 12 mm, and the lower half 30 mm has a cross-sectional shape with different lengths in the vertical and horizontal directions, a vertical length of 12 mm and a horizontal length. The nozzle-shaped part with a lower end of 4 mm in diameter and 4 mm in length was provided with a through hole having a diameter of 3.5 mm. The container lid 2 had a diameter of 12 mm, a height of 7 mm, and a hole penetrating the handle of the cotton swab at the center of 2 mm in diameter. As the filter 3, a polyethylene sintered filter was liquid-tightly fitted into the lower end opening of the container body 7. The seal 4 was sealed by bonding an aluminum seal to the lower end opening of the container body 1.

  The test kit described in FIGS. 15 to 16 was prepared. The upper casing 9 and the lower casing 14 were produced by injection molding using a white-colored acrylic (PMMA) material. The length is 20 mm, the width is 80 mm, and the height is 15 mm. The oval inlet 22 has a through-hole with a diameter of 4 mm, and the lower end of the container body 7 fits around it. Protrusion 13 to break is now coming. The protrusion 13 was conical with a diameter of 1 mm and a height of 2 mm. The dimensions of the judgment window 11 were 4 mm in length and 20 mm in width, and the dimensions of the air hole 12 were 4 mm in length and 1 mm in width, with three holes.

For the production of the strip, a cellulose sample pad (Millipore, C083 type) is used as the sample pad 15, a glass fiber conjugate pad (Millipore, G041 type) is used as the pad for the conjugate pad 16, and a high flow plus (Millipore, Millipore, HF180) was used as the absorbent pad 19 and a cellulose absorbent pad (Millipore, C083 type). Monoclonal mouse anti-human serum albumin (manufactured by Hytest, 4T24, 1A9) labeled with colloidal gold is used as the first substance that immunologically binds to the specimen, and Monoclonal mouse anti- Human serum albumin (Hytest 4T24, 15C7) and Rabbit Anti-Mouse Immunoglobulins (DAKO, Z0109) were used as the third substance to capture the first substance.
A conjugate pad was prepared by immersing the first substance in a glass fiber conjugate pad and vacuum drying. A second substance is fixed to the membrane carrier 17 as the detection line 20, and a third substance is fixed as the control line 21, combined with the sample pad, the conjugate pad, and the absorption pad, cut, and has a length of 60 mm, a width A 5 mm strip was made.
The strip was installed in the lower casing 14, and the upper casing 9 was joined by fitting the upper casing and the lower casing to obtain an inspection kit.

  PURIFIED HUMAN ALBUMIN (manufactured by MP BIOMEDICALS, 55912) was used as an analyte to be a specimen, and PBS buffer containing 0.05% Triton X100 was used as an extract. The container lid 2 is passed through the handle of the cotton swab 6, the specimen is attached, the tip of the cotton swab to which the specimen is attached is inserted into the container 7 in which 500 μL of the extract is placed, and the inside of the container is sealed with the container lid 2. did. The tip of the cotton swab to which the sample was attached was immersed in the extract 5 inside the container 7 and rubbed or squeezed against the wall surface of the container and stirred to dissolve the sample in the extract.

  The lower end of the sample collection container 7 was inserted into the oval inlet 22 of the test kit, and the seal 4 was broken by the protrusion 13. Then, the wall surface facing the lower half of the container 7 was pressed with a finger until the wall surface touched the cotton swab 6, and about 100 μL was introduced into the sample pad 15. After 15 minutes, the coloring of the detection line 20 and the control line 21 was confirmed from the determination window 11. By using the sample collection container and the test kit, it was possible to measure the sample without the sample liquid leaking from the apparatus at each stage of operation.

(Example 3)
Sample collection containers described in FIGS. 9 to 12 were prepared. The container body 8 and the container lid 2 were produced by injection molding using polypropylene as a material. The dimensions of the container body 8 are: a cylindrical shape with a diameter of 12 mm in the upper half 40 mm, a rectangular cross section of the lower half 30 mm with a long side of 12 mm and a short side of 6 mm. A through hole having a diameter of 3.5 mm was provided. The container lid 2 had a diameter of 12 mm, a height of 7 mm, and a hole penetrating the handle of the cotton swab at the center of 2 mm in diameter. As the filter 3, a polyethylene sintered filter was liquid-tightly fitted into the lower end opening of the container body 8. The seal 4 was sealed by bonding an aluminum seal to the lower end opening of the container body 8.

  The test kit described in FIGS. The upper casing 9 and the lower casing 14 were produced by injection molding using a white-colored polystyrene (PS) material. The dimensions are 20 mm in length, 80 mm in width, and 15 mm in height. The rectangular introduction port 23 has a through-hole with a diameter of 4 mm, and the lower end of the container body 8 fits around it, and the seal 4 is placed at the center of the through-hole. Protrusion 13 for breaking came. The protrusion 13 was conical with a diameter of 1 mm and a height of 2 mm. The dimensions of the judgment window 11 were 4 mm in length and 20 mm in width, and the dimensions of the air hole 12 were 4 mm in length and 1 mm in width, with three holes.

