WO2012000734A1 - Kit de test - Google Patents

Kit de test Download PDF

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Publication number
WO2012000734A1
WO2012000734A1 PCT/EP2011/058990 EP2011058990W WO2012000734A1 WO 2012000734 A1 WO2012000734 A1 WO 2012000734A1 EP 2011058990 W EP2011058990 W EP 2011058990W WO 2012000734 A1 WO2012000734 A1 WO 2012000734A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
specimen
inner chamber
bottom portion
test kit
Prior art date
Application number
PCT/EP2011/058990
Other languages
English (en)
Inventor
Matsuura Shinji
Original Assignee
Copan Italia S.P.A.
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 Copan Italia S.P.A. filed Critical Copan Italia S.P.A.
Publication of WO2012000734A1 publication Critical patent/WO2012000734A1/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0689—Sealing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0848—Specific forms of parts of containers
    • B01L2300/0851—Bottom walls
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber

Definitions

  • the present invention relates to a test kit and, more particularly, to a test kit used when a test sample prepared by processing a specimen collected from a patient's body such as his pharynx using two kinds of pharmaceutical agents is tested to test, for example, whether antigens of Group A Streptococcus are present in the specimen.
  • a specimen collected froma patient ' s body such as his pharynx (for example, specimen attached to a cotton ball of a cotton swab used as a specimen collector) is dipped in a mixture obtained by mixing a first pharmaceutical agent (for example, 2 mol/L of sodium nitrite) with a second pharmaceutical agent (for example, 0.3 mol/L of acetic acid) , and a resulting test sample, which is the mixture further including an adequate amount of the specimen transferred thereto (specimen extract) , is tested to test the presence of antigens of Group A Streptococcus in the specimen.
  • a first pharmaceutical agent for example, 2 mol/L of sodium nitrite
  • a second pharmaceutical agent for example, 0.3 mol/L of acetic acid
  • a test kit used in a test where mixing of the first and second pharmaceutical agents is thus required includes a first container for housing the first pharmaceutical agent therein, a second container for housing the second pharmaceutical agent therein, a specimen collecting tool for collecting the specimen, and a processing container used to mix the first pharmaceutical agent with the second pharmaceutical agent and also dip the specimen collecting tool which collected the specimen in the resulting mixture to transfer the specimen thereto.
  • test kit To use the test kit, it is necessary to prepare the first and second containers separately and further the processing container.
  • the test kit needs to be equipped with at least four structural elements separately, including the specimen collectingtool, andit is awkwardto store sucha test kit somewhat bulky.
  • another example of the test kit which requires mixing of the first and second pharmaceutical agents includes: a first container (chamber) 61 made of resin for housing a first pharmaceutical agent 51 therein; a second container (inner chamber) 62 made of resin for housing a second pharmaceutical agent 52 therein, the second container 62 being inserted in the first container 61 through an opening 61a of the first container 61 to seal the opening 61a of the first container 61; a sealingmember 63 provided to seal an opening 62a of the second container 62 inserted in the first container 61 to seal the opening 61a, the sealing member 63 further holding the second container 62 engaged with the opening 61a of the first container 61 to seal the opening 61a of the first container 61; and a specimen collecting tool, for example, a cotton swab (not illustrated in the drawings) having a specimen collector which collects and retains a specimen such as a cotton ball at a first end thereof.
  • a specimen collecting tool for example, a cotton swab (not
  • a flange portion 61b is provided in the peripheral portion of the opening 61a of the first container 61
  • a flange portion 62b is provided in the peripheral portion of the opening 62a of the second container 62.
  • the sealing member 63 used in the test kit is an aluminum foil having a resin film which joins the respective elements.
  • the aluminum foil (sealingmember) 63 is bonded to the opening 61a of the first container 61, opening 62a of the second container
  • first container 61 and the second container 62 are held as a unit with the first and second pharmaceutical agents 51 and 52 enclosed therein.
  • the specimen collector (for example, cotton ball) of the specimen collecting tool for example, cotton swab
  • the specimen collector (cotton ball) to which the specimen is attached arrives in the first container 61
  • the second pharmaceutical gent 52 of the second container 62 is guided into the first container 61 to be mixed with the first pharmaceutical agent 51 of the first container 61
  • the specimen collector of the specimen collecting tool to which the specimen is attached is dipped in the resulting mixture including the first and second pharmaceutical agents so that the specimen is transferred to the mixture.
