Specification

[TECHNICAL FIELD]

The present invention relates to a test kit used to collect a specimen from a patient's nose, pharynx, conjunctiva, urethra, uterus, vagina, feces, urine, or sputum using a specimen collecting tool and test the collected specimen, and more particularly to a test kit that can test the collected specimen while preventing the specimen from being contacted by a user.

[BACKGROUND ART]

To prepare an immunoassay testing sample, a specimen collected from a test subject such as lacrimation, eye discharge, sputum, saliva, or feces, or a gauze patch or a cotton swab used to clean an affected area is immersed in an extraction liquid put in a test container in advance so that the specimen is dispersed or dissolved therein.

To perform a predefined test to a specimen desirably handled without any contact with a user to avoid contamination, a urinary toxin test kit illustrated in Figs. 10 and 11 , for example, was conventionally used. As illustrated in Figs. 10 and 11 , the test kit is equipped with a cap/container 51 that can be used as a container in which a specimen is put and diluted with a diluent and a cap on one end of the test kit (cap on the side of a filter described below), a filter 53 for filtering a diluted solution 52 obtained by diluting the specimen with the diluent in a filter retainer 55a on one end side of the test kit, and a dripping tube 55 having a nozzle 54 for dripping the diluted solution 52 filtered by the filter 53 on the other end side, and a nozzle-side cap 56 used as a cap on the nozzle 54 side of the dripping tube 55.

When the test kit is used, as illustrated in Fig. 11 , the diluted solution 52 containing the specimen diluted with the diluent is put in the cap/container 51 , and the side of the dripping tube 55 where the filter 53 is provided is then inserted through an opening of the cap/container 51 and farther pushed as far as the other end of the cap/container 51, so that the diluted solution 52 is filtered by the filter 53 and supplied into the dripping tube 55.

Then, a barrel portion 55b of the dripping tube 55 is pressed with fingers to be warped so that the filtered diluted solution 52 in the dripping tube 55 is dripped on a plate 61 impregnated with a test medium to be subjected to a test to detect whether any toxin is present or not (or amount, if any).

When the test kit is used as described above, the urinary toxin test can be efficiently performed.

However, the conventional test kit leaves the nozzle 54 of the dripping tube 55 unclosed. When the test kit is shaken or transversely placed, the diluted solution 52 therein may leak out. Therefore, there is difficulty in sufficiently agitating the diluted solution 52, causing such a problem as contamination or failure to extract the specimen well which may adversely affect a test result.

Another example of conventional specimen housing container is illustrated in Fig. 12. A specimen housing container 76 is equipped with a container body 72 in which a diluted sample 71 including an influenza virus is put, a filter 73 which filters the diluted sample 71 to be ready for a test on a test device 75, and a nozzle 74 which lets the diluted sample 71 filtered by the filter 73 pass therethrough to be supplied to the test device 75 (see PCT International Publication WO 2004/081568).

The specimen housing container 76 disclosed in WO 2004/081568 also leaves the nozzle 74 unclosed, wherein the diluted sample 71 therein may leak out when the specimen housing container 76 is shaken or transversely placed, similarly causing the problem of contamination.

In the case where a highly contagious virus or microorganism is included in a specimen, the process for preparing the testing sample described earlier possibly leads to secondary spread of infection, for example, hospital-acquired infection unless disposal of a used cotton swab or extraction liquid is properly managed.

The applicant of the present application invented a test kit illustrated in Figs. 13 and 14 as a test kit that can process and test a specimen without any contact with a user (see Japanese Patent Application Laid- Open No. 2008-107332).

