WO2016031899A1 - Nozzle cap for specimen test container, and specimen test container and specimen test kit using same - Google Patents

Nozzle cap for specimen test container, and specimen test container and specimen test kit using same Download PDF

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Publication number
WO2016031899A1
WO2016031899A1 PCT/JP2015/074170 JP2015074170W WO2016031899A1 WO 2016031899 A1 WO2016031899 A1 WO 2016031899A1 JP 2015074170 W JP2015074170 W JP 2015074170W WO 2016031899 A1 WO2016031899 A1 WO 2016031899A1
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WO
WIPO (PCT)
Prior art keywords
filter
container
nozzle
sample
specimen test
Prior art date
Application number
PCT/JP2015/074170
Other languages
French (fr)
Japanese (ja)
Inventor
中村　公一
耕一 角脇
英樹 菊入
Original Assignee
アルフレッサファーマ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by アルフレッサファーマ株式会社 filed Critical アルフレッサファーマ株式会社
Priority to JP2016545603A priority Critical patent/JPWO2016031899A1/en
Priority to KR1020177008240A priority patent/KR102481556B1/en
Publication of WO2016031899A1 publication Critical patent/WO2016031899A1/en

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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
    • 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
    • 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

Definitions

  • the present invention relates to a nozzle cap for a specimen test container, and a specimen test container and a specimen test kit using the same.
  • a part of secretions such as wiping liquid and nasal discharge or excrement such as urine and stool collected from a patient's pharynx and nasal cavity using a sampling tool is used as a specimen test container.
  • Prepare a sample solution by suspending in a buffer solution.
  • the assay is performed by dropping the specimen sample solution in the specimen test container onto a predetermined position of the test plate included in the kit.
  • the specimen sample solution is used. Is filtered by a filter in the specimen sample container. The performance of this filtration greatly affects the performance of the assay.
  • FIG. 9 is a diagram schematically showing an example of a sample test container included in a conventional sample test kit.
  • the conventional specimen test container 900 includes a container base 920 for containing the specimen sample liquid, and a nozzle cap 940 for filtering the specimen sample liquid and discharging it from the dropping port 942.
  • the container base 920 includes a connection portion 924 that is open and has a thread on the outer surface.
  • the connecting portion 924 is set in a shape that can be screwed with a screw thread (not shown) provided on the inner surface of the cap 944 below the nozzle cap 940.
  • Both the container base 920 and the nozzle cap 940 are formed of a thermoplastic resin such as polypropylene.
  • FIG. 10 is a diagram schematically showing a nozzle cap 940 constituting the conventional specimen test container 900 shown in FIG. 9, wherein (a) is a longitudinal sectional view of the nozzle cap 940, and (b) ) Is an exploded longitudinal sectional view of the nozzle cap 940.
  • the nozzle cap 940 includes a nozzle body 941 having a nozzle tube 943 communicating with the dropping port 942 and a cap portion 944.
  • the lower end of the nozzle body 941 is formed integrally with the cap portion 944, and the base end portion 948 of the cap portion 944 provided in a direction substantially perpendicular to the axial direction of the nozzle body 941 is within the cap portion 944.
  • a filter 950 is fitted in a cylindrical filter housing portion 946 extending in a direction substantially perpendicular to the base end portion 948.
  • the filter housing portion 946 is also fitted or screwed with an internal cap 960 from the outside, and the filter housing portion 946 and the inner wall 964 of the internal cap 960 are fixed.
  • the lower end of the inner cap 960 is provided with a filter hole 962 designed to be somewhat smaller than the outer diameter of the filter 950.
  • the filter 950 is sandwiched and fixed by the base end portion 948 in the nozzle cap 940, the filter housing portion 946, and the inner cap 960.
  • the nozzle cap 940 alone needs to be configured by at least three members.
  • the outer periphery of the filter 950 is configured to be locked by the internal cap 960 of the locking member, the sample liquid is filtered at the time of use due to the internal cap 960 and / or the filter 950 being dropped or the filter 950 being displaced. The risk of being used for measurement without having to be used is to be avoided.
  • An object of the present invention is to solve the above-mentioned problems.
  • the object of the present invention is to eliminate the inconvenience in manufacturing and to remove a specimen sample at the time of use due to dropping of a locking member or a filter or displacement of a filter.
  • the object is to provide a nozzle cap for a specimen test container, and a specimen test container and a specimen test kit using the same, which are free from the risk of being used for measurement without being filtered.
  • the present invention is a nozzle cap that can be connected to the open end of the container base to constitute a specimen test container,
  • a nozzle body comprising a cap portion connectable to the open end of the container base and a nozzle tube for discharging the sample liquid from the dropping port; and a filter accommodated in the nozzle body;
  • the nozzle body has a cylindrical filter housing portion inside the cap portion, and the filter is housed in the filter housing portion by folding a plurality of lips provided at the open end of the filter housing portion. And a nozzle cap that is locked.
  • the plurality of lips are provided at substantially equal intervals on the open end of the filter housing portion.
  • the number of the plurality of lips is 2 to 16.
  • the nozzle body is made of a thermoplastic resin.
  • locking of the filter by folding the plurality of lips is performed by ultrasonic treatment.
  • the present invention is also a container for storing a sample liquid for performing a sample test, the container including the nozzle cap; and a container base for storing the sample liquid.
  • the present invention also includes a container for storing the specimen sample solution, A test plate for assaying the characteristics of an object to be measured contained in the sample liquid; Is a sample test kit.
  • the sample test kit of the present invention further includes a collection tool for collecting a sample.
  • the manufacturing complexity can be eliminated, and the manufacturing cost can be reduced.
  • the specimen sample liquid is released from the risk of being used for measurement without being filtered by use of the locking member or the filter, or the displacement of the filter. In this case, it is possible to avoid that unnecessary substances in the sample liquid are accidentally dropped on the test plate of the sample sample kit. As a result, the object to be measured can be detected with higher accuracy in a short time.
  • FIG. 1 It is a figure for demonstrating an example of the nozzle cap of this invention, Comprising: It is a schematic cross section of the said cap. It is a bottom view of the nozzle cap of this invention shown in FIG. It is a figure which represents typically the nozzle cap which comprises the sample test container of this invention, Comprising: It is sectional drawing of the said nozzle cap and filter for demonstrating the state before attaching a filter. It is a model bottom view of the nozzle cap before attaching the filter shown in FIG. It is a figure which represents typically some examples of the shape of the lip
  • FIG. 10 is a diagram schematically illustrating a nozzle cap constituting the conventional specimen test container shown in FIG. 9, wherein (a) is a longitudinal sectional view of the nozzle cap, and (b) is an exploded longitudinal view of the nozzle cap.
  • the specimen test container nozzle cap of the present invention (hereinafter referred to as “nozzle cap”) can be connected to the open end of the container base to constitute a specimen test container.
  • the term “specimen test container” used in this specification refers to a container for containing various specimen sample liquids for performing a specimen test.
  • FIG. 1 is a view for explaining an example of a nozzle cap of the present invention, and is a schematic cross-sectional view of the cap.
  • the nozzle cap 140 of the present invention includes a nozzle body 141 and a filter 150. Further, the nozzle body 141 is composed of a nozzle tube 143 and a cap portion 144. In the present invention, it is preferable that the nozzle tube 143 and the cap portion 144 are integrally formed for the purpose of eliminating the complexity of the manufacturing process.
  • the nozzle tube 143 has a dripping port 142 for discharging (for example, dripping) the filtered sample liquid.
  • the nozzle tube 143 has, for example, a tapered shape so as to increase in diameter from the upper side to the lower side of the drawing. The lower end of the nozzle tube 143 may be in contact with the filter 150 or may be arranged with a predetermined gap.
  • the shape of the dripping port 142 is not necessarily limited, but is, for example, circular, and the outer diameter is preferably 1 mm to 5 mm, more preferably 2 mm to 4 mm.
  • the length of the nozzle tube 143 is preferably 8 mm to 20 mm, more preferably 10 mm to 15 mm.
  • a cylindrical filter housing portion 146 is provided that extends along the axial direction of the nozzle tube 143 (for example, substantially parallel to the axial direction of the nozzle tube 143).
  • the filter accommodating portion 146 preferably has a cylindrical shape.
  • the dropping port 142, the nozzle tube 143, and the filter housing portion 146 communicate with each other, and the sample liquid in the sample test container can be discharged from the filter housing portion 146 to the dropping port 142 through the nozzle tube 143.
  • the filter housing portion 146 houses the filter 150 therein. It is preferable that the inner diameter of the filter housing portion 146 is designed to match the outer diameter of the filter to be used, or to be slightly smaller than the outer diameter of the filter.
  • the inner diameter of the filter accommodating portion 146 is, for example, 2 mm to 15 mm, preferably 4 mm to 12 mm.
  • the filter housing portion 146 is also preferably designed so as to be slightly reduced in diameter toward the top of the drawing (that is, the side where the nozzle tube 143 is provided). This is to further improve the adhesion between the accommodated filter 150 and the inner wall of the filter accommodating portion 146.
  • the filter 150 is housed and locked in the filter housing portion 146 by folding a plurality of lips 149 provided at the open end 147 of the filter housing portion 146. That is, in one embodiment of the present invention, the plurality of lips 149 are formed integrally with the filter housing portion 146 on the open end 147 side of the filter housing portion 146, and the end portion of the lip 149 is the filter housing portion 146.
  • the filter 150 is housed and locked in the filter housing portion 146 by a plurality of lips 149.
  • the term “folding of a plurality of lips” used in the present specification means that a plurality of lips formed integrally with the filter housing portion are formed in the direction of the central axis of the filter housing portion 146 as shown in FIG.
  • the filter 150 includes a filter housing portion 146, a plurality of lips 149, and a base end of the cap portion 144 corresponding to the other end (the end opposite to the dripping port 142) of the nozzle pipe 143 of the nozzle body 141. It is preferable that the filter 150 is fixed between the filter 150 and the filter accommodating portion 146, the plurality of lips 149, and the base end portion 148 so that no gap is formed between them. More preferably, they are in contact with each other.
  • FIG. 2 is a bottom view of the nozzle cap of the present invention shown in FIG.
  • the plurality of lips 149 are preferably provided at substantially equal intervals on the open end 147 of the filter housing portion 146.
  • the periphery of the filter 150 is more evenly formed by folding the filter lip 149 toward the center of the filter housing portion 146 in a state where the lips 149 are arranged around the filter 150 at substantially equal intervals.
  • the stability of the filter 150 in the filter housing part 146 can be increased.
  • the number of lips 149 provided in one nozzle cap 140 is not necessarily limited as long as it does not overlap and interfere with each other by folding, but is preferably 2 to 16.