  • the test sample which is the mixture including the first and second pharmaceutical agents further including the specimen transferred thereto, is obtained in the first container 61.
  • the test kit however, has some problems.
  • the specimen collecting tool (cotton swab) is pushed into the second container 62 to break through the bottom portion thereof.
  • the bottom portion may be too stretchy depending on a material of the second container 62, and the specimen collecting tool (cotton swab) , though pushed hard all the way in, possibly fails to penetrate through (break through) the bottom portion, or the bottom portion may be too thick for the specimen collecting tool to break therethrough unless a very large force is applied thereto.
  • these possible disadvantages of the test kit may deteriorate workability.
  • the first container of the test kit cannot be sealed after the aluminum foil, which is the sealing member 63, is removed to transfer the specimen to the mixture. Therefore, it is practically infeasible to transport the test sample to the laboratory.
  • An object of the present invention is to provide a test kit that can be used to test a test sample prepared by processing a specimen collected from a patient's body such as his pharynx using two kinds of pharmaceutical agents to test, for example, whether antigens of Group A Streptococcus are present in the specimen .
  • the test kit provided by the present invention is compact, capable of readily and reliably preparing the test sample and safely transporting the prepared test sample to a laboratory, and improved in user-friendliness.
  • test kit according to the present invention includes:
  • a sealing member for sealing the opening of the inner chamber and making the flange portion of the inner chamber abut the opening at the first end of the chamber to seal the opening of the chamber;
  • a specimen collecting tool including a specimen collector for collecting and retaining a specimen in at least one end of a member thereof having a shape of a shaft, wherein the specimen collector of the specimen collecting tool to which the collected specimen is attached is inserted into the inner chamber through the opening so that the specimen collector penetrates through the bottom portion of the inner chamber to be seated in the chamber, the second pharmaceutical agent inside the inner chamber is guided into the chamber to be mixed with the first pharmaceutical agent in the chamber, the specimen collector to which the specimen is attached is dipped in a resulting mixture including the first and second pharmaceutical agents so that the specimen is transferred into the mixture, and the specimen collecting tool as well as the inner chamber is thereafter removed from the chamber so that a test sample, which is a mixture including the first and second pharmaceutical agents and further including the specimen transferred thereto, is obtained in the chamber,
  • an inner surface on the bottom portion of the inner chamber is gradually raised upward from a peripheral portion toward a central portion thereof
  • an annular groove formed circumferentially along the bottom portion of the inner chamber is formed in a peripheral portion of an outer surface on the bottom portion of the inner chamber, a thin film portion constituting a bottom portion of the groove connects the bottom portion of the inner chamber with other portions, a predetermined location in the peripheral portion of the bottom portion of the inner chamber is pressed by the specimen collecting tool, side surfaces facing each other constituting the groove abut each other at a predetermined circumferential position of the bottom portion when the thin film portion stretches at the pressed location and a vicinity thereof, making the bottom portion tilted, and the thin film portion is restricted from stretching near the abuttingposition, and when the predetermined position is pressed by the specimen collecting tool, the thin film portion further stretches at a position where the stretch is not restricted to finally break so that the specimen collecting tool penetrates through the bottom portion of the inner chamber.
  • the test kit according to the present invention is configured such that the annular groove formed circumferentially along the bottom portion of the inner chamber is formed in the peripheral portion of the outer surface on the bottom portion of the inner chamber, the thin film portion constituting the bottomportion of the groove connects the bottom portion of the inner chamber with the other portions of the inner chamber, the predetermined location in the peripheral portion of the bottom portion of the inner chamber is pressed by the specimen colleting tool, side surfaces facing each other constituting the groove abut each other at a predetermined circumferential position of the bottom portion when the thin film portion stretches at the pressed location and a vicinity thereof, making the bottom portion tilted, and the thin film portion is restricted from stretchingnear the abutting position, and when the predetermined position is pressed by the specimen collecting tool, the thin film portion further stretches at a position where the stretch is not restricted to finally break so that the specimen collecting tool penetrates through the bottom portion of the inner chamber .