As illustrated in Figs. 13 and 14, the test kit is provided with: a) a specimen collecting tool 2 having a specimen collector 1 which collects a specimen on one end side; b) a container body 6a which houses therein an extraction liquid used to immerse the specimen collector 1 of the specimen collecting tool 2 after the specimen is thereby collected to transfer the collected specimen thereto, the container body 6a having an opening portion 3 on one end side and a bottom portion 5 having a thin-film portion 4 on the other end side opposite to the side where the opening portion 3 is provided; c) an extraction liquid sealing cap 7a (opening sealing cap 7 used before the specimen is transferred to the extraction liquid 8) which seals the opening portion 3 of the container body 6a to seal the extraction liquid 8 in an enclosed space thereby formed in the container body 6a; d) a sealing cap 7b equipped with a specimen collecting tool housing feature (opening sealing cap 7 used after the specimen is transferred to the extraction liquid 8) for immersing the specimen collector 1 of the specimen collecting tool 2 in the extraction liquid 8 housed in the container body 6a to transfer the collected specimen to the extraction liquid 8 and thereafter seals the specimen collecting tool 2 along with the extraction liquid 8 in an enclosed space 9 (see Fig. 14) thereby formed in the container body 6a without bending the specimen collecting tool 2; a through hole formation sharp edge 12 which forms a through hole (not illustrated) which the extraction liquid 8 travels through in the thin-film portion 4 on the bottom portion 5 of the container body 6a when the container body 6a is sealed by the sealing cap 7b equipped with a specimen collecting tool housing feature, an opening/sealing tool 14 having a liquid passage 13 where that the extraction liquid 8 having passed through the through hole travels to be taken out of the container; and e) a liquid passage sealing cap 15 which seals the liquid passage 13 after at least a part of the extraction liquid 8 is obtained from the container through the through hole formed in the thin-film portion 4 of the container body 6a by way of the liquid passage 13 to be finally subjected to a test.

The test kit can avoid unfavorable events such as any physical contact with the specimen and exposure or scattering of the specimen, thereby efficiently handling any specimens difficult to handle without causing contamination, for example, specimen to be subjected to an influenza virus test throughout the process which starts with the collection of the specimen using the specimen collecting tooi and ends with the disposal of the tested specimen.

A problem of the test kit is a dimensional increase when the specimen collecting tool is housed in the container body 6a with the sealing cap 7b equipped with a specimen collecting tool housing feature mounted thereon. Therefore, it is desirable to accomplish a test kit further downsized in view of transportation to a test facility and storage efficiency before the specimen is tested.

[DISCLOSURE OF THE INVENTION] [PROBLEMS TO BE SOLVED BY THE INVENTION]

The present invention has been made to solve the above problems, and an object thereof is to provide a small test kit that can efficiently and safely handle and process any specimens which are desirably neither exposed to an external environment nor contacted by a user to avoid contamination, for example, specimens used to test infectious bacteria and viruses such as highly contagious influenza virus and adenovirus, and tubercle bacterium or bird influenza virus possibly leading to secondary infection.

[EFFECT OF THE INVENTION]

These aims and others besides, which will more fully emerge from the following description, are substantially attained by a test kit as set out in one or more of the accompanying claims, taken one by one or in combination, or in any combination with one or more of the described characteristics.

The test kit according to the present invention (claim 1) includes a) a specimen collecting tool having a small diameter portion, a large diameter portion, and a specimen collector provided on the first end side of the small diameter portion, b) a cylindrical container for hermetically housing an extraction liquid, the extraction liquid being used as an immersion liquid where the specimen-attached specimen collector is immersed such that the specimen is transferred into the extraction liquid, the container having an opener/closer for inserting the specimen collecting tool after the specimen is collected into the container by releasing the hermetic state, the opener/closer hermetically closing the inside of the container after the insertion of the specimen collecting tool is completed, and an extraction liquid discharger for discharging the extraction liquid out of the container by releasing the hermetic state after the transfer of the specimen into the extraction liquid is completed to subject the specimen to a test and thereafter hermetically sealing the container again, wherein 1) the small diameter portion is bent when the specimen collecting tool is inserted into the container and then farther pushed into the rear side thereof, and at least two cross sections of the small diameter portion are present in a cross section of the container orthogonal to the axial direction at least one axial position in the inside space of the container, and the length of specimen collecting tool after the small diameter portion is bent is at most 67% (2/3) of the length of the specimen collecting tool before the small diameter portion is bent, 2) when the opener/closer of the container which houses therein the specimen collecting tool bent in the step 1) is closed, the extraction liquid and the specimen collecting tool can be hermetically enclosed in the inside space of the container. The test kit thus structurally characterized can be downsized without sacrificing the handleability of the test kit when the specimen is collected. The test kit can further efficiently and safely handle and process any specimens which are desirably neither exposed to an external environment nor contacted by a user throughout the process which starts with the collection of the specimen using the specimen collecting tool and ends with the disposal of the tested specimen. More specifically, when the specimen is collected in a hospital ward and then transported to a laboratory or an authorized testing institution and disposed of after tested in the laboratory or testing institution, the test kit can protect the obtained specimen throughout the process from any contact with an external environment or anyone who handles the specimen, ensuring safe handling and processing of the specimen. The length of the specimen collecting tool in the axial direction of the container after the small diameter portion is bent can be adjusted to at most 67% (2/3) of the length before the small diameter portion is bent by adjusting a dimensional relationship between the small and large diameter portions and a dimensional relationship between the small and large diameter portions and the axial length of the inside space of the container. When the length of the specimen collecting tool in the axial direction of the container after the small diameter portion is bent can be adjusted to at most 67% (2/3) of the length before the small diameter portion is bent, the test kit can achieve a significant downsizing in practical use. There are no particular restrictions to the specific configurations of the opener/closer inserting the specimen collecting tool after collecting the specimen into the container and hermetically sealing the inside of the container after the insertion of the specimen collecting tool is completed, and the extraction liquid discharger for discharging the extraction liquid out of the container by releasing the hermetic state to subject the specimen to the test, and thereafter hermetically sealing the container again, and various conventional mechanisms can be adopted. There are no particular restrictions to the positions at which the opener/closer and the extraction liquid discharger are provided. The opener/closer and the extraction liquid discharger may be respectively provided on the first end side and the second end side of the container. Another possible structure is to provide the opener/closer on the first end side of the container and provide an openable/closable nozzle as the extraction liquid discharger in a part of the opener/closer (for example, sealing cap constituting the opener/closer).