  • the filter 150 may not be properly locked, and the stability of the filter 150 in the filter housing portion 146 may not be maintained. If the number of lips 149 exceeds 16, adjacent lips overlap and interfere with each other, resulting in not only preventing the filter 150 from being locked, but also surrounding the filter 150 with more lips 149. Become. As the filtration area of the filter 150 decreases, the filtration efficiency may decrease.
  • the nozzle cap 140 of the present invention is preferably made of, for example, a transparent material so that the presence or absence of the sample liquid sample can be visually recognized from the outside. Further, the nozzle cap 140 is preferably made of a plastic material such as a thermoplastic resin.
  • thermoplastic resins include, but are not necessarily limited to, polypropylene, polyethylene, polyvinyl chloride, polyethylene terephthalate, polystyrene and the like. From the viewpoint of excellent chemical resistance and versatility, polyethylene or polypropylene is preferable.
  • the nozzle cap 140 can be molded by, for example, injection molding by using the thermoplastic resin as described above, and the filter 150 can be fixed by a plurality of lips 149, for example, as described later. It can be achieved by sonication.
  • the material of the filter 150 accommodated in the nozzle cap 140 is not particularly limited, and a filter material employed in a specimen test container included in a conventional test kit can be used.
  • the filter material is a material that can be used for microfiltration, for example.
  • filter materials are cellulose, glass fiber, silica fiber, nitrocellulose, cellulose ester, polyethersulfone, polysulfone, tetrafluoroethylene resin, vinylidene fluoride resin, polycarbonate, polypropylene, polyamide, nylon 6,6, polyester , Cotton, and stainless steel fibers, and combinations thereof.
  • the thickness of the filter 150 is not particularly limited, and any thickness can be selected by those skilled in the art.
  • FIG. 3 is a diagram schematically showing a nozzle cap constituting the specimen test container of the present invention, and is a sectional view of the nozzle cap and the filter for explaining a state before the filter is attached.
  • the nozzle cap 240 before the filter is attached has a dripping port 242, a nozzle tube 243, and a filter housing portion 246 formed in advance by injection molding.
  • the lip 249 is provided on the open end 247 of the filter housing portion 246 along the axial direction of the nozzle tube 243 (that is, in a direction substantially parallel to the axial direction of the nozzle tube 243).
  • the open end 247 of the filter housing portion 246 preferably has a plane that is substantially perpendicular to the lip 249 (that is, a direction perpendicular to the axial direction of the nozzle tube 243).
  • FIG. 4 is a schematic bottom view of the nozzle cap 240 shown in FIG.
  • the base end portion 248 has, for example, a substantially flat plane in a direction perpendicular to the axial direction of the nozzle tube 243, and is in close contact with the filter to be accommodated so that the filter is further layered in the filter accommodating portion. Can be fixed properly. Further, the base end portion 248 is provided with a plurality of grooves 252 from the periphery of the filter housing portion 246 toward the end portion of the central nozzle tube 243. The specimen test solution filtered from the container base through the filter is collected in the nozzle tube 243 through the grooves 252 and discharged from the dropping port 242 to the outside.
  • a portion corresponding to the base end portion 248 may be inclined toward the nozzle tube 243, and a portion corresponding to the groove 252 may be a rib to contact and fix the filter.
  • FIG. 5 is a diagram schematically showing some examples of the shape of the lip provided on the nozzle cap before the filter shown in FIG. 3 is attached.
  • FIG. 5A is an enlarged view of the lip 249 surrounded by a broken-line circle in FIG.
  • the lip 249 is preferably formed in advance so that the corner 254 has a suitably rounded shape in order to prevent interference due to the overlap with the adjacent lip when the filter is locked.
  • the width W 1 and length L 1 of the lip 249 can be selected as appropriate by those skilled in the art depending on the size (eg, diameter) of the filter used. For example, when using a filter having a diameter of 7 mm, the width W 1 of the lip 249 is preferably 1 mm to 3 mm.
  • the length L 1 of the lip 249 is preferably 1 mm ⁇ 3.5 mm.
  • the shape of the lip 249 is not limited to that shown in FIG.
  • FIG. 5 may have any shape as shown in FIGS. 5 (b) to 5 (d), for example.
  • FIG. 5 is an example of a lip 261 having a semicircular end
  • (c) is an example of a lip 262 having a trapezoidal shape with a short side toward the end
  • ( d) is an example of a lip 263 having a substantially parallelogram shape.
  • the filter 150 is inserted into the filter housing portion 246 provided with the plurality of lips 249 until the end portion is in contact with the base end portion 248. Thereafter, for example, ultrasonic treatment is performed on the lip 249 portion of the filter housing portion 246, and each lip 249 is folded to lock the filter 150.
  • This sonication is performed using means well known to those skilled in the art, and specific conditions required for sonication can be appropriately selected by those skilled in the art.
  • ultrasonic treatment refers to, for example, an operation of melting the thermoplastic resin by applying ultrasonic vibration when the lip 249 portion is made of the thermoplastic resin.
  • the filter 150 can be securely stored and fixed in the filter housing portion 246 only by the nozzle cap 240, for example, by dropping of the locking member or the filter or by shifting the filter. It is possible to eliminate the risk of the sample sample solution being used for measurement without being filtered during use.
  • FIG. 6 is a diagram schematically showing an example of the sample test container according to the present invention.
  • FIG. 6A is a front view of the sample test container after the nozzle cap shown in FIG. 1 is attached to the container base.
  • FIG. 8B is a front view of the sample test container for explaining an example of a state before the nozzle cap is attached to the container base.
  • the sample test container 100 of the present invention includes a container base 120 and a nozzle cap 140 for storing the sample liquid.
  • the container base 120 and the nozzle cap 140 are combined with each other as shown in FIG.
  • the container base 120 is not particularly limited as long as it can be attached to the nozzle cap 140.
  • FIG. 6 (b) is a front view of the sample test container 100 of the present invention for explaining an example of a state before the nozzle cap 140 is attached to the container base 120.
  • the container base 120 has a cylindrical shape or a shape tapered so as to be slightly reduced in the downward direction, and contains, for example, 0.1 mL to 2 mL, preferably 0.4 mL to 1 mL of the sample liquid. can do.
  • the container base 120 also includes a connection 124 that opens above it and is threaded on the outer surface.
  • the connecting portion 124 is set to a shape that can be screwed with a screw thread (not shown) provided on the inner surface of the cap portion 144 below the nozzle cap 140.
  • FIG. 7 is a cross-sectional view of the specimen test container of the present invention shown in FIG. 6 (b), schematically showing the cross sections of the container base and the nozzle cap.
  • the container base 120 and the nozzle cap 140 include, for example, a screw thread provided at a connection portion 124 of the container base 120 and a cap portion 144 of the nozzle cap 140. It can be attached and detached by screwing with a screw thread of a connecting portion 145 provided on the inner side surface.
  • the nozzle cap 140 is attached to the container base 120, there is no leakage from the attachment portion, and the connection of the container base 120 is performed so that the specimen test solution stored in the container 100 is discharged only from the dropping port 142. It is preferable that sufficient adhesion is maintained between the portion 124 and the connection portion 145 of the nozzle cap 140.
  • the container base 120 and the nozzle cap 140 are fixed by screwing between the connection portion 124 and the connection portion 145 . It is not limited to such a style.
  • the container base 120 and the nozzle cap 140 may be fitted and fixed by snap fitting.
  • the container base 120 is also preferably made of, for example, a transparent material so that the presence or absence of the sample liquid sample can be visually recognized from the outside. Furthermore, the container base 120 is also preferably made of a plastic material such as a thermoplastic resin similar to the nozzle cap.
  • the container base when the container base is made of a thermoplastic resin, the container base can also be formed by injection molding.
  • a sample collected through a collection tool such as a cotton swab is added to a diluent such as a buffer in the container base, and these are mixed to prepare a sample liquid.
  • a diluent such as a buffer in the container base
  • the diluted solution previously added into the container base and the opening sealed with an aluminum sheet or the like may be opened at the time of use, and the specimen may be added thereto.
  • the nozzle cap is fastened to the container base by, for example, screwing.
  • the sample sample solution thus prepared is dropped in a required amount, for example, onto a test plate included in the sample test kit through the dropping port.
  • examples of the analyte contained in the specimen are not necessarily limited, but include influenza virus, RS (Respiratory Synthetic) virus, adenovirus, group A streptococcus, pneumonia mycoplasma, Legionella, human metapneumovirus, norovirus, rotavirus.
  • Sapoviruses pathogenic microorganisms such as diarrhea adenovirus, or substances such as proteins derived from the pathogenic microorganisms, or antibodies against them, peptide hormones, steroids, bioactive amines, vitamins, prostaglandins, tetracyclines, etc.
  • the sample test container according to the present invention securely stores and fixes the filter without using the locking member, so that the sample liquid is filtered at the time of use due to, for example, dropping of the locking member or filter or displacement of the filter. This is a sample test container that can wipe out the risks used for measurement without any problems.
  • sample test kit includes a container for storing the sample sample solution and a test plate for assaying the characteristics of the measurement object contained in the sample sample solution.
  • the test plate constituting the present invention contains, for example, a capture substance and a detection reagent, and may be, for example, an immunochromatography method plate known in the art.
  • the capture substance examples include antibodies (for example, polyclonal antibodies and monoclonal antibodies) that specifically react and bind to bacteria, viruses, hormones, or other clinical markers.
  • a capturing substance can be immobilized on a predetermined membrane surface provided on the test plate by a method known to those skilled in the art. Immobilization of the capture substance on the membrane is performed, for example, by adsorbing a solution obtained by diluting the capture substance in a buffer or the like to the membrane and then drying it. The capture substance can be immobilized on the test plate, for example in a line.
  • the test plate when the specimen test kit of the present invention is used as a kit for diagnosing morbidity caused by an adenovirus or RS virus pathogen, the test plate contains an anti-adenovirus antibody or an anti-RS virus antibody as a capture substance. It is fixed.
  • the sample test kit of the present invention when used as a detection kit for detecting allergens such as clinical markers and foods, the test plate contains the clinical markers and allergies as capture substances.
  • An antibody against the substance is immobilized.
  • the type of antibody that can be immobilized on one test plate is not particularly limited, and one or more antibodies may be immobilized.
  • the detection reagent specifically binds to the object to be measured and can form a complex with the object to be measured.
  • the detection reagent when the object to be measured is an antigenic substance such as a virus, the detection reagent is an antibody against the virus and includes a labeled antibody. Examples of antibodies before labeling are similar to those that can be used for the capture reagent. Examples of substances used for labeling include enzymes, fluorescent / chemiluminescent labels, magnetic labels, radioisotopes, colloidal gold, beads, and colored latex.