  • the specimen collecting tool which already collected the specimen can readily and reliablybreak through the bottomportion of the inner chamber .
  • the first and second pharmaceutical agents are mixed after the specimen is collected, and the specimen is transferred to the resulting mixture.
  • the present invention can provide the test kit improved in user-friendliness and capable of readily and reliably preparing the test sample by processing the specimen using two kinds of pharmaceutical agents.
  • the first and second pharmaceutical agents are usually pharmaceutical agents in a form of liquid. As disclosed in the invention of claim 4, however, the first pharmaceutical agent may be a pharmaceutical agent in a form of powder, which will be described later.
  • the test kit according to claim 2 further includes a drip chip for dripping the test sample into the chamber so that the test sample is tested, wherein the drip chip is attached to the opening of the chamber after the specimen collecting tool and the inner chamber are removed from the chamber.
  • the test sample in the chamber which is themixture further includingthe specimentransferredthereto, can be readily and reliably tested after the specimen collecting tool and the inner chamber are removed from the chamber. This configuration can realize the effect of the present invention.
  • the specimen collecting tool is a cotton swab having a cotton ball serving as the specimen collector in the at least one end thereof.
  • the specimen collecting tool is the cotton swab having the cotton ball serving as the specimen collector in the at least one end thereof, it is possible to provide a test kit that can collect the specimen without a specially designed tool . Further, when the specimen collecting tool (cotton swab) is pulled out after penetrating through the bottom portion with the cotton ball left caught in the through hole formed in the bottom portion, the specimen collecting tool and the inner chamber can be easily removed from the chamber. This configuration can further realize the effect of the present invention .
  • the first pharmaceutical agent housed in the chamber is a pharmaceutical agent in a form of powder
  • the second pharmaceutical agent housed in the inner chamber is a pharmaceutical agent in a form of liquid.
  • the test kit according to the present invention is configured such that the specimen collecting tool which already collected the specimen penetrates through the bottom portion of the inner chamber. Therefore, the test kit according to the present invention is obviously applicable to the case where the first and second pharmaceutical agents are in the form of liquid, and is also applicable to the case where the first pharmaceutical agent housed in the chamber is the pharmaceutical agent in the form of powder, and the case where the second pharmaceutical agent housed in the inner chamber is the pharmaceutical agent in the form of liquid as recited in claim 4.
  • the pharmaceutical agent in the form of liquid housed in the inner chamber flows downward therefrom to be mixed with the first pharmaceutical agent. Then, the first pharmaceutical agent is dissolved in the pharmaceutical agent in the form of liquid so that the mixture can be prepared.
  • the second pharmaceutical agent in the form of powder may dwell in the inner chamber, failing to fall downward into the chamber even after the bottomportion of the inner chamber is broken. Therefore, the second pharmaceutical agent to be housed in the inner chamber is preferably a pharmaceutical agent in the form of liquid.
  • the sealing member is a threaded cap in an inner peripheral surface thereof, the thread of the cap being engaged with a thread formed in an outer peripheral portion of the chamber, and an inner upper surface of the cap abuts the opening of the inner chamber to seal the inner chamber, the flange portion of the inner chamber abuts the opening of the chamber to seal the chamber by using the inner chamber, and the inner upper surface abuts the opening of the chamber to seal the chamber after the inner chamber is removed from the chamber.
  • the chamber and the inner chamber can be both sealed without fail with the pharmaceutical agents enclosed therein before the test, and the chamber housing therein the test sample prepared by transferring the collected specimen to the mixture (chamber after the inner chamber and the specimen collecting tool are already removed therefrom) can also be surely sealed. Then, the prepared test sample can be safely and reliably transported to, for example, a laboratory.
  • This configuration can further realize the effect of the present invention.
  • a region circumferentially along an inner peripheral surface of the chamber and a region circumferentially along an outer peripheral surface of the inner chamber abut each other at a position closer to the bottomportion of the inner chamber than an axially central portion thereof to seal the chamber.
  • the sealing effect by the sealing member is enhanced by the sealing effect by the abutting portions of the inner peripheral surface of the chamber and the outer peripheral surface of the inner chamber.