According to claim 2, the preliminary bending process is applied to the predetermined position of the specimen collecting tool in the axial direction of the large diameter portion so as to allow the large diameter portion to be cut and separated at the predetermined position when being bent, and the container is so configured as hermetically house and seal therein, after the large diameter portion is cut and separated at the position to which the preliminary bending process is applied, the specimen collecting tool from which the large diameter portion is cut and separated, subsequent to the collection of the specimen. Further, the length of the cut and separated large diameter portion and the length of the specimen collecting tool in the axial direction of the container after the small diameter portion is bent and the large diameter portion is partly cut and separated are at most 50% of the length of the specimen collecting tool before the large diameter portion is cut and separated and the small diameter portion is bent. According to the structural characteristic, the test kit after the specimen is thereby collected can be efficiently reduced in size while ensuring the length of the large diameter portion large enough to collect the specimen without difficulty. By suitably adjusting the position at which the large diameter portion is cut and separated and the dimensional relationship between the length of the small diameter portion and the axial length of the container, the length of the bent specimen collecting tool can be surely reduced to at most 50% of the length of the specimen collecting tool before bending.

According to the test kit of claim 3, the length of the cut and separated large diameter portion and the length of the specimen collecting tool in the axial direction of the container after the small diameter portion is bent and the large diameter portion is partly cut and separated are at most 40% of the length of the specimen collecting tool before the large diameter portion is cut and separated and the small diameter portion is bent. The structural characteristic can further realize the effect of the present invention by further downsizing the test kit, which is convenient for storage and transportation of the test kit.

According to claim 4, the length of the specimen collecting tool before the small diameter portion is bent is 0.8 to 2.2 times the axial length of the inside space of the container. According to the structural characteristic, the small diameter portion can be surely bent without difficulty, and the downsizing effect obtained by bending the small diameter portion can be increased, which is effective.

According to claim 5, a cotton swab having a cotton ball on the first end thereof corresponding to the edge of the small diameter portion, is used as the specimen collecting tool. The structural characteristic makes it unnecessary to provide any specially designed tool in the test kit to collect the specimen, thereby further realizing the effect of the present invention.

The "cotton swab" does not literally mean a cotton-made member, and can be made of synthetic fiber such as nylon, or polyester, or synthetic fiber may be flock-finished in the form of a spherical cotton ball. The specimen collecting tool according to the present invention is not necessarily limited to the cotton swab. Any other specimen collecting tools provided with specimen collectors in different forms on the first end side, such as a brush, can be used as far as they can collect and retain the specimen.