  • Such a detection reagent is previously incorporated in a test plate by a method well known to those skilled in the art.
  • the test plate when the sample test kit of the present invention is used as a kit for diagnosing adenovirus or RS virus disease, the test plate contains a colloidal gold-labeled anti-adenovirus antibody or a colloidal gold-labeled anti-virus as a detection reagent.
  • RS virus antibody is incorporated.
  • the sample test kit of the present invention when used as a detection kit for detecting allergens such as clinical markers and foods, the test plate contains the clinical markers and allergies as detection reagents. An antibody against the substance is incorporated. It is not limited whether one or a plurality of measurement items are provided on one test plate.
  • the detection reagent may be added to the test plate after the sample test solution is added, instead of being incorporated in advance in the test plate.
  • the sample test kit of the present invention may also include a collection tool for collecting a sample.
  • collection tools include cotton swabs, collection tools, collection containers, brushes and the like.
  • the collection tool is preferably sterilized.
  • the sample test kit of the present invention may also contain a reaction stop solution for stopping the reaction between the enzyme and the substrate, for example, as necessary. Examples of such a reaction stop solution include citric acid and sulfuric acid.
  • the sample test kit of the present invention may include instructions for handling and use as necessary.
  • sample test kit of the present invention which is a case where the kit is an influenza kit and a nasal wipe is used as a sample, will be described.
  • a cotton swab 410 (collecting tool) obtained by wiping the subject's nasal cavity in a predetermined manner is immersed in the container base 120 containing the buffer 412. Thereafter, the cotton swab 410 is pulled up and down, for example, by moving it up and down in the buffer solution 10 times or more and finally handling it. In this way, the specimen sample solution is prepared in the container base 120.
  • the container base 120 and the nozzle cap 140 are firmly screwed together while the specimen sample solution 420 remains in the container base 120. Then, as shown in FIG.
  • doctors and the like are positive or negative for various influenza viruses (eg, positive for influenza A virus antigen, positive for influenza B virus antigen, influenza A virus antigen and It is possible to make a positive determination for any of the influenza B virus antigens, a negative for any of the influenza A virus antigens and the influenza B virus antigens, or a retest without proper display.
  • influenza viruses eg, positive for influenza A virus antigen, positive for influenza B virus antigen, influenza A virus antigen and It is possible to make a positive determination for any of the influenza B virus antigens, a negative for any of the influenza A virus antigens and the influenza B virus antigens, or a retest without proper display.
  • the present invention is useful, for example, in the medical field where a quick and efficient simple test is required without degrading the sensitivity and performance of the assay.
  • Sample test container 120 Container base 140,240 Nozzle cap 141 Nozzle main body 142,242 Drop port 143,243 Nozzle pipe 144 Cap part 146,246 Filter accommodating part 147,247 Open end 148,248 Base end part 149,249 Lip 150 Filter 252 Groove 410 Cotton swab 412 Buffer 420 Specimen sample solution 422 Filtered sample sample solution 430 Test plate 432 Drip section 434 Display window

Abstract

Provided are a nozzle cap for a specimen test container, and a specimen test container and specimen test kit using the same, wherein manufacturing complications are eliminated, and the risk of, during use, using unfiltered specimen test liquid for measurement, due to holding member or filter dislodgement or filter misalignment, is removed. The nozzle cap for a specimen test container according to the present invention configures a specimen test container by connecting with the open end of a container base section, said cap being provided with: a nozzle body that is provided with a cap part, which is connectable with the open end of the container base section, and a nozzle tube, which is for discharging the specimen test liquid through a drip opening; and a filter that is accommodated inside the nozzle body, wherein the nozzle body has a cylindrical filter accommodating section inside the cap part, and the filter is housed and held inside the filter accommodating section by multiple lip folds provided to the open end of the filter accommodating section.

Description

検体試験容器用ノズルキャップ、ならびにそれを用いた検体試験容器および検体試験キットNozzle cap for specimen test container, specimen test container and specimen test kit using the same
　本発明は、検体試験容器用ノズルキャップ、ならびにそれを用いた検体試験容器および検体試験キットに関する。 The present invention relates to a nozzle cap for a specimen test container, and a specimen test container and a specimen test kit using the same.
　ウイルスまたは細菌のような病原体の感染、妊娠の有無、血糖値などを、短時間で検出することのできる簡易の検査試験が開発されている。これらの簡易検査試験キットは、特別な設備を必要とすることなく、比較的簡易な操作を通じて安価に目的の項目についての測定を行うことができる。 A simple test that can detect in a short time the infection of pathogens such as viruses or bacteria, the presence or absence of pregnancy, and blood glucose level has been developed. These simple inspection test kits can measure a target item at a low cost through a relatively simple operation without requiring any special equipment.
　このような検査試験を行うためには、例えば、患者の咽頭や鼻腔から採取用具を用いて採取した拭い液や鼻汁などの分泌物または尿や便などの排泄物の一部を、検体試験容器中の緩衝液などに浮遊させて検体試料液を調製する。アッセイは、この検体試験容器中の検体試料液を、当該キットに含まれるテストプレートの所定位置に滴下することにより行われるが、例えば、検体試料液中の不要物を取り除くために、検体試料液は検体試料容器内のフィルタで濾過される。この濾過の性能は、アッセイの性能を大きく左右するものである。 In order to carry out such a test, for example, a part of secretions such as wiping liquid and nasal discharge or excrement such as urine and stool collected from a patient's pharynx and nasal cavity using a sampling tool is used as a specimen test container. Prepare a sample solution by suspending in a buffer solution. The assay is performed by dropping the specimen sample solution in the specimen test container onto a predetermined position of the test plate included in the kit. For example, in order to remove unnecessary substances in the specimen sample solution, the specimen sample solution is used. Is filtered by a filter in the specimen sample container. The performance of this filtration greatly affects the performance of the assay.
　ここで、従来の検体試験容器の一例を示す。図９は、従来の検体試験キットに含まれる検体試験容器の一例を模式的に表した図である。 Here, an example of a conventional specimen test container is shown. FIG. 9 is a diagram schematically showing an example of a sample test container included in a conventional sample test kit.
　従来の検体試験容器９００は、検体試料液を収容するための容器基部９２０と、検体試料液を濾過して滴下口９４２から排出するためのノズルキャップ９４０とを備える。容器基部９２０は、その上方において、開口しかつ外側面にねじ山が設けられた接続部９２４を備える。接続部９２４は、ノズルキャップ９４０の下方におけるキャップ９４４の内側面に設けられたねじ山（図示せず）と螺合可能な形状に設定されている。容器基部９２０およびノズルキャップ９４０はともに、ポリプロピレンなどの熱可塑性樹脂で成形されている。 The conventional specimen test container 900 includes a container base 920 for containing the specimen sample liquid, and a nozzle cap 940 for filtering the specimen sample liquid and discharging it from the dropping port 942. The container base 920 includes a connection portion 924 that is open and has a thread on the outer surface. The connecting portion 924 is set in a shape that can be screwed with a screw thread (not shown) provided on the inner surface of the cap 944 below the nozzle cap 940. Both the container base 920 and the nozzle cap 940 are formed of a thermoplastic resin such as polypropylene.
　図１０は、図９に示す従来の検体試験容器９００を構成するノズルキャップ９４０を模式的に表した図であって、（ａ）は、ノズルキャップ９４０の縦方向断面図であり、そして（ｂ）はノズルキャップ９４０の分解縦方向断面図である。 FIG. 10 is a diagram schematically showing a nozzle cap 940 constituting the conventional specimen test container 900 shown in FIG. 9, wherein (a) is a longitudinal sectional view of the nozzle cap 940, and (b) ) Is an exploded longitudinal sectional view of the nozzle cap 940.
　図１０の（ａ）に示すように、ノズルキャップ９４０は、滴下口９４２と連通するノズル管９４３を備えるノズル本体９４１とキャップ部分９４４とから構成されている。ノズル本体９４１の下端はキャップ部分９４４と一体的に成形されており、ノズル本体９４１の軸方向と略垂直な方向に設けられたキャップ部分９４４の基端部９４８には、キャップ部分９４４内において当該基端部９４８と略垂直な方向に延びる筒状のフィルタ収容部９４６内にフィルタ９５０が嵌め込まれている。フィルタ収容部９４６はまた、その外部から内部キャップ９６０が嵌め込みまたは螺合されており、フィルタ収容部９４６と内部キャップ９６０の内側壁９６４とが固定されている。なお、内部キャップ９６０の下端はフィルタ９５０の外径よりも幾分小さくなるように設計されたフィルタ孔９６２が設けられている。このようにして、フィルタ９５０はノズルキャップ９４０内の基端部９４８と、フィルタ収容部９４６と、内部キャップ９６０とで挟持かつ固定されている。検体試料液が滴下される際、検体試験容器内の検体試料液は、フィルタ孔９６２から、フィルタ９５０およびノズル管９４３を通過し、滴下口９４２を通じて外部に、例えば、液滴の形態にて排出される。 As shown in FIG. 10A, the nozzle cap 940 includes a nozzle body 941 having a nozzle tube 943 communicating with the dropping port 942 and a cap portion 944. The lower end of the nozzle body 941 is formed integrally with the cap portion 944, and the base end portion 948 of the cap portion 944 provided in a direction substantially perpendicular to the axial direction of the nozzle body 941 is within the cap portion 944. A filter 950 is fitted in a cylindrical filter housing portion 946 extending in a direction substantially perpendicular to the base end portion 948. The filter housing portion 946 is also fitted or screwed with an internal cap 960 from the outside, and the filter housing portion 946 and the inner wall 964 of the internal cap 960 are fixed. The lower end of the inner cap 960 is provided with a filter hole 962 designed to be somewhat smaller than the outer diameter of the filter 950. In this way, the filter 950 is sandwiched and fixed by the base end portion 948 in the nozzle cap 940, the filter housing portion 946, and the inner cap 960. When the specimen sample liquid is dropped, the specimen sample liquid in the specimen test container passes through the filter hole 962 through the filter 950 and the nozzle tube 943, and is discharged to the outside through the dropping port 942, for example, in the form of droplets. Is done.