  • This sealing effect thus further ensured can prevent such an undesirable event that the pharmaceutical agent in the chamber (first pharmaceutical agent) may leak out near the opening of the chamber when the sealing member is removed during use.
  • the test kit can be a more reliable device.
  • the test kit according to claim 7 further includes a filter for filtering and removing solid matter in a passageway of the drip chip where the test sample travels.
  • test kit In the test kit according to claim 8, the test kit is used in a test for hemolytic streptococcal infection.
  • test kit according to the present invention When the test kit according to the present invention is used, a test for hemolytic streptococcal infection in which it is necessary to test a test sample prepared by processing a specimen using two kinds of pharmaceutical agents can be tested efficiently and without fail.
  • Fig. 1 is an exploded view illustrating the configuration of a test kit (sectional views of main structural elements) according to an embodiment of the present invention
  • Fig. 2 is a sectional view of an assembled unit including a chamber in which a first pharmaceutical agent is housed, an inner chamber in which a second pharmaceutical agent is housed, and a sealing member, which are structural elements of the test kit according to the embodiment of the present invention;
  • Fig. 3 is an enlarged view of a main section of the test kit according to the embodiment of the present invention, illustrating a method of using the test kit, wherein a specimen collecting tool abuts a bottom portion of the inner chamber;
  • Fig. 4 is an enlarged view of a main section of the test kit according to the embodiment of the present invention, illustrating the method of using the test kit, wherein the specimen collecting tool is pressed onto the bottom portion of the inner chamber to penetrate through the bottom portion of the inner chamber;
  • Fig.5 is a view of themethod of using the test kit according to the embodiment of the present invention, wherein a specimen collector of the specimen collecting tool is dipped in a mixture of pharmaceutical agents in the chamber;
  • Fig.6 is a view of a method of using the test kit according to the embodiment of the present invention, wherein a test sample prepared by transferring the specimen to the mixture is supplied to a test by way of a drip chip;
  • Fig. 7 is an exploded view of a conventional test kit.
  • Fig. 8 is a sectional view of an assembled unit including a first container (chamber) and a second container (inner chamber) constituting the conventional test kit.
  • a test sample prepared by processing a specimen using two kinds of pharmaceutical agents is tested.
  • the description is given below referring to a test kit used to test whether antigens of Group A Streptococcus are present.
  • test kit used in Embodiment 1 includes:
  • an inner chamber 2 made of resin for housing a second pharmaceutical agent 12 therein (Fig. 2), the inner chamber 2 being a cylindrical member having an opening 2a at a first end thereof and a second end which is sealed by a bottom portion 20 and provided with a flange portion 2b around the opening 2a, and the inner chamber 2 being inserted in the chamber 1 with the second end thereof first through the opening la of the chamber 1 to seal the opening la of the chamber 1, and the flange portion 2b in the first end abutting the opening la at the first end of the chamber 1 to be held at the abutting portion;
  • a sealing member 3 for sealing the opening 2a of the inner chamber 2 and making the flange portion 2b of the inner chamber 2 abut the opening la at the first end of the chamber 1 to seal the opening la of the chamber 1;
  • a specimen collecting tool 4 including a specimen collector 4b for collecting and retaining a specimen in at least one end of a shaft-like member 4a;
  • a drip chip 5 for dripping a test sample S obtained by transferring the specimen to a mixture of the first and second pharmaceutical agents 11 and 12 (Fig. 5) from the chamber 1 so that the test sample S can be tested.
  • An example of the first pharmaceutical agent is 2 mol/L of sodium nitrite, and an example of the second pharmaceutical agent is 0.3 mol/L of acetic acid.
  • the shaft-like member 4a made of resin such as polystylene is provided with on one end thereof a cotton ball serving as the specimen collector 4b for collecting and retaining the specimen, a generally called cotton swab.
  • synthetic fiber is flock-finished so that the specimen can be collected and retained well.
  • the specimen collecting tool 4 is not necessarily limited to the cotton swab, and the cotton swab may have a brush on one end thereof. Any other specimen collecting tools can be used as far as the specimen can be thereby collected and retained.