According to claim 6, the container includes the opener/closer provided on the first end side thereof and having the opening and the opening sealing lid for sealing the opening, the opener/closer inserting the specimen collecting tool after collecting the specimen into the container by operating the opening sealing lid to release the hermetic state, and further hermetically sealing the inside of the container by operating the opening sealing lid after the insertion of the specimen collecting tool is completed, and the extraction liquid discharger provided on the second end side of the container opposite the side where the opening portion is provided, the extracting liquid discharger having the sealing feature for discharging the extraction liquid out of the container by releasing the hermetic state after the transfer of the specimen into the extraction liquid is completed to subject the specimen to a test, and thereafter hermetically sealing the container again. The test kit thus structurally characterized can further efficiently and safely handle and process any specimens which are desirably neither exposed to an external environment nor contacted by a user throughout the process which starts with the collection of the specimen using the specimen collecting tool and ends with the disposal of the tested specimen, thereby further realizing the effect of the present invention.

According to claim 7, the extraction liquid discharger includes the thin-film portion provided on a bottom portion on the second end side facing the first end side where the opening portion is provided, the 5 opening/sealing tool having the through hole formation sharp edge for forming the through hole for the extraction liquid to pass therethrough in the thin-film portion and the liquid passage disposed to allow the extraction liquid passing through the through hole to be discharged out of the container, and the liquid passage sealing lid for sealing the liquid passage after at least the portion of the extraction liquid passing through the through hole formed in the thin-film portion is discharged out of the container via the liquid0 passage to subject the specimen to a test. When the opening/sealing tool is pushed into the opening/sealing tool housing region so that the through hole is formed in the thin-film portion on the bottom portion of the container, the extraction liquid can be distributed via the liquid passage to be subjected to a test, and thereafter the liquid passage can be sealed. Thus, the present invention can further realize its effect.

5 According to claim 8, a) the bottom portion of the container is disposed to have the upward shape at the position behind the edge of the container on the second end side, and b) the opening/sealing tool has the cylindrical portion fitted into the opening/sealing tool housing region on the inner-peripheral side of the container in close contact with the inner-peripheral of the container; a through hole formation sharp edge provided on the first end side of the cylindrical portion, and the liquid removal flow channel o communicating with the inner portion of the cylindrical portion and having the end serving as the port for collecting the extraction liquid and also serving as the sealing lid attaching portion to which the liquid passage sealing lid for sealing the liquid passage is attached, the liquid removal flow channel constituting the liquid passage in conjunction with the inner portion of the cylindrical portion, wherein the space between the opening/sealing tool and the container is sealed and the through hole is formed in the thin- 5 film portion on the bottom portion of the container when the opening/sealing tool is pushed into the opening/sealing tool housing region. According to the structural characteristic, the space between the opening/sealing tool and the container can be sealed, the through hole can be formed in the thin-film portion on the bottom portion of the container when the opening/sealing tool is pushed into the opening/sealing tool housing region of the container, and the extraction liquid can be reliably obtained through the liquid removal flow channel alone. Thus, the present invention can further realize its effect. According to the test kit of claim 9, the test kit further includes the filter for filtering and removing a solid matter in the liquid passage of the opening/sealing tool. According to the structural characteristic, the extraction liquid including the specimen can be filtered to remove any solid matter therefrom and then subjected to the test. The test kit having the configuration of claim 9 can be an effective tool for handling any specimens including a solid matter. The test kit according to the present invention may have as specimen collecting tool a flocked swab, having a flocked collecting portion defined by a plurality of fibers attached to an edge of the small diameter portion by means of flocking, as recited in claim 10.

The test kit according to the present invention is suitable for testing any infectious diseases as recited in claim 11. The test kit enables any infectious diseases to be tested safely and efficiently. The test kit according to the present invention is suitable for testing any influenza viruses as recited in claim 10. The test kit enables any influenza viruses to be tested safely and efficiently. The invention relates also to the use of a test kit according to any of the preceding claims for carrying out tests of biological material. [BRIEF DESCRIPTION OF DRAWINGS]

By way of non-limiting examples, a detailed description will now follow of some preferred embodiments of the invention, in which:

Fig. 1 is an exploded view (cross sectional view of main structural elements) of a test kit comprising a specimen collecting tool and a container according to an embodiment of the present invention.