　しかし、このような従来の検体試験容器９００には、いくつかの課題が残されている。例えば、図１０の（ｂ）に示すように、フィルタ９５０以外に、係止部材として内部キャップ９６０が必要となるため、ノズルキャップ９４０のみで少なくとも３つの部材で構成しなければならない点である。また、例えば、フィルタ９５０の外周を、係止部材の内部キャップ９６０で係止する構成となるため、内部キャップ９６０および／またはフィルタ９５０の脱落あるいはフィルタ９５０のズレによって使用時に検体試料液が濾過されることなく測定に使用されるというリスクを回避しなければならない点である。 However, some problems remain in the conventional specimen test container 900 as described above. For example, as shown in FIG. 10B, since an internal cap 960 is required as a locking member in addition to the filter 950, the nozzle cap 940 alone needs to be configured by at least three members. Further, for example, since the outer periphery of the filter 950 is configured to be locked by the internal cap 960 of the locking member, the sample liquid is filtered at the time of use due to the internal cap 960 and / or the filter 950 being dropped or the filter 950 being displaced. The risk of being used for measurement without having to be used is to be avoided.
　本発明は、上記問題の解決を課題とするものであり、その目的とするところは、製造上の煩雑さが解消され、かつ係止部材やフィルタの脱落あるいはフィルタのズレによって、使用時に検体試料液が濾過されることなく測定に使用されるリスクから解放された、検体試験容器用ノズルキャップ、ならびにそれを用いた検体試験容器および検体試験キットを提供することにある。 An object of the present invention is to solve the above-mentioned problems. The object of the present invention is to eliminate the inconvenience in manufacturing and to remove a specimen sample at the time of use due to dropping of a locking member or a filter or displacement of a filter. The object is to provide a nozzle cap for a specimen test container, and a specimen test container and a specimen test kit using the same, which are free from the risk of being used for measurement without being filtered.
　本発明は、容器基部の開放端と接続して検体試験容器を構成し得る、ノズルキャップであって、
　該容器基部の開放端と接続可能なキャップ部分と検体試料液を滴下口から排出するためのノズル管とを備える、ノズル本体；および
　該ノズル本体内に収容されたフィルタ；
　を備え、
　ここで、
　該ノズル本体が、該キャップ部分の内部に筒状のフィルタ収容部を有し、そして
　該フィルタが、該フィルタ収容部の該開放端に設けられた複数のリップの折畳みによって該フィルタ収容部内に収容かつ係止されている、ノズルキャップである。 The present invention is a nozzle cap that can be connected to the open end of the container base to constitute a specimen test container,
A nozzle body comprising a cap portion connectable to the open end of the container base and a nozzle tube for discharging the sample liquid from the dropping port; and a filter accommodated in the nozzle body;
With
here,
The nozzle body has a cylindrical filter housing portion inside the cap portion, and the filter is housed in the filter housing portion by folding a plurality of lips provided at the open end of the filter housing portion. And a nozzle cap that is locked.
　１つの実施形態では、上記複数のリップは、上記フィルタ収容部の上記開放端上で略等間隔となるように設けられている。 In one embodiment, the plurality of lips are provided at substantially equal intervals on the open end of the filter housing portion.
　１つの実施形態では、上記複数のリップの数は２個から１６個である。 In one embodiment, the number of the plurality of lips is 2 to 16.
　１つの実施形態では、上記ノズル本体は熱可塑性樹脂で構成されている。 In one embodiment, the nozzle body is made of a thermoplastic resin.
　さらなる実施形態では、上記複数のリップの折畳みによる上記フィルタの係止は超音波処理により行われている。 In a further embodiment, locking of the filter by folding the plurality of lips is performed by ultrasonic treatment.
　本発明はまた、検体試験を行うための検体試料液を収容するための容器であって、上記ノズルキャップ；および検体試料液を収容するための容器基部；を備える、容器である。 The present invention is also a container for storing a sample liquid for performing a sample test, the container including the nozzle cap; and a container base for storing the sample liquid.
　本発明はまた、上記検体試料液を収容するための容器と、
　該検体試料液に含まれる被測定物の特性をアッセイするためのテストプレートと、
を含む、検体試験キットである。 The present invention also includes a container for storing the specimen sample solution,
A test plate for assaying the characteristics of an object to be measured contained in the sample liquid;
Is a sample test kit.
　１つの実施形態では、本発明の検体試験キットはさらに検体を採取するための採取用具を含む。 In one embodiment, the sample test kit of the present invention further includes a collection tool for collecting a sample.
　本発明によれば、製造上の煩雑さから解消され、製造コストを削減することができる。本発明によれば、例えば、係止部材やフィルタの脱落あるいはフィルタのズレによって、使用時に検体試料液が濾過されることなく測定に使用されるリスクから解放されるため、検体試料キットによるアッセイの際に、検体試料液中の不要物が検体試料キットのテストプレートに誤って滴下されることも回避することができる。これにより、短時間で被測定物をより高精度に検出することが可能となる。 According to the present invention, the manufacturing complexity can be eliminated, and the manufacturing cost can be reduced. According to the present invention, for example, the specimen sample liquid is released from the risk of being used for measurement without being filtered by use of the locking member or the filter, or the displacement of the filter. In this case, it is possible to avoid that unnecessary substances in the sample liquid are accidentally dropped on the test plate of the sample sample kit. As a result, the object to be measured can be detected with higher accuracy in a short time.
本発明のノズルキャップの一例を説明するための図であって、当該キャップの模式断面図である。It is a figure for demonstrating an example of the nozzle cap of this invention, Comprising: It is a schematic cross section of the said cap. 図１に示す本発明のノズルキャップの底面図である。It is a bottom view of the nozzle cap of this invention shown in FIG. 本発明の検体試験容器を構成するノズルキャップを模式的に表す図であって、フィルタを取り付ける前の状態を説明するための当該ノズルキャップおよびフィルタの断面図である。It is a figure which represents typically the nozzle cap which comprises the sample test container of this invention, Comprising: It is sectional drawing of the said nozzle cap and filter for demonstrating the state before attaching a filter. 図３に示すフィルタを取り付ける前のノズルキャップの模式底面図である。It is a model bottom view of the nozzle cap before attaching the filter shown in FIG. 図３に示すフィルタを取り付ける前のノズルキャップに設けられたリップの形状のいくつかの例を模式的に表す図である。It is a figure which represents typically some examples of the shape of the lip | rip provided in the nozzle cap before attaching the filter shown in FIG. 本発明の検体試験容器の一例を模式的に表した図であって、（ａ）は、容器基部に図１に示すノズルキャップを取り付けた後の当該検体試験容器の正面図であり、（ｂ）は、容器基部に当該ノズルキャップと取り付ける前の状態の一例を説明する当該検体試験容器の正面図である。It is the figure which represented typically an example of the sample test container of this invention, Comprising: (a) is a front view of the said sample test container after attaching the nozzle cap shown in FIG. ) Is a front view of the sample test container for explaining an example of a state before the nozzle cap is attached to the container base. 図６の（ｂ）に示す、本発明の検体試験容器の断面図であって、容器基部およびノズルキャップのそれぞれの断面を模式的に表す図である。It is sectional drawing of the sample test container of this invention shown in (b) of FIG. 6, Comprising: It is a figure which represents typically each cross section of a container base and a nozzle cap. 本発明の検体試験キットの一例を表す図であって、（ａ）は、採取した検体を、容器基部の希釈液中に添加する様子を模式的に表す図であり、（ｂ）は検体を添加した容器基部にノズルキャップを被せる様子を模式的に表す図であり、そして（ｃ）は、（ｂ）の検体試験容器を通じて濾過された検体試験液を、目的のテストプレートの滴下部に滴下する様子を模式的に表す図である。It is a figure showing an example of the sample test kit of this invention, Comprising: (a) is a figure showing typically a mode that the extract | collected sample is added in the dilution liquid of a container base, (b) is a figure showing a sample. It is a figure which represents a mode that a nozzle cap is put on the added container base, and (c) is dripping the sample test liquid filtered through the sample test container of (b) to the dripping part of the target test plate. It is a figure which represents a mode that it does. 従来の検体試験キットに含まれる検体試験容器の一例を模式的に表した図である。It is the figure which represented typically an example of the sample test container contained in the conventional sample test kit. 図９に示す従来の検体試験容器を構成するノズルキャップを模式的に表した図であって、（ａ）は、ノズルキャップの縦方向断面図であり、そして（ｂ）はノズルキャップの分解縦方向断面図である。FIG. 10 is a diagram schematically illustrating a nozzle cap constituting the conventional specimen test container shown in FIG. 9, wherein (a) is a longitudinal sectional view of the nozzle cap, and (b) is an exploded longitudinal view of the nozzle cap. FIG.
　以下、本発明を、図面を用いて説明する。 Hereinafter, the present invention will be described with reference to the drawings.
（検体試験容器用ノズルキャップ）
　本発明の検体試験容器用ノズルキャップ（以下「ノズルキャップ」）は、容器基部の開放端と接続して検体試験容器を構成し得る。ここで、本明細書中にて用いられる用語「検体試験容器」とは、検体試験を行うための種々の検体試料液を収容するための容器を指して言う。 (Nozzle cap for specimen test container)
The specimen test container nozzle cap of the present invention (hereinafter referred to as “nozzle cap”) can be connected to the open end of the container base to constitute a specimen test container. Here, the term “specimen test container” used in this specification refers to a container for containing various specimen sample liquids for performing a specimen test.
　図１は、本発明のノズルキャップの一例を説明するための図であって、当該キャップの模式断面図である。 FIG. 1 is a view for explaining an example of a nozzle cap of the present invention, and is a schematic cross-sectional view of the cap.
　図１に示すように、本発明のノズルキャップ１４０は、ノズル本体１４１とフィルタ１５０とから構成されている。さらにノズル本体１４１は、ノズル管１４３とキャップ部分１４４とから構成されている。本発明においては、製造工程の煩雑さを解消する目的で、ノズル管１４３とキャップ部分１４４とは一体に成形されていることが好ましい。 As shown in FIG. 1, the nozzle cap 140 of the present invention includes a nozzle body 141 and a filter 150. Further, the nozzle body 141 is composed of a nozzle tube 143 and a cap portion 144. In the present invention, it is preferable that the nozzle tube 143 and the cap portion 144 are integrally formed for the purpose of eliminating the complexity of the manufacturing process.