  • All of the structural elements but the specimen collecting tool 4 in the test kit used in the embodiment are transparent or semi-transparent and made of materials having plasticity (low-density polyethylene in the embodiment) .
  • plasticity low-density polyethylene in the embodiment
  • what materials are used to form the structural elements of the test kit according to the present invention is not particularly limited, and various materials are usable unless the operational effect of the present invention is not undermined.
  • An inner surface on the bottom portion of the inner chamber 2 is gradually raised upward from its periphery toward center.
  • annular groove 21 is formed circumferentially along the bottom portion 20.
  • the bottom portion 20 of the inner chamber 2 is connected to the other portions of the inner chamber 2 with a thin film portion 23 constituting a bottom (groove bottom) 22 of the groove 21.
  • the groove 21 formed circumferentially along thebottomportion 20 includes side walls 21a and 21b facing each other, and the groove bottom portion
  • the groove 21 is formed with an angle of a small degree in its depth direction relative to an axial direction of the inner chamber 2, and the side walls 21a and 21b facing each other are formed with a predefined angle so that an interval therebetween is smaller toward the groove bottom portion 22.
  • the structural characteristic of the groove 21 is not particularly limited, and the groove 21 can be structurally modified to meet the needs as far as the object of the present invention can be accomplished.
  • the specimen collector 4b of the specimen collecting tool 4 to which the specimen is attached is inserted in the inner chamber 2 through the opening 2a to penetrate through the bottom portion 20 so that the specimen collector 4b of the specimen collecting tool 4 to which the specimen is attached can arrive in the chamber 1.
  • the second pharmaceutical agent 12 in the inner chamber 2 is guided into the chamber 1 to be mixed with the first pharmaceutical agent 11 in the chamber 1, and the specimen collector 4b to which the specimen is attached is dipped in the mixture 13 of the first and second pharmaceutical agents 11 and 12 so that the specimen is transferred to the mixture 13.
  • the test sample S is prepared.
  • the specimen collecting tool 4 is removed from the chamber 1 as well as the inner chamber 2.
  • the test samples which is the mixture 13 (Fig.5) including the specimen transferred thereto, is obtained in the chamber 1.
  • the sealingmember 3 is a threaded cap in an innerperipheral surface thereof, the thread 3a of the cap being engaged with a thread lb formed in an outer peripheral portion of the chamber 1, and an inner upper surface 3b of the cap abuts the opening 2a of the inner chamber 2 (first end of the inner chamber 2) to seal the inner chamber 2, the flange portion 2b of the inner chamber 2 abuts the opening la of the chamber 1 (stepwise portion on the first end of the chamber l)to seal the chamber 1 by using the inner chamber 2, and the inner upper surface 3b abuts the opening la of the chamber 1 to seal the chamber 1 after the inner chamber 2 is removed from the chamber 1.
  • a projected portion 2c is formed on an end surface of the inner chamber 2 to ensure close contact with the inner upper surface 3b of the sealing member (cap) 3 so that the sealing effect can be reliably exerted.
  • a proj ected portion may be formed on one end surface of the chamber 1 where the opening la is provided so that the chamber 1 is more reliably sealed.
  • a small projected portion lc is formed along an inner circumference of the chamber 1 at a position closer to the bottom portion than the axial center of the inner chamber 2 as illustrated in Fig. 2.
  • the inner peripheral surface of the chamber 1 and the outer peripheral surface of the inner chamber 2 unfailingly abut each other so that the chamber 1 can be sealed well by the abutting portion.
  • the projected portion is not the only option of the additional structural element which helps the inner peripheral surface of the chamber 1 and the outer peripheral surface of the inner chamber 2 unfailingly abut each other at a position closer to the bottom portion than the axial center of the inner chamber 2.
  • a projected portion may be formed on the outer peripheral surface of the inner chamber 2 in a manner opposite to the embodiment.
  • a shallow recessed groove may be formed along the outer peripheral surface of the inner chamber 2 as well as the proj ected portion formed on the inner peripheral surface of the chamber 1.
  • the shallow recessed groove is formed at a predefined position on the outer peripheral surface of the inner chamber 2 so as to fit into the projected portion lc.