Fig. 2 is a view of a processing step in a method of using the test kit according to the embodiment of the present invention, illustrating a state where a specimen collector of the specimen collecting tool is immersed in an extraction liquid.

Fig. 3 is a view of a processing step in the method of using the test kit according to the embodiment of the present invention, illustrating the state where the specimen collector of the specimen collecting tool is immersed in the extraction liquid and farther pushed into the container so that a small diameter portion is deformed in a loop shape.

Fig. 4 illustrates a state where a large diameter portion of the specimen collecting tool is bent at a position where a notch is formed in the state of Fig. 3 and cut off and separated from the specimen collecting tool.

Fig. 5 illustrates a state where an opening portion of the container is sealed with an opening sealing lid after the specimen collecting tool is housed in the container.

Figs. 6a and 6b are views of an opening/sealing tool constituting the test kit according to the embodiment of the present invention, wherein Fig, 6a is a front sectional view, and Fig. 6b is a side view.

Figs. 7a and 7b are front sectional views of a processing step in the method of using the test kit according to the embodiment of the present invention, illustrating formation of a through hole in a thin-film portion on a bottom portion of the container, and Fig. 7c is a side sectional view wherein the opening/sealing tool is not illustrated in cross section.

Fig. 8 is a cross sectional view of the test kit taken along line P-P in Fig. 3.

Fig. 9 is a view of a processing step in the method of using the test kit according to the embodiment of the present invention, illustrating a state where the extraction liquid is taken out of the container through the through hole via a liquid passage.

Fig. 10 is a view of a conventional container used as a urinary toxin test kit.

Fig. 11 is an explanatory view of a method of using the conventional container of Fig. 10.

Fig. 12 is a view of another example of the conventional specimen housing container.

Fig. 13 is an exploded view of the conventional test kit.

Fig. 14 is an explanatory view of a method of using the conventional test kit.

[BEST MODE FOR CARRYING OUT THE INVENTION]

Hereinafter, advantageous structural characteristics of the present invention are described in further detail based on an embodiment. [First Embodiment]

In a first embodiment, a test kit used to test an influenza virus is described by way of example.

Fig. 1 is an exploded view (cross sectional view of main structural elements) of an influenza virus test kit according to an embodiment of the present invention.

As illustrated in Fig. 1, the test kit according to the embodiment includes a specimen collecting tool 2 and a bottomed container 6 having an cylindrical shape.

The specimen collecting tool 2 has a small diameter portion 41 extending from a predefined position to a first end thereof and deformable when a force is applied thereto, and a large diameter portion 42 extending from a position where the small diameter portion 41 ends to a second end. The large diameter portion 42 is not largely deformed when the specimen collecting tool 2 is held to collect a specimen. Further, the large diameter portion 42 has a diameter larger than that of the small diameter portion 41 and has such rigidity that its axial dimension does not change when the specimen collecting tool 2 is inserted and farther pushed into the container 6 in a subsequent step. The specimen collecting tool 2 further has a specimen collector 1 provided on the first end side of the small diameter portion 41 for collecting and retaining the specimen. The small diameter portion 41 and the large diameter portion 42 of the specimen collecting tool 2 are made of resin and integrally formed. In the embodiment, the resin used to from the small diameter portion 41 and the large diameter portion 42 is polystyrene. Examples of the resin other than polystyrene used as the material of the small diameter portion 41 and the large diameter portion 42 of the specimen collecting tool 2 include polyethylene and polypropylene, and material other than these resins are also usable. Though the material used to form the small diameter portion 41 and the large diameter portion 42 of the specimen collecting tool 2 is not particularly limited, the small diameter portion 41 should be made of any material that can make the small diameter portion 41 be deformed in such a manner that the effect of the present invention is exerted in the small diameter portion 41 when the specimen collecting tool 2 is inserted and farther pushed into the container 6.

The small diameter portion 41 may be formed so that its diameter starts to gradually increase and its rigidity correspondingly increases at a position near the large diameter portion 42. When the small diameter portion 41 is thus formed, the handleability of the specimen collecting tool 2 may be improved when the specimen collecting tool 2 collects the specimen and the specimen collecting tool 2 after the specimen is thereby collected is pushed into the container 6 to bend the small diameter portion.