　ノズル管１４３は、濾過された検体試料液を排出（例えば、滴下）するための滴下口１４２を有する。ノズル管１４３は、例えば、図面の上方から下方にかけて拡径するようにテーパーをかけた形状を有する。ノズル管１４３の下端は、フィルタ１５０と接していてもよく、あるいは所定の間隙をおいて配置されていてもよい。滴下口１４２の形状は、必ずしも限定されないが、例えば、円形であり、その外径が好ましくは１ｍｍ～５ｍｍ、より好ましくは２ｍｍ～４ｍｍである。ノズル管１４３の長さは、好ましくは８ｍｍ～２０ｍｍ、より好ましくは１０ｍｍ～１５ｍｍである。 The nozzle tube 143 has a dripping port 142 for discharging (for example, dripping) the filtered sample liquid. The nozzle tube 143 has, for example, a tapered shape so as to increase in diameter from the upper side to the lower side of the drawing. The lower end of the nozzle tube 143 may be in contact with the filter 150 or may be arranged with a predetermined gap. The shape of the dripping port 142 is not necessarily limited, but is, for example, circular, and the outer diameter is preferably 1 mm to 5 mm, more preferably 2 mm to 4 mm. The length of the nozzle tube 143 is preferably 8 mm to 20 mm, more preferably 10 mm to 15 mm.
　キャップ部分１４４の内部には、上記ノズル管１４３の軸方向に沿って（例えば、ノズル管１４３の軸方向と略平行となるように）延びる筒状のフィルタ収容部１４６が設けられている。フィルタ収容部１４６は好ましくは円筒状を有する。これにより、滴下口１４２とノズル管１４３とフィルタ収容部１４６とが連通し、検体試験容器内の検体試料液をフィルタ収容部１４６から、ノズル管１４３を通じて滴下口１４２に排出することができる。さらにフィルタ収容部１４６には、内部にフィルタ１５０が収容されている。フィルタ収容部１４６の内径は、使用するフィルタの外径と一致するか、あるいはと当該フィルタの外径よりも僅かに小さい長さとなるように設計されることが好ましい。フィルタ収容部１４６の内径は、例えば２ｍｍ～１５ｍｍであり、好ましくは４ｍｍ～１２ｍｍである。フィルタ収容部１４６はまた、図面の上方（すなわち、ノズル管１４３が設けられている側）に向かって僅かに縮径するように設計されていることが好ましい。収容されるフィルタ１５０とフィルタ収容部１４６の内壁との間の密着性を一層向上させるためである。 Inside the cap portion 144, a cylindrical filter housing portion 146 is provided that extends along the axial direction of the nozzle tube 143 (for example, substantially parallel to the axial direction of the nozzle tube 143). The filter accommodating portion 146 preferably has a cylindrical shape. Thereby, the dropping port 142, the nozzle tube 143, and the filter housing portion 146 communicate with each other, and the sample liquid in the sample test container can be discharged from the filter housing portion 146 to the dropping port 142 through the nozzle tube 143. Further, the filter housing portion 146 houses the filter 150 therein. It is preferable that the inner diameter of the filter housing portion 146 is designed to match the outer diameter of the filter to be used, or to be slightly smaller than the outer diameter of the filter. The inner diameter of the filter accommodating portion 146 is, for example, 2 mm to 15 mm, preferably 4 mm to 12 mm. The filter housing portion 146 is also preferably designed so as to be slightly reduced in diameter toward the top of the drawing (that is, the side where the nozzle tube 143 is provided). This is to further improve the adhesion between the accommodated filter 150 and the inner wall of the filter accommodating portion 146.
　フィルタ１５０は、フィルタ収容部１４６の開放端１４７に設けられた複数のリップ１４９の折畳みによってフィルタ収容部１４６内に収容かつ係止されている。すなわち、本発明の１つの実施形態では、複数のリップ１４９は、フィルタ収容部１４６の開放端１４７側でフィルタ収容部１４６と一体に成形されており、当該リップ１４９の端部がフィルタ収容部１４６の中心軸方向に指向することにより、フィルタ１５０が複数のリップ１４９によってフィルタ収容部１４６内に収容かつ係止されている。ここで、本明細書中に用いられる用語「複数のリップの折畳み」とは、図１に示すようにフィルタ収容部と一体的に成形された複数のリップがフィルタ収容部１４６の中心軸方向に（例えば、略９０°の角度で）曲がった状態；およびフィルタ収容部と一体的に成形された複数のリップの全部または一部が溶融してフィルタ収容部の中心軸方向に向かって凸部を形成する状態（例えば、複数のリップが溶融し、フィルタ収容部内でフィルタを係止する状態）；ならびにこれらを組み合わせた状態；を包含していう。本発明において、フィルタ１５０は、フィルタ収容部１４６と、複数のリップ１４９と、ノズル本体１４１のノズル管１４３における他端（滴下口１４２と反対の端部）に相当する、キャップ部分１４４の基端部１４８との間で固定されていることが好ましく、当該固定にあたりフィルタ１５０と、フィルタ収容部１４６、複数のリップ１４９、および基端部１４８との間で間隙が形成されてないようにそれぞれ当接していることがさらに好ましい。 The filter 150 is housed and locked in the filter housing portion 146 by folding a plurality of lips 149 provided at the open end 147 of the filter housing portion 146. That is, in one embodiment of the present invention, the plurality of lips 149 are formed integrally with the filter housing portion 146 on the open end 147 side of the filter housing portion 146, and the end portion of the lip 149 is the filter housing portion 146. The filter 150 is housed and locked in the filter housing portion 146 by a plurality of lips 149. Here, the term “folding of a plurality of lips” used in the present specification means that a plurality of lips formed integrally with the filter housing portion are formed in the direction of the central axis of the filter housing portion 146 as shown in FIG. A bent state (for example, at an angle of approximately 90 °); and all or a part of the plurality of lips formed integrally with the filter housing portion are melted to form a convex portion toward the central axis of the filter housing portion. The state to be formed (for example, a state in which a plurality of lips are melted and the filter is locked in the filter housing portion); In the present invention, the filter 150 includes a filter housing portion 146, a plurality of lips 149, and a base end of the cap portion 144 corresponding to the other end (the end opposite to the dripping port 142) of the nozzle pipe 143 of the nozzle body 141. It is preferable that the filter 150 is fixed between the filter 150 and the filter accommodating portion 146, the plurality of lips 149, and the base end portion 148 so that no gap is formed between them. More preferably, they are in contact with each other.
　図２は、図１に示す本発明のノズルキャップの底面図である。 FIG. 2 is a bottom view of the nozzle cap of the present invention shown in FIG.
　ノズルキャップ１４０において、複数のリップ１４９は、好ましくはフィルタ収容部１４６の開放端１４７上で略等間隔となるように設けられている。本発明においては、リップ１４９が略等間隔でフィルタ１５０の周囲に配置された状態で、好ましくはフィルタ収容部１４６の中心方向に向かって折畳まれていることにより、フィルタ１５０の周囲はより均等に係止され得、フィルタ収容部１４６内でのフィルタ１５０の安定性を高めることができる。さらに、本発明において、１つのノズルキャップ１４０に設けられるリップ１４９の数は、折畳みによって互いに重なり合って干渉しない限り必ずしも限定されないが、好ましくは２個～１６個である。リップ１４９の数が１個ではフィルタ１５０を係止が適切に行えないおそれがあり、フィルタ収容部１４６内でのフィルタ１５０の安定性が保持されない場合がある。リップ１４９の数が１６個を超えると、隣接するリップ同士が重なりあって干渉し、結果としてフィルタ１５０の係止を妨げるだけでなく、フィルタ１５０の周囲がより多くのリップ１４９で覆われることとなる。フィルタ１５０の濾過面積が減少することにより、濾過効率が低下する場合がある。 In the nozzle cap 140, the plurality of lips 149 are preferably provided at substantially equal intervals on the open end 147 of the filter housing portion 146. In the present invention, the periphery of the filter 150 is more evenly formed by folding the filter lip 149 toward the center of the filter housing portion 146 in a state where the lips 149 are arranged around the filter 150 at substantially equal intervals. The stability of the filter 150 in the filter housing part 146 can be increased. Further, in the present invention, the number of lips 149 provided in one nozzle cap 140 is not necessarily limited as long as it does not overlap and interfere with each other by folding, but is preferably 2 to 16. If the number of lips 149 is one, the filter 150 may not be properly locked, and the stability of the filter 150 in the filter housing portion 146 may not be maintained. If the number of lips 149 exceeds 16, adjacent lips overlap and interfere with each other, resulting in not only preventing the filter 150 from being locked, but also surrounding the filter 150 with more lips 149. Become. As the filtration area of the filter 150 decreases, the filtration efficiency may decrease.
　本発明のノズルキャップ１４０は、内容物の検体試料液の有無を外部から視認することができるように、例えば透明な材料で構成されていることが好ましい。さらに、ノズルキャップ１４０は、例えば、熱可塑性樹脂などのプラスチック材料から構成されていることが好ましい。 The nozzle cap 140 of the present invention is preferably made of, for example, a transparent material so that the presence or absence of the sample liquid sample can be visually recognized from the outside. Further, the nozzle cap 140 is preferably made of a plastic material such as a thermoplastic resin.
　熱可塑性樹脂の例としては、必ずしも限定されないが、ポリプロピレン、ポリエチレン、ポリ塩化ビニル、ポリエチレンテレフタレート、ポリスチレンなどが挙げられる。耐薬品性および汎用性に優れるという点で、ポリエチレンまたはポリプロピレンが好ましい。本発明において、ノズルキャップ１４０について、上記のような熱可塑性樹脂を用いることにより、例えば、射出成型により成形可能であり、かつ複数のリップ１４９によるフィルタ１５０の固定が、例えば、後述するような超音波処理によって達成され得る。 Examples of thermoplastic resins include, but are not necessarily limited to, polypropylene, polyethylene, polyvinyl chloride, polyethylene terephthalate, polystyrene and the like. From the viewpoint of excellent chemical resistance and versatility, polyethylene or polypropylene is preferable. In the present invention, the nozzle cap 140 can be molded by, for example, injection molding by using the thermoplastic resin as described above, and the filter 150 can be fixed by a plurality of lips 149, for example, as described later. It can be achieved by sonication.
　ノズルキャップ１４０内に収容されるフィルタ１５０の材料は特に限定されず、従来の検査試験キットに含まれる検体試験容器に採用されるフィルタ材料が使用され得る。 The material of the filter 150 accommodated in the nozzle cap 140 is not particularly limited, and a filter material employed in a specimen test container included in a conventional test kit can be used.
　フィルタ材料は、例えば精密ろ過に使用され得る材料である。フィルタ材料の例としては、セルロース、ガラス繊維、シリカ繊維、ニトロセルロース、セルロースエステル、ポリエーテルスルホン、ポリスルホン、四フッ化エチレン樹脂、フッ化ビニリデン樹脂、ポリカーボネート、ポリプロピレン、ポリアミド、ナイロン６，６、ポリエステル、コットン、およびステンレススチール繊維、ならびにこれらの組合せが挙げられる。フィルタ１５０の厚みは特に限定されず、当業者によって任意の厚みが選択され得る。 The filter material is a material that can be used for microfiltration, for example. Examples of filter materials are cellulose, glass fiber, silica fiber, nitrocellulose, cellulose ester, polyethersulfone, polysulfone, tetrafluoroethylene resin, vinylidene fluoride resin, polycarbonate, polypropylene, polyamide, nylon 6,6, polyester , Cotton, and stainless steel fibers, and combinations thereof. The thickness of the filter 150 is not particularly limited, and any thickness can be selected by those skilled in the art.