  • the additional structural element can have any structure as far as it helps the inner peripheral surface of the chamber 1 and the outerperipheral surface of the inner chamber 2 closely fit into each other.
  • the drip chip 5 is used to drip the test sample S from the chamber 1 so that the test sample S, which is the mixture 13 of the first and second pharmaceutical agents 11 and 12 and further including the specimen transferred thereto, can be tested.
  • the drip chip 5 is fitted in the opening la of the chamber 1 which is uncovered with the sealing member 3 as illustrated in Fig. 6, and a liquid passageway 5a through which the test sample S travels is provided inside thereof.
  • the drip chip 5 may include a filter in a part of the liquid passageway 5a.
  • a filter in a part of the liquid passageway 5a.
  • a specimen is collected from a patient's body such as his pharynx by using the specimen collecting tool 4.
  • the specimen collector 4a on one end of the specimen collecting tool 4 is pushed against a predefined position on the bottom portion 20 in the inner chamber 2.
  • the inner surface on the bottom portion 20 of the inner chamber 2 is gradually raised upward from its periphery toward center . Therefore, the specimen collector 4b of the specimen collecting tool 4 abuts a given position of the peripheral portion in the bottom portion 20 of the inner chamber 2 which is lower than the center portion and pushes the given position.
  • the thin film portion 23 When the bottom portion 20 is thereafter continuously pressed by the specimen collecting tool 4, the thin film portion 23 further stretches at a position Q where the stretch of the thin film portion 23 is not restricted (more distant from the position P, the stretch of the thin film portion 23 is less restricted). The stretched thin filmportion 23 finally breaks, and the specimen collector 4a of the specimen collecting tool 4 penetrates through the bottom portion 20 of the inner chamber 2 to reach the chamber 1. As a result, the second pharmaceutical agent 12 of the inner chamber 2 flows downward into the chamber 1 through the broken bottom portion 20 of the inner chamber 2 and mixed with the first pharmaceutical agent of the chamber 1, and the mixture 13 is obtained.
  • the specimen collector 4 to which the specimen is attached is dipped in the mixture 13 in the chamber 1 so that the specimen is transferred to the mixture 13.
  • the specimen collecting tool 4 is pulled out from the chamber 1 along with the inner chamber 2. Then, the test sample S, which is the mixture 13 including the specimen transferred thereto, is obtained in the chamber 1.
  • the specimen collector (cotton ball) 4b provided on one end of the specimen collecting tool 4 is caught in the broken portion of the inner chamber 2, which is the periphery of the through hole or a part of the bottom portion 20 still connected to the body of the inner chamber 2. Therefore, the inner chamber 2 is usually easily removed from the chamber 1 as well as the specimen collecting tool 4 when the specimen collecting tool 4 is simply pulled out.
  • the drip chip 5 is mounted on the opening la of the chamber 1, and the opening la of the chamber 1 with the drip chip 5 mounted thereon is directed downward so that the test sample S is dripped by way of the drip chip 5 to be tested.
  • test sample can be efficiently tested to test whether antigens of Group A Streptococcus are present in the specimen .
  • test sample S is tested immediately after the inner chamber 2 and the specimen collecting tool 4 are removed from the chamber 1 in the processing step of 4) .
  • the test sample S may be transported to a laboratory to be tested there, in which case the test sample can be safely transported to the laboratory by sealing the chamber 1 using the sealing member 3 mounted on the opening la thereof.
  • the embodiment described so far employs the test kit used to test whether antigens of Group A Streptococcus are present in the specimen, wherein the liquid pharmaceutical agents as the first and second pharmaceutical agents are used (first pharmaceutical agent: 2 mol/L of sodium nitrite, second pharmaceutical agent: 0.3 mol/L of acetic acid).
  • first pharmaceutical agent 2 mol/L of sodium nitrite
  • second pharmaceutical agent 0.3 mol/L of acetic acid
  • a solid pharmaceutical agent in the form of powder or granule as the first pharmaceutical agent
  • a liquid pharmaceutical agent as the second pharmaceutical agent.
  • the specimen collecting tool penetrates through the bottom portion of the inner chamber to guide the second pharmaceutical agent in the form of liquid into the chamber so that the first pharmaceutical agent (solid pharmaceutical agent) is dissolved in the second pharmaceutical agent (liquid pharmaceutical agent) .