The specimen collecting tool 2 used herein is a cotton swab having a cotton ball as the specimen collector 1 on the first end thereof corresponding to an edge of the small diameter portion 41. To form the cotton ball of the cotton swab, synthetic fiber may be flock-finished. Other than the cotton swab, any specimen collecting tools provided with specimen collectors in different forms on the first end side, such as a brush, can be used as far as they can collect and retain the specimen.

The container 6 hermetically houses and seals therein an extraction liquid 8 where the specimen collector 1 , to which the collected specimen is attached, of the specimen collecting tool 2 is immersed so that the specimen is transferred thereto.

The container 6 is provided with an opening portion 3 on the first end side thereof (upper-end side in Fig. 1), and an opening sealing lid 7 for sealing the opening portion 3, wherein the opening sealing lid 7 is operated to release the hermetic state so that the specimen collecting tool 2 after collecting the specimen is inserted into the container, and the opening sealing lid 7 is operated after the insertion of the specimen collecting tool 2 is completed to hermetically seal the inside of the container 6 again. In the embodiment, the opening portion 3 and the opening sealing lid 7 constitute the opener/closer.

The opening portion 3 and the opening sealing lid 7 are each provided with a thread so that the opening portion 3 is sealed by the opening sealing lid 7 when the threads are engaged with each other.

On the other end side opposite to the side where the opening portion 3 of the container 6 (lower-end side in Fig. 1) is provided, an extraction liquid discharger 10 having a hermetic sealing feature for discharging the extraction liquid 8 out of the container by releasing the hermetic sate after the transfer of the specimen to the extraction liquid 8 is completed to subject the specimen to the test and thereafter hermetically sealing the container again.

In the test kit according to the embodiment, the specimen collecting tool 2 after collecting the specimen is inserted in the container 6 through the opening portion 3 of the container 6 with the specimen collector 1 first so that the specimen collector 1 is immersed in the extraction liquid 8 as illustrated in Fig. 2. When the specimen collecting tool 2 is farther pushed into the rear side thereof as illustrated in Fig. 3, the small diameter portion 41 is bent (curved in a loop shape in the embodiment) so that the length of the whole specimen collecting tool 2 is reduced.

A preliminary bending process (for example, notch 43 (bending process to form a notch 43 (e.g., Fig. 1)) is applied to a predetermined position of the specimen collecting tool 2 in an axial direction of the large diameter portion 42. When the large diameter portion 42 is bent at the position where the notch 43 is formed, the large diameter portion 42 is cut and separated so that the specimen collecting tool 2 further reduced in length can be hermetically housed and sealed in the container 6 (see Figs. 4 and 5).

In the present invention, the lengths of the small diameter portion 41 and the large diameter portion 42 of the specimen collecting tool 2 and the axial length of the container 6 are decided so that the length of the specimen collecting tool 2 in the axial direction of the container 6 after the small diameter portion 1 is bent or the small diameter portion 1 is bent and the large diameter portion is cut and separated therefrom are at most 50% of the length of the specimen collecting tool before the large diameter portion is cut and separated and the small diameter portion 41 is bent.

In the embodiment, a length Li of the small diameter portion 41 and a length l_2 of the large diameter portion 42 in the specimen collecting tool 2 are substantially equal. The notch 43 is formed at such a position that approximately 2/3 of the large diameter portion 42 can be bent off (position at approximately 2/3 from the top of the large diameter portion in Fig. 1). Further, generally in the present invention, the length Li of the small diameter portion 41 in the specimen collecting tool 2 before bending (Fig. 1) is desirably 0.8 to 2.2 times the axial length Ls of an inside space S of the container 6 (Figs. 1 and 3). In the embodiment, the Li/Ls = 1.05.

In the test kit according to the present embodiment, when the whole specimen collecting tool 2 is housed in the container 6 after the small diameter portion 42 is bent and the large diameter portion is cut and separated from the specimen collecting tool 2 at the intermediation position thereof, the opening portion 3 of the container 6 is sealed with the opening sealing lid 7, and the specimen collecting tool 2 can be hermetically enclosed in the container 6 (see Fig, 5).