　図３は、本発明の検体試験容器を構成するノズルキャップを模式的に表す図であって、フィルタを取り付ける前の状態を説明するための当該ノズルキャップおよびフィルタの断面図である。 FIG. 3 is a diagram schematically showing a nozzle cap constituting the specimen test container of the present invention, and is a sectional view of the nozzle cap and the filter for explaining a state before the filter is attached.
　フィルタを取り付ける前のノズルキャップ２４０は、予め射出成型によって滴下口２４２、ノズル管２４３、およびフィルタ収容部２４６が成形されている。リップ２４９は、フィルタ収容部２４６の開放端２４７上で、ノズル管２４３の軸方向に沿って（すなわち、ノズル管２４３の軸方向と略平行な方向となるように）設けられている。なお、フィルタ収容部２４６の開放端２４７は、リップ２４９と略垂直（すなわち、ノズル管２４３の軸方向と直行する方向）となるような平面を有していることが好ましい。 The nozzle cap 240 before the filter is attached has a dripping port 242, a nozzle tube 243, and a filter housing portion 246 formed in advance by injection molding. The lip 249 is provided on the open end 247 of the filter housing portion 246 along the axial direction of the nozzle tube 243 (that is, in a direction substantially parallel to the axial direction of the nozzle tube 243). The open end 247 of the filter housing portion 246 preferably has a plane that is substantially perpendicular to the lip 249 (that is, a direction perpendicular to the axial direction of the nozzle tube 243).
　図４は、図３に示すノズルキャップ２４０の模式底面図である。 FIG. 4 is a schematic bottom view of the nozzle cap 240 shown in FIG.
　ノズルキャップ２４０の底面において、基端部２４８は、例えば、ノズル管２４３の軸方向と直行する方向に略平坦な平面を有し、収容されるフィルタと密着して、フィルタ収容部内でフィルタを一層適切に固定することができる。さらに、基端部２４８には、フィルタ収容部２４６の周囲から中央のノズル管２４３の端部に向かって複数の溝２５２が設けられている。容器基部からフィルタを介して濾過された検体試験液は、これら溝２５２を通ってノズル管２４３に集められ、滴下口２４２から外部に排出される。なお、図４では、基端部２４８がフィルタと密着可能となるように平坦であり、適宜溝２５２が設けられる構造が記載されているが、本発明は必ずしもこのような形態に限定されない。例えば、基端部２４８に相当する部分がノズル管２４３に向かって傾斜を形成し、一方溝２５２に相当する部分がリブとなってフィルタと接触し固定する構造を有するものであってもよい。 At the bottom surface of the nozzle cap 240, the base end portion 248 has, for example, a substantially flat plane in a direction perpendicular to the axial direction of the nozzle tube 243, and is in close contact with the filter to be accommodated so that the filter is further layered in the filter accommodating portion. Can be fixed properly. Further, the base end portion 248 is provided with a plurality of grooves 252 from the periphery of the filter housing portion 246 toward the end portion of the central nozzle tube 243. The specimen test solution filtered from the container base through the filter is collected in the nozzle tube 243 through the grooves 252 and discharged from the dropping port 242 to the outside. 4 illustrates a structure in which the base end portion 248 is flat so that the base end portion 248 can be in close contact with the filter and the groove 252 is appropriately provided, but the present invention is not necessarily limited to such a form. For example, a portion corresponding to the base end portion 248 may be inclined toward the nozzle tube 243, and a portion corresponding to the groove 252 may be a rib to contact and fix the filter.
　図５は、図３に示すフィルタを取り付ける前のノズルキャップに設けられたリップの形状のいくつか例を模式的に表す図である。 FIG. 5 is a diagram schematically showing some examples of the shape of the lip provided on the nozzle cap before the filter shown in FIG. 3 is attached.
　図５の（ａ）は、図３において破線の円で囲ったリップ２４９の拡大図である。リップ２４９は、フィルタを係止する際に隣接するリップとの重なりによる干渉を防止するため、予め角２５４が適度に丸みを帯びた形状を有するように成形されていることが好ましい。リップ２４９の幅Ｗ１および長さＬ１は、使用するフィルタの大きさ（例えば、直径）に応じて当業者によって適切な幅および長さが選択され得る。例えば、直径７ｍｍのフィルタを使用する場合、リップ２４９の幅Ｗ１は好ましくは１ｍｍ～３ｍｍである。リップ２４９の長さＬ１は好ましくは１ｍｍ～３．５ｍｍである。本発明において、リップ２４９の形状は、図５の（ａ）に示されるもののみに限定されず、例えば、図５の（ｂ）～（ｄ）に示すような任意の形状を有し得る。例えば、図５の（ｂ）は半円状の端部を有するリップ２６１の例であり、（ｃ）は端部に向かって短辺となる台形形状を有するリップ２６２の例であり、そして（ｄ）は略平行四辺形の形状を有するリップ２６３の例である。 FIG. 5A is an enlarged view of the lip 249 surrounded by a broken-line circle in FIG. The lip 249 is preferably formed in advance so that the corner 254 has a suitably rounded shape in order to prevent interference due to the overlap with the adjacent lip when the filter is locked. The width W 1 and length L 1 of the lip 249 can be selected as appropriate by those skilled in the art depending on the size (eg, diameter) of the filter used. For example, when using a filter having a diameter of 7 mm, the width W 1 of the lip 249 is preferably 1 mm to 3 mm. The length L 1 of the lip 249 is preferably 1 mm ~ 3.5 mm. In the present invention, the shape of the lip 249 is not limited to that shown in FIG. 5 (a), and may have any shape as shown in FIGS. 5 (b) to 5 (d), for example. For example, (b) in FIG. 5 is an example of a lip 261 having a semicircular end, (c) is an example of a lip 262 having a trapezoidal shape with a short side toward the end, and ( d) is an example of a lip 263 having a substantially parallelogram shape.
　再び図３を参照すると、このような複数のリップ２４９が設けられたフィルタ収容部２４６にフィルタ１５０が、端部が基端部２４８に接するまで嵌挿される。その後、このフィルタ収容部２４６のリップ２４９部分に対して例えば超音波処理が行われ、各リップ２４９が折畳まれてフィルタ１５０を係止する。この超音波処理は当業者に周知の手段を用いて行われ、超音波処理に要する具体的条件は当業者によって適宜選択され得る。なお、このような超音波処理とは、例えば、リップ２４９部分が上記熱可塑性樹脂で構成されている場合、超音波振動を加えることにより熱可塑性樹脂を溶融する操作をいう。 Referring to FIG. 3 again, the filter 150 is inserted into the filter housing portion 246 provided with the plurality of lips 249 until the end portion is in contact with the base end portion 248. Thereafter, for example, ultrasonic treatment is performed on the lip 249 portion of the filter housing portion 246, and each lip 249 is folded to lock the filter 150. This sonication is performed using means well known to those skilled in the art, and specific conditions required for sonication can be appropriately selected by those skilled in the art. Note that such ultrasonic treatment refers to, for example, an operation of melting the thermoplastic resin by applying ultrasonic vibration when the lip 249 portion is made of the thermoplastic resin.
　これにより、係止部材を使用することなく、ノズルキャップ２４０のみでフィルタ１５０をフィルタ収容部２４６内に確実に収容かつ固定することで、例えば、係止部材やフィルタの脱落あるいはフィルタのズレによって、使用時に検体試料液が濾過されることなく測定に使用されるリスクを一掃することができる。 Thereby, without using a locking member, the filter 150 can be securely stored and fixed in the filter housing portion 246 only by the nozzle cap 240, for example, by dropping of the locking member or the filter or by shifting the filter. It is possible to eliminate the risk of the sample sample solution being used for measurement without being filtered during use.
（検体試験容器）
　図６は、本発明の検体試験容器の一例を模式的に表した図であって、（ａ）は、容器基部に図１に示すノズルキャップを取り付けた後の当該検体試験容器の正面図であり、（ｂ）は、容器基部に当該ノズルキャップと取り付ける前の状態の一例を説明する当該検体試験容器の正面図である。 (Sample test container)
FIG. 6 is a diagram schematically showing an example of the sample test container according to the present invention. FIG. 6A is a front view of the sample test container after the nozzle cap shown in FIG. 1 is attached to the container base. FIG. 8B is a front view of the sample test container for explaining an example of a state before the nozzle cap is attached to the container base.
　図６の（ａ）に示すように、本発明の検体試験容器１００は、検体試料液を収容するための容器基部１２０とノズルキャップ１４０とを備える。容器基部１２０およびノズルキャップ１４０は、使用の際、図６の（ａ）に示すように互いに組み合わされる。なお、容器基部１２０は、ノズルキャップ１４０に取り付け可能なものであれば、特に限定されない。 As shown in FIG. 6A, the sample test container 100 of the present invention includes a container base 120 and a nozzle cap 140 for storing the sample liquid. The container base 120 and the nozzle cap 140 are combined with each other as shown in FIG. The container base 120 is not particularly limited as long as it can be attached to the nozzle cap 140.
　図６の（ｂ）は、容器基部１２０にノズルキャップ１４０を取り付ける前の状態の一例を説明するための、本発明の当該検体試験容器１００の正面図である。例えば、容器基部１２０は、円筒または下方に向かって僅かに縮径するようにテーパーをかけた形状を有し、例えば、０．１ｍＬ～２ｍＬ、好ましくは０．４ｍＬ～１ｍＬの検体試料液を収容することができる。容器基部１２０はまた、その上方において開口しかつ外側面にねじ山が設けられた接続部１２４を備える。接続部１２４は、ノズルキャップ１４０の下方におけるキャップ部分１４４の内側面に設けられたねじ山（図示せず）と螺合可能な形状に設定されている。 6 (b) is a front view of the sample test container 100 of the present invention for explaining an example of a state before the nozzle cap 140 is attached to the container base 120. FIG. For example, the container base 120 has a cylindrical shape or a shape tapered so as to be slightly reduced in the downward direction, and contains, for example, 0.1 mL to 2 mL, preferably 0.4 mL to 1 mL of the sample liquid. can do. The container base 120 also includes a connection 124 that opens above it and is threaded on the outer surface. The connecting portion 124 is set to a shape that can be screwed with a screw thread (not shown) provided on the inner surface of the cap portion 144 below the nozzle cap 140.