For the production of the strip, a cellulose sample pad (Millipore, C083 type) is used as the sample pad 15, a glass fiber conjugate pad (Millipore, G041 type) is used as the pad for the conjugate pad 16, and a high flow plus (Millipore, Millipore, HF180) was used as the absorbent pad 19 and a cellulose absorbent pad (Millipore, C083 type). Monoclonal mouse anti-human serum albumin (manufactured by Hytest, 4T24, 1A9) labeled with colloidal gold is used as the first substance that immunologically binds to the specimen, and Monoclonal mouse anti- Human serum albumin (Hytest 4T24, 15C7) and Rabbit Anti-Mouse Immunoglobulins (DAKO, Z0109) were used as the third substance to capture the first substance.
A conjugate pad was prepared by immersing the first substance in a glass fiber conjugate pad and vacuum drying. A second substance is fixed to the membrane carrier 17 as the detection line 20, and a third substance is fixed as the control line 21, combined with the sample pad, the conjugate pad, and the absorption pad, cut, and has a length of 60 mm, a width A 5 mm strip was made.
The strip was installed in the lower casing 14, and the upper casing 9 was joined by fitting the upper casing and the lower casing to obtain an inspection kit.

  PURIFIED HUMAN ALBUMIN (manufactured by MP BIOMEDICALS, 55912) was used as an analyte to be a specimen, and PBS buffer containing 0.05% Triton X100 was used as an extract. The container lid 2 is passed through the handle of the cotton swab 6 to attach the specimen, and the tip of the cotton swab to which the specimen is attached is inserted into the container 8 in which 500 μL of the extract is placed, and the inside of the container is sealed with the container lid 2. did. The tip of the cotton swab to which the specimen was attached was immersed in the extract 5 inside the container 8, rubbed against the wall surface of the container, stirred, and stirred to dissolve the specimen in the extract.

  The lower end of the specimen collection container 8 was inserted into the rectangular inlet 23 of the test kit, and the seal 4 was broken by the protrusion 13. Then, the lower half of the container 8 was pressed with fingers to the extent that the opposing wall faces touched, and about 100 μL was introduced into the sample pad 15. After 15 minutes, the coloring of the detection line 20 and the control line 21 was confirmed from the determination window 11. By using the sample collection container and the test kit, it was possible to measure the sample without the sample liquid leaking from the apparatus at each stage of operation.

  The present invention relates to a sample collection container and a test kit used for measurement, inspection, and diagnosis by mixing a sample with an extract, and in particular extracts a sample collected from the nose, throat, conjunctiva, stool, etc. of a suspected patient It can be extracted into a liquid, introduced into a test kit, and applied to a sample collection container and a test kit for measurement, inspection, and diagnosis.

The outline front view of the 1st example of the sample collection container of the present invention. The outline | summary side view of FIG. I-II direction sectional drawing of FIG. III-IV direction sectional drawing of FIG. The outline front view of the 2nd example of the sample collection container of the present invention. FIG. 6 is a schematic side view of FIG. 5. I-II sectional view of FIG. III-IV sectional view of FIG. The outline front view of the 3rd example of the sample collection container of the present invention. FIG. 10 is a schematic side view of FIG. 9. I-II sectional view of FIG. Sectional view in the III-IV direction of FIG. FIG. 3 is a schematic plan view of an example of a test kit corresponding to the first example of the specimen collection container of the present invention. I-II direction sectional view of FIG. The plane schematic diagram of the example of the test | inspection kit corresponding to the 2nd example of the sample collection container of this invention. 15 is a cross-sectional view in the I-II direction of FIG. The schematic plan view of the example of the test | inspection kit corresponding to the 3rd example of the sample collection container of this invention. FIG. 17 is a sectional view taken along the line I-II. Schematic cross-sectional view of a combination of the test kit of the present invention and a sample collection container

Explanation of symbols

1 …… Sample body for specimen collection (circular cross section)
2 ... Container lid 3 ... Filter 4 ... Seal 5 ... Extract 6 ... Cotton swab 7 ... Sample collection container body (lower half section is oval)
8 …… Sample body for sample collection (cross section of lower half is rectangular)
9 ... Upper casing 10 ... Circular inlet 11 ... Judgment window 12 ... Air hole 13 ... Projection for breaking the seal 14 14 ... Lower casing 15 ... Sample pad 16 ... Conjugate pad 17 ... ... Membrane carrier 18 ... Holding plate 19 ... Absorption pad 20 ... Detection line 21 ... Control line 22 ... Elliptical inlet 23 ... Rectangular inlet

Claims (8)

  A sample collection container for extracting a sample and introducing it into a test kit, comprising a container main body and a lid part, comprising at least an upper end part and a lower end part of the container main body, wherein the lid part is A specimen collection container having a structure in which a specimen collection instrument can be tightly penetrated through an opening at an upper end to seal the inside of the container body, and the opening at the lower end is sealed.   The specimen collection container according to claim 1, wherein the container main body has a structure in which a length in a longitudinal direction and a lateral direction of at least a part of the container body are different.   The sample collection container according to claim 2, wherein a cross-sectional shape inside at least a part of the container body is an ellipse, an oval, or a rectangle.   The specimen collection container according to any one of claims 1 to 3, wherein the opening at the lower end of the container body is sealed with a film or a removable cap.   The sample collection container according to any one of claims 1 to 4, wherein an extract from which a sample can be extracted is stored.   The sample collection container according to claim 1, wherein the sample collection device is a cotton swab.   A test kit for testing a sample, comprising an inlet for introducing a sample liquid containing the sample, wherein the opening of the sample collection container according to any one of claims 4 to 6 is sealed in the inlet. Inspection kit characterized by having protrusions that make holes in the film.   The test kit according to claim 7, wherein immunochromatography is used as a test method.

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