The extract liquid discharger 10 of the container 6 has a thin-film portion 4 provided on a bottom portion 5 on the second end side opposite to the first end side where the opening portion 3 is provided, a opening/sealing tool 14 (see Figs. 6a and 6b) having a through hole formation sharp edge 12 for forming a through hole 11 (see Figs. 7b and 7c) for the extraction liquid 8 to pass through in the thin-film portion 4 and a liquid passage 13 disposed to allow the extraction liquid having passed through the though hole 11 to be discharged out of the container; and a liquid passage sealing lid 15 for sealing the liquid passage 13 after at least a portion of the extraction liquid passing through the through hole 11 formed in the thin- film portion 4 is discharged out of the container via the liquid passage 13 to subject the specimen to the test.

The configuration of the extraction liquid discharger 10 of the container 6 is described in further detail. As illustrated in Figs. 1 , 6a and 6b, and 7a to 7c, the bottom portion 5 of the container 6 is disposed to have an upward shape at a position behind an edge of the container 6 on the second end side. As illustrated in Figs. 6a and 6b, and Figs. 7a to 7c, the opening/sealing tool 14 has a cylindrical portion 1 fitted into an opening/sealing tool housing region 16 extending from the second end side to the bottom portion 5 on the inner-peripheral side of the container 6 in close contact with an inner peripheral surface of the container 6; a through hole formation sharp edge 12 provided on the first end side of the cylindrical portion 17; and a liquid removal flow channel 19 communicating with an inner portion of the cylindrical portion 17 and having an end serving as a port 18 for collecting the extraction liquid and also serving as a sealing lid attaching portion to which the liquid passage sealing lid 15 for sealing the liquid passage 13 is attached, the liquid removal flow channel 19 constituting the liquid passage 13 in conjunction with the inner portion of the cylindrical portion 17, wherein a space between the opening/sealing tool 14 and the container 6 is sealed when the opening/sealing tool 14 is pushed into the opening/sealing tool housing region 16, and the through hole 11 is formed in the thin-film portion 4 on the bottom portion 5 of the container 6.

In the test kit according to the embodiment, to help the extraction liquid 8 in the container 6 be readily obtained from the container, the through hole formation sharp edge 12 of the opening/sealing tool 14 has a tip-side thin portion 12a, a base-side thick portion 12b, and a stepped portion 12c is formed between the tip-side thin portion 12a and the base-side thick portion 12b as illustrated in Figs. 6a and 6b. According to the configuration, as illustrated in Figs. 7a to 7c, the stepped portion 12c pushes and thereby deforms the thin-film portion 4 on the bottom portion 5 of the container 6 so that gaps are more easily formed near the through hole 11. Then, the extraction liquid 8 in the container 6 can be more surely taken out of the container through the gaps. The tip-side thin portion 12a breaks the thin-film portion 4 of the bottom portion 5, and the stepped portion 12c surely pushes the broken thin-film portion 4 upward. Thus, the passage for the extraction liquid 8 can be surely formed near the through hole 11 , and the extraction liquid 8 in the container 6 can be surely taken out of the container through the passage. As illustrated in Fig. 6a, the liquid passage 13 of the opening/sealing tool 14 is provided with a filter 20 for filtering the extraction liquid to remove a solid matter therefrom so that the extraction liquid 8, if any solid matter resulting from the specimen is included therein, can be filtered to remove the solid matter therefrom and then subjected to the test. The filter 20 may exert an effect of reducing viscosity of the extraction liquid containing the extracted specimen.

In the test kit according to the embodiment having the above configuration, when the opening/sealing tool 14 is pushed into the opening/sealing tool housing region 16 of the container 6, the through hole 11 is formed in the thin-film portion 4 on the bottom portion 5 of the container 6, and any space between the opening/sealing tool 14 and the container 6 can be sealed. As a result, the extraction liquid 8 can be reliably obtained from the liquid removal flow channel 19 alone without any leak of the extraction liquid 8 through any other portion.

In the through hole formation sharp edge 12 of the opening/sealing tool 14, a slit 21 (see Figs. 6b and Fig. 7c) is formed substantially in parallel with a direction where the thin-film portion 4 on the bottom portion 5 of the container 6 is broken. When the through hole formation sharp edge 12 breaks the thin- film portion 4 on the bottom portion 5 of the container 6 to form the through hole 11 , the extraction liquid 8 in the container 6 can be more reliably obtained through the slit 21.