  • the test kit according to the present invention may use a solid pharmaceutical agent other than the liquid pharmaceutical agent as the first pharmaceutical agent housed in the chamber, thereby improving the degree of freedom in the range of applications.
  • the present invention is not necessarily limited to the embodiment in any other aspect.
  • the specific structures of the chamber, inner chamber, specimen collecting tool, and drip chip, and the specific structure of the groove which facilitates the break of the bottom portion of the inner chamber can be variously modified within the intended scope of the present invention.

Abstract

La présente invention concerne un kit de test, qui peut être utilisé pour tester un échantillon test préparé par traitement d'un prélèvement au moyen de deux types d'agents pharmaceutiques. Le kit de test est compact, permet de préparer facilement et de manière fiable l'échantillon test, et est amélioré du point de vue de sa praticité. Le kit de test comprend une chambre (1), une chambre interne (2), un élément d'étanchéité (3) et un instrument (4) de récupération de prélèvement. Une rainure annulaire (21) est formée dans une partie périphérique d'une surface externe, sur une partie inférieure (20) d'une chambre interne (2); et une partie de film mince (23) constituant des surfaces latérales (21a) et (21b) en regard, formant la rainure (22), relie la partie inférieure (20) aux autres parties de la chambre interne (2). Un instrument (4) de récupération de prélèvement exerce une pression à une position prédéfinie Q dans la partie périphérique de la partie inférieure, étirant la partie de film mince. Lorsque la partie de film mince s'étire ainsi, se juxtaposant à la partie inférieure, les surfaces latérales (21a) et (21b) formant la rainure (21) viennent en butée l'une contre l'autre, à une position prédéfinie P dans la direction périphérique de la partie inférieure, et l'extension de la partie de film mince (23) se trouve restreinte à proximité. Lorsque la force de pression est de nouveau appliquée à la position prédéfinie Q par l'instrument de récupération de prélèvement, la partie de film mince (23) s'étire de nouveau à proximité de la position Q pour finalement se rompre, et l'instrument de récupération de prélèvement pénètre à travers la partie inférieure de la chambre interne.
PCT/EP2011/058990 2010-05-31 2011-05-31 Kit de test WO2012000734A1 (fr)

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JP2010124230A JP4961029B2 (ja) 2010-05-31 2010-05-31 検査用キット
JP2010-124230 2010-05-31

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018025046A3 (fr) * 2016-08-05 2018-05-11 Nn Scientific Limited Dispositif
CN110271750A (zh) * 2019-07-24 2019-09-24 苏州天茹生物科技有限公司 一种用于生物医疗用样品存放盒
EP3431953A4 (fr) * 2016-03-15 2019-09-25 Sekisui Medical Co., Ltd. Récipient de test et procédé de test l'utilisant
CN113109582A (zh) * 2021-04-08 2021-07-13 埃妥生物科技(杭州)有限公司 一种样本提取器以及样本的提取方法
US11255756B2 (en) 2016-03-15 2022-02-22 Sekisui Medical Co., Ltd. Testing vessel and testing method employing same
US11291986B2 (en) 2017-02-24 2022-04-05 Becton, Dickinson And Company Unique sample transfer device for an automated pipettor for processing a variety of clinical microbiological specimens
CN116430042A (zh) * 2023-04-14 2023-07-14 河南师范大学 一种简易鼻咽拭子抗原检测装置及检测方法

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6268906B2 (ja) * 2013-10-17 2018-01-31 Ｄｉｃプラスチック株式会社 混合容器、及び、混合容器の製造方法