　図７は、図６の（ｂ）に示す、本発明の検体試験容器の断面図であって、容器基部およびノズルキャップのそれぞれの断面を模式的に表す図である。 FIG. 7 is a cross-sectional view of the specimen test container of the present invention shown in FIG. 6 (b), schematically showing the cross sections of the container base and the nozzle cap.
　図７に示すように、本発明の検体試験容器１００において、容器基部１２０とノズルキャップ１４０とは、例えば、容器基部１２０の接続部１２４に設けられたねじ山と、ノズルキャップ１４０のキャップ部分１４４の内側面に設けられた接続部１４５のねじ山との螺合により着脱可能である。また、容器基部１２０にノズルキャップ１４０を取り付けた際、取付け部分からの漏液がなく、容器１００内に収容された検体試験液が滴下口１４２のみから排出されるように、容器基部１２０の接続部１２４とノズルキャップ１４０の接続部１４５との間に充分な密着性が保持されていることが好ましい。 As shown in FIG. 7, in the sample test container 100 of the present invention, the container base 120 and the nozzle cap 140 include, for example, a screw thread provided at a connection portion 124 of the container base 120 and a cap portion 144 of the nozzle cap 140. It can be attached and detached by screwing with a screw thread of a connecting portion 145 provided on the inner side surface. In addition, when the nozzle cap 140 is attached to the container base 120, there is no leakage from the attachment portion, and the connection of the container base 120 is performed so that the specimen test solution stored in the container 100 is discharged only from the dropping port 142. It is preferable that sufficient adhesion is maintained between the portion 124 and the connection portion 145 of the nozzle cap 140.
　なお、本実施形態においては、上記の通り、容器基部１２０とノズルキャップ１４０との固定様式は、接続部１２４と接続部１４５との間の螺合による場合の例を説明したが、本発明はこのような様式に限定されない。例えば、容器基部１２０とノズルキャップ１４０とをスナップフィットにより嵌合して固定するものであってもよい。 In the present embodiment, as described above, the example in which the container base 120 and the nozzle cap 140 are fixed by screwing between the connection portion 124 and the connection portion 145 has been described. It is not limited to such a style. For example, the container base 120 and the nozzle cap 140 may be fitted and fixed by snap fitting.
　本発明の検体試験容器１００において、容器基部１２０もまた、内容物の検体試料液の有無を外部から視認することができるように、例えば透明な材料で構成されていることが好ましい。さらに、容器基部１２０もまた、例えば、上記ノズルキャップと同様の熱可塑性樹脂などのプラスチック材料から構成されていることが好ましい。 In the sample test container 100 of the present invention, the container base 120 is also preferably made of, for example, a transparent material so that the presence or absence of the sample liquid sample can be visually recognized from the outside. Furthermore, the container base 120 is also preferably made of a plastic material such as a thermoplastic resin similar to the nozzle cap.
　本発明の検体試験容器において、例えば、容器基部が熱可塑性樹脂で構成されている場合、当該容器基部もまた射出成型によって成形することができる。 In the sample test container of the present invention, for example, when the container base is made of a thermoplastic resin, the container base can also be formed by injection molding.
　本発明の検体試験容器では、例えば綿棒などの採取器具を通じて採取された検体は、容器基部内の緩衝液などの希釈液に添加され、これらを混合して検体試料液が調製される。なお、本発明においては、当該希釈液が予め容器基部内に添加されかつ開口部をアルミニウムシート等で密封したものを使用時に開封し、ここに検体を添加するものであってもよい。その後、容器基部にノズルキャップが、例えば螺合により緊合される。こうして調製された検体試料液は、滴下口を通じて必要量が例えば、検体試験キットに含まれるテストプレートに滴下される。 In the sample test container of the present invention, for example, a sample collected through a collection tool such as a cotton swab is added to a diluent such as a buffer in the container base, and these are mixed to prepare a sample liquid. In the present invention, the diluted solution previously added into the container base and the opening sealed with an aluminum sheet or the like may be opened at the time of use, and the specimen may be added thereto. Thereafter, the nozzle cap is fastened to the container base by, for example, screwing. The sample sample solution thus prepared is dropped in a required amount, for example, onto a test plate included in the sample test kit through the dropping port.
　本発明の検体試験容器に収容可能な検体の例としては、鼻腔拭い液および咽頭拭い液などの拭い液；鼻汁、喀痰、便、尿などの排泄物；血液；組織；ならびに細胞；が挙げられる。さらに検体中に含まれる被測定物の例としては、必ずしも限定されないが、インフルエンザウイルス、ＲＳ（Ｒｅｓｐｉｒａｔｏｒｙ　Ｓｙｎｓｙｔｉａｌ）ウイルス、アデノウイルス、Ａ群溶連菌、肺炎マイコプラズマ、レジオネラ、ヒトメタニューモウイルス、ノロウイルス、ロタウイルス、サポウイルス、下痢症アデノウイルス等の病原微生物、もしくは当該病原微生物由来のタンパク質等の物質、またはそれらに対する抗体、ペプチドホルモン、ステロイド、生理活性アミン類、ビタミン類、プロスタングランジン類、テトラサイクリン等の抗生物質、細菌等が産生する毒素、各種腫瘍マーカー、農薬、および当該病原微生物に由来する核酸成分に相補的なヌクレオチド等、臨床マーカー、食品中などのアレルギー物質などが挙げられる。 Examples of specimens that can be accommodated in the specimen test container of the present invention include wiping liquids such as nasal and throat swabs; excreta such as nasal discharge, sputum, stool, urine; blood; tissues; and cells. . Furthermore, examples of the analyte contained in the specimen are not necessarily limited, but include influenza virus, RS (Respiratory Synthetic) virus, adenovirus, group A streptococcus, pneumonia mycoplasma, Legionella, human metapneumovirus, norovirus, rotavirus. , Sapoviruses, pathogenic microorganisms such as diarrhea adenovirus, or substances such as proteins derived from the pathogenic microorganisms, or antibodies against them, peptide hormones, steroids, bioactive amines, vitamins, prostaglandins, tetracyclines, etc. Antibiotics, toxins produced by bacteria, various tumor markers, agricultural chemicals, nucleotides complementary to nucleic acid components derived from the pathogenic microorganisms, clinical markers, allergic substances in foods, etc. That.
　本発明の検体試験容器は、係止部材を使用することなくフィルタを確実に収容かつ固定することで、例えば、係止部材やフィルタの脱落あるいはフィルタのズレによって、使用時に検体試料液が濾過されることなく測定に使用されるリスクを一掃することができる検体試験容器である。 The sample test container according to the present invention securely stores and fixes the filter without using the locking member, so that the sample liquid is filtered at the time of use due to, for example, dropping of the locking member or filter or displacement of the filter. This is a sample test container that can wipe out the risks used for measurement without any problems.
（検体試験キット）
　本発明の検体試験キットは、上記検体試料液を収容するための容器と、該検体試料液に含まれる被測定物の特性をアッセイするためのテストプレートとを含む。 (Sample test kit)
The sample test kit of the present invention includes a container for storing the sample sample solution and a test plate for assaying the characteristics of the measurement object contained in the sample sample solution.
　本発明を構成するテストプレートは、例えば、捕捉物質および検出試薬を含有し、例えば、当該分野において公知のイムノクロマトグラフィー法のプレートであってもよい。 The test plate constituting the present invention contains, for example, a capture substance and a detection reagent, and may be, for example, an immunochromatography method plate known in the art.
　捕捉物質は、例えば、検体が細菌、ウイルス、ホルモン、またはその他の臨床マーカーである場合には、これらに対して特異的に反応し結合する抗体（例えば、ポリクローナル抗体およびモノクローナル抗体）が挙げられる。このような捕捉物質はテストプレートに設けられた所定のメンブレン表面に、当業者に公知の方法で固定化され得る。メンブレン上の捕捉物質の固定化は、例えば、捕捉物質を緩衝液等に希釈した溶液をメンブレンに吸着してその後乾燥することにより行われる。捕捉物質は、テストプレートにおいて、例えばライン状に固定化され得る。 Examples of the capture substance include antibodies (for example, polyclonal antibodies and monoclonal antibodies) that specifically react and bind to bacteria, viruses, hormones, or other clinical markers. Such a capturing substance can be immobilized on a predetermined membrane surface provided on the test plate by a method known to those skilled in the art. Immobilization of the capture substance on the membrane is performed, for example, by adsorbing a solution obtained by diluting the capture substance in a buffer or the like to the membrane and then drying it. The capture substance can be immobilized on the test plate, for example in a line.
　例えば、本発明の検体試験キットが、アデノウイルスやＲＳウイルスの病原体による罹患を診断するためのキットとして使用される場合、上記テストプレートには、捕捉物質として抗アデノウイルス抗体や抗ＲＳウイルス抗体が固定化されている。あるいは、例えば、本発明の検体試験キットが、臨床マーカーや食品中などのアレルギー物質を検出するための検出キットとして使用される場合、上記テストプレートには、捕捉物質として、該臨床マーカーや該アレルギー物質に対する抗体が固定化されている。１つのテストプレートに固定化することのできる抗体の種類は特に限定されず、１つまたは複数の抗体が固定化されてもよい。 For example, when the specimen test kit of the present invention is used as a kit for diagnosing morbidity caused by an adenovirus or RS virus pathogen, the test plate contains an anti-adenovirus antibody or an anti-RS virus antibody as a capture substance. It is fixed. Alternatively, for example, when the sample test kit of the present invention is used as a detection kit for detecting allergens such as clinical markers and foods, the test plate contains the clinical markers and allergies as capture substances. An antibody against the substance is immobilized. The type of antibody that can be immobilized on one test plate is not particularly limited, and one or more antibodies may be immobilized.
　検出試薬は、被測定物に特異的に結合し、被測定物との複合体を形成し得るものである。例えば、被測定物がウイルス等の抗原物質である場合には、検出試薬は、そのウイルスに対する抗体であって、標識化された抗体が挙げられる。標識化される前の抗体の例は、上記捕捉試薬について使用され得るものと同様である。標識化に用いられる物質の例としては、酵素、蛍光・化学発光性標識、磁性体標識、放射性同位元素、金コロイド、ビーズ、および着色ラテックスなどが挙げられる。 The detection reagent specifically binds to the object to be measured and can form a complex with the object to be measured. For example, when the object to be measured is an antigenic substance such as a virus, the detection reagent is an antibody against the virus and includes a labeled antibody. Examples of antibodies before labeling are similar to those that can be used for the capture reagent. Examples of substances used for labeling include enzymes, fluorescent / chemiluminescent labels, magnetic labels, radioisotopes, colloidal gold, beads, and colored latex.