In the test kit according to the embodiment, all of the structural elements of the test kit but the specimen collecting tool 2 are made of a material transparent or semi-transparent and having plasticity (low-density polyethylene in the embodiment) so that the content volume can be visually confirmed. The test kit is further structurally characterized in that when the container 6 is pressed to be deformed (for example, the barrel portion of the container 6 is lightly pressed) after the through hole 11 (see Figs. 7b and 7c) is formed, the extraction liquid 8 can be dripped through the discharge port 18 at the tip of the liquid passage 13 of the opening/sealing tool 14.

Next, a method of using the test kit, more specifically, a method of processing the specimen using the test kit to subject the specimen to an influenza virus test is described.

1) First, a specimen (for example, mucosa in throat) is collected by the specimen collecting tool 2 having the specimen collector 1 used to collect the specimen on one end side thereof.

2) The opening sealing lid 7 is removed from the opening portion 3 of the container 6 provided with the bottom portion 5 having the thin-film portion 4. Then, as illustrated in Fig. 2, the specimen collecting tool 2 after collecting the specimen is inserted in the container 6 through the opening portion 3 thereof with the specimen collector 1 first so that the specimen collector 1 of the specimen collecting tool 2 is immersed in the extraction liquid 8 in the container 6. Then, the specimen collecting tool 2 is father pushed into the container 6 so that the small diameter portion 41 is deformed in the loop shape as illustrated in Fig. 3,

Fig. 8 is a cross sectional view of the test kit taken along line P-P in Fig. 3. More specifically, Fig. 8 is a cross sectional view of the test kit cut at least one axial position (cross sectional position of the test kit taken along the line P-P) of the inside space S of the container 6 in a direction orthogonal to the axial direction of the inside space S as illustrated in Fig. 3, wherein three cross sections of the small diameter portion 41 are present. When the peak position of the bended part of the small diameter portion 41 is cut along the line P-P, only two cross sections of the small diameter portion 41 may be present.

3) As illustrated in Fig. 4, when the large diameter portion 42 of the specimen collecting tool 2 is bent at the position where the notch 43 is formed as a preliminary bending process, the large diameter portion 42 is cut and separated from the specimen collecting tool 2. When the small diameter portion 41 is bent and the large diameter portion 42 is cut and separated at the position where the notch 43 is formed, the length of a cut and separated part 42a of the large diameter portion 42 and the length of the specimen collecting tool 2 in the axial direction of the container 6 after the small diameter portion 41 is bent and the part 42a of the large diameter portion 42a is cut and separated are at most 50% (at most 1/2) of the original length of small diameter portion 4 of the specimen collecting tool 2 (specimen collecting tool illustrated in Fig. 1) in the axial length of the container 6 before bending.

The small diameter portion is not necessarily deformed in the loop shape, but may be deformed in the shape of largely curved S or a winding shape including a plurality of largely curved S-shape parts. 4) The whole specimen collecting tool 2 including the cut and separated part 42a of the large diameter portion 42 is housed in the container, and the opening portion 3 of the container 6 is sealed with the opening sealing lid 7 so that the specimen collecting tool 2 along with the extraction liquid 8 is hermetically sealed in the inside space S formed by the container 6 and the opening sealing lid 7 as illustrated in Fig. 5. When the extraction liquid 8 is thus hermetically sealed in the inside space S, the specimen can be fully mixed with the extraction liquid when the container 6 is oscillated or shaken.

In the present invention, a side wall portion of a region 31 near the second end side (Fig. 1) provided with the bottom portion 5 of the container 6 is desirably more flexible than a side wall portion of a region 32 near the first end side (Fig. 1) provided with the opening portion 3. More specifically, the side wall portion of the region 31 near the second end side (Fig. 1) provided with the bottom portion 5 of the container 6 is preferably very flexible that can be deformed when pressed with fingers but also resilient enough to restore its original shape when no longer pressed.

To make the side wall portion of the region 31 near the second end side provided with the bottom portion 5 of the container 6 more flexible than the side wall portion of the region 32 near the one end side provided with the opening portion 3, for example, the side wall portion of the region 31 near the second end side is formed thinner than the side wall portion of the region 32 near the first end side. When the side wall portion of the region 31 near the second end side thus formed is pressed so that the specimen collector 1 of the specimen collecting tool 2 is thereby rubbed