WO2017168876A1 (fr) * 2016-03-31 2017-10-05 Ｎｅｃソリューションイノベータ株式会社 Récipient d'analyse, instrument d'analyse de cible l'utilisant et procédé d'analyse de cible
KR102326723B1 (ko) * 2021-01-20 2021-11-16 (주)바이온라이프사이언스 검체 채취용 키트
KR102629716B1 (ko) * 2021-05-10 2024-01-29 바디텍메드(주) 채취 수단이 장착된 판독 장비에 사용되는 바이오 샘플을 채취하는 키트

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005071388A1 (fr) * 2004-01-21 2005-08-04 Orion Diagnostica Oy Dispositif d'echantillonnage et de dosage
EP1867972A1 (fr) * 2005-03-14 2007-12-19 Nipro Corporation Récipient d échantillonnage de liquide
WO2008038653A1 (fr) * 2006-09-27 2008-04-03 Shin Corporation procédé de traitement d'échantillon et trousse d'essai
EP1909089A1 (fr) * 2005-06-08 2008-04-09 Nipro Corporation Recipient pour prelevement d' echantillons en phase liquide
US20080251489A1 (en) * 2007-04-16 2008-10-16 Becton, Dickinson And Company Pierceable cap
EP1994986A1 (fr) * 2007-05-15 2008-11-26 ABS Advanced Biomedical Systems Srl Procédé et dispositif d'extraction antigène rapide
WO2009075637A1 (fr) * 2007-12-10 2009-06-18 Astrazeneca Ab Bouchon de flacon

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000346838A (ja) * 1999-03-30 2000-12-15 Kikkoman Corp 検体検査用器具及び拭取検査用器具
EP1355710A4 (fr) * 2001-01-05 2005-01-26 Pro Chem Inc Dispositifs et procedes de purification
JP3642574B2 (ja) * 2002-04-22 2005-04-27 北斗科学産業株式会社 遺伝子検出用具、検出方法及び検出用キット
JP4612380B2 (ja) * 2004-09-24 2011-01-12 日本クラウンコルク株式会社 ストローにより開口形成が可能なプラスチックキャップ
JP2006248574A (ja) * 2005-03-10 2006-09-21 Kobayashi Kk 充填食品容器
JP4697783B2 (ja) * 2005-07-29 2011-06-08 株式会社ミズホメディー 検体検出用抽出容器
NL2001577C2 (nl) * 2008-05-14 2009-11-17 Medavinci Dev B V Inrichting en werkwijze voor scheiden en analyseren van bloed.

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005071388A1 (fr) * 2004-01-21 2005-08-04 Orion Diagnostica Oy Dispositif d'echantillonnage et de dosage
EP1867972A1 (fr) * 2005-03-14 2007-12-19 Nipro Corporation Récipient d échantillonnage de liquide
EP1909089A1 (fr) * 2005-06-08 2008-04-09 Nipro Corporation Recipient pour prelevement d' echantillons en phase liquide
WO2008038653A1 (fr) * 2006-09-27 2008-04-03 Shin Corporation procédé de traitement d'échantillon et trousse d'essai
US20080251489A1 (en) * 2007-04-16 2008-10-16 Becton, Dickinson And Company Pierceable cap
EP1994986A1 (fr) * 2007-05-15 2008-11-26 ABS Advanced Biomedical Systems Srl Procédé et dispositif d'extraction antigène rapide
WO2009075637A1 (fr) * 2007-12-10 2009-06-18 Astrazeneca Ab Bouchon de flacon

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3431953A4 (fr) * 2016-03-15 2019-09-25 Sekisui Medical Co., Ltd. Récipient de test et procédé de test l'utilisant
US11255756B2 (en) 2016-03-15 2022-02-22 Sekisui Medical Co., Ltd. Testing vessel and testing method employing same
WO2018025046A3 (fr) * 2016-08-05 2018-05-11 Nn Scientific Limited Dispositif
US11291986B2 (en) 2017-02-24 2022-04-05 Becton, Dickinson And Company Unique sample transfer device for an automated pipettor for processing a variety of clinical microbiological specimens
CN110271750A (zh) * 2019-07-24 2019-09-24 苏州天茹生物科技有限公司 一种用于生物医疗用样品存放盒
CN113109582A (zh) * 2021-04-08 2021-07-13 埃妥生物科技(杭州)有限公司 一种样本提取器以及样本的提取方法
CN116430042A (zh) * 2023-04-14 2023-07-14 河南师范大学 一种简易鼻咽拭子抗原检测装置及检测方法
CN116430042B (zh) * 2023-04-14 2024-04-05 河南师范大学 一种简易鼻咽拭子抗原检测装置及检测方法

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