　このような検出試薬は、当業者に周知の方法により予めテストプレートに組み込まれている。例えば、本発明の検体試験キットが、アデノウイルスやＲＳウイルスの罹患を診断するためのキットとして使用される場合、上記テストプレートには、検出試薬として金コロイド標識抗アデノウイルス抗体や金コロイド標識抗ＲＳウイルス抗体が組み込まれている。あるいは、例えば、本発明の検体試験キットが、臨床マーカーや食品中などのアレルギー物質を検出するための検出キットとして使用される場合、上記テストプレートには、検出試薬として、該臨床マーカーや該アレルギー物質に対する抗体が組み込まれている。一つのテストプレートに一つ或は複数の測定項目を設けるかどうかは限定されない。 Such a detection reagent is previously incorporated in a test plate by a method well known to those skilled in the art. For example, when the sample test kit of the present invention is used as a kit for diagnosing adenovirus or RS virus disease, the test plate contains a colloidal gold-labeled anti-adenovirus antibody or a colloidal gold-labeled anti-virus as a detection reagent. RS virus antibody is incorporated. Alternatively, for example, when the sample test kit of the present invention is used as a detection kit for detecting allergens such as clinical markers and foods, the test plate contains the clinical markers and allergies as detection reagents. An antibody against the substance is incorporated. It is not limited whether one or a plurality of measurement items are provided on one test plate.
　なお、本発明の検体試験キットにおいて、当該検出試薬は、テストプレートに予め組み込まれている代わりに、上記検体試験液が添加された後に、当該テストプレートに添加されるものであってもよい。 In the sample test kit of the present invention, the detection reagent may be added to the test plate after the sample test solution is added, instead of being incorporated in advance in the test plate.
　本発明の検体試験キットはまた、検体を採取するための採取用具を含んでいてもよい。このような採取用具の例としては、綿棒、採取用具、採取容器、ブラシなどが挙げられる。採取用具は滅菌されていることが好ましい。本発明の検体試験キットはまた、必要に応じて、例えば酵素と基質との反応を停止させるための反応停止液が含まれていてもよい。このような反応停止液としては、例えば、クエン酸、硫酸等が挙げられる。さらに本発明の検体試験キットは、必要に応じて取扱・使用説明書等が含まれていてもよい。 The sample test kit of the present invention may also include a collection tool for collecting a sample. Examples of such collection tools include cotton swabs, collection tools, collection containers, brushes and the like. The collection tool is preferably sterilized. The sample test kit of the present invention may also contain a reaction stop solution for stopping the reaction between the enzyme and the substrate, for example, as necessary. Examples of such a reaction stop solution include citric acid and sulfuric acid. Furthermore, the sample test kit of the present invention may include instructions for handling and use as necessary.
　次に、本発明の検体試験キットの使用方法の一例であって、当該キットがインフルエンザキットである場合であって、鼻腔拭い液を検体とする場合の使用方法の例について説明する。 Next, an example of a method for using the sample test kit of the present invention, which is a case where the kit is an influenza kit and a nasal wipe is used as a sample, will be described.
　まず、図８の（ａ）に示すように、例えば、被験者の鼻腔を所定の様式で拭った綿棒４１０（採取用具）が、緩衝液４１２を含有する容器基部１２０内に浸漬される。その後、綿棒４１０は、例えば、１０回以上緩衝液中で上下に動かして、最終的に扱く様にして引き抜かれる。このようにして容器基部１２０内に検体試料液が調製される。次いで、図８の（ｂ）に示すように、容器基部１２０内に検体試料液４２０が入ったままの状態で容器基部１２０とノズルキャップ１４０とがしっかりと螺合される。そして、図８の（ｃ）に示すように、容器基部１２０が両側から押されて、検体試験容器１００の滴下口１４２から、フィルタ（図示せず）で濾過された検体試料液４２２の所定量（例えば、３滴）が、テストプレート４３０の滴下部４３２に滴下される。その後、テストプレート４３０はそのまま水平の状態で静置され、所定時間の経過後、テストプレート４３０の表示窓４３４が医師らにより目視判定される。表示窓４３４に表示される所定のラインを通じ、医師らは、各種インフルエンザウイルスに対する陽性または陰性等（例えば、インフルエンザＡウイルス抗原に対して陽性、インフルエンザＢウイルス抗原に対して陽性、インフルエンザＡウイルス抗原およびインフルエンザＢウイルス抗原のいずれに対しても陽性、インフルエンザＡウイルス抗原およびインフルエンザＢウイルス抗原のいずれに対しても対して陰性、あるいは適切な表示がなされず再試験）の判定を行うことができる。 First, as shown in FIG. 8A, for example, a cotton swab 410 (collecting tool) obtained by wiping the subject's nasal cavity in a predetermined manner is immersed in the container base 120 containing the buffer 412. Thereafter, the cotton swab 410 is pulled up and down, for example, by moving it up and down in the buffer solution 10 times or more and finally handling it. In this way, the specimen sample solution is prepared in the container base 120. Next, as shown in FIG. 8B, the container base 120 and the nozzle cap 140 are firmly screwed together while the specimen sample solution 420 remains in the container base 120. Then, as shown in FIG. 8C, a predetermined amount of the sample liquid 422 filtered by a filter (not shown) from the dropping port 142 of the sample test container 100 when the container base 120 is pushed from both sides. (For example, 3 drops) is dropped on the dropping part 432 of the test plate 430. Thereafter, the test plate 430 is left in a horizontal state as it is, and after a predetermined time has elapsed, the display window 434 of the test plate 430 is visually determined by doctors. Through a predetermined line displayed on the display window 434, doctors and the like are positive or negative for various influenza viruses (eg, positive for influenza A virus antigen, positive for influenza B virus antigen, influenza A virus antigen and It is possible to make a positive determination for any of the influenza B virus antigens, a negative for any of the influenza A virus antigens and the influenza B virus antigens, or a retest without proper display.
　本発明によれば、例えば、アッセイの感度および性能を低下させることなく、迅速かつ効率的な簡易検査が要求される医療分野において有用である。 The present invention is useful, for example, in the medical field where a quick and efficient simple test is required without degrading the sensitivity and performance of the assay.
　１００　　　　　検体試験容器
　１２０　　　　　容器基部
　１４０，２４０　ノズルキャップ
　１４１　　　　　ノズル本体
　１４２，２４２　滴下口
　１４３，２４３　ノズル管
　１４４　　　　　キャップ部分
　１４６，２４６　フィルタ収容部
　１４７，２４７　開放端
　１４８，２４８　基端部
　１４９，２４９　リップ
　１５０　　　　　フィルタ
　２５２　　　　　溝
　４１０　　　　　綿棒
　４１２　　　　　緩衝液
　４２０　　　　　検体試料液
　４２２　　　　　濾過された検体試料液
　４３０　　　　　テストプレート
　４３２　　　　　滴下部
　４３４　　　　　表示窓 DESCRIPTION OF SYMBOLS 100 Sample test container 120 Container base 140,240 Nozzle cap 141 Nozzle main body 142,242 Drop port 143,243 Nozzle pipe 144 Cap part 146,246 Filter accommodating part 147,247 Open end 148,248 Base end part 149,249 Lip 150 Filter 252 Groove 410 Cotton swab 412 Buffer 420 Specimen sample solution 422 Filtered sample sample solution 430 Test plate 432 Drip section 434 Display window

Claims (8)

  1. 　容器基部の開放端と接続して検体試験容器を構成し得る、ノズルキャップであって、
    　該容器基部の開放端と接続可能なキャップ部分と検体試料液を滴下口から排出するためのノズル管とを備える、ノズル本体；および
    　該ノズル本体内に収容されたフィルタ；
    　を備え、
    　ここで、
    　該ノズル本体が、該キャップ部分の内部に筒状のフィルタ収容部を有し、そして
    　該フィルタが、該フィルタ収容部の該開放端に設けられた複数のリップの折畳みによって該フィルタ収容部内に収容かつ係止されている、ノズルキャップ。     A nozzle cap that can be connected to the open end of the container base to form a specimen test container,
    A nozzle body comprising a cap portion connectable to the open end of the container base and a nozzle tube for discharging the sample liquid from the dropping port; and a filter accommodated in the nozzle body;
    With
    here,
    The nozzle body has a cylindrical filter housing portion inside the cap portion, and the filter is housed in the filter housing portion by folding a plurality of lips provided at the open end of the filter housing portion. And the nozzle cap is locked.
  2. 　前記複数のリップが、前記フィルタ収容部の前記開放端上で略等間隔となるように設けられている、請求項１に記載のノズルキャップ。 The nozzle cap according to claim 1, wherein the plurality of lips are provided at substantially equal intervals on the open end of the filter housing portion.
  3. 　前記複数のリップの数が２個から１６個である、請求項１または２に記載のノズルキャップ。 The nozzle cap according to claim 1 or 2, wherein the number of the plurality of lips is 2 to 16.
  4. 　前記ノズル本体が熱可塑性樹脂で構成されている、請求項１から３のいずれかに記載のノズルキャップ。 The nozzle cap according to any one of claims 1 to 3, wherein the nozzle body is made of a thermoplastic resin.
  5. 　前記複数のリップの折畳みによる前記フィルタの係止が超音波処理により行われている、請求項４に記載のノズルキャップ。 The nozzle cap according to claim 4, wherein the filter is locked by ultrasonic treatment by folding the plurality of lips.
  6. 　検体試験を行うための検体試料液を収容するための容器であって、
    　請求項１から５のいずれかに記載のノズルキャップ；および
    　検体試料液を収容するための容器基部；
    を備える、容器。     A container for storing a sample liquid for performing a sample test,
    A nozzle cap according to any one of claims 1 to 5; and a container base for containing a specimen sample solution;
    A container.
  7. 　請求項６に記載の検体試料液を収容するための容器と、
    　該検体試料液に含まれる被測定物の特性をアッセイするためのテストプレートと、
    を含む、検体試験キット。     A container for containing the sample liquid according to claim 6;
    A test plate for assaying the characteristics of an object to be measured contained in the sample liquid;
    A specimen test kit comprising:
  8. 　さらに検体を採取するための採取用具を含む、請求項７に記載のキット。 The kit according to claim 7, further comprising a collection tool for collecting a sample.
PCT/JP2015/074170 2014-08-28 2015-08-27 Nozzle cap for specimen test container, and specimen test container and specimen test kit using same WO2016031899A1 (en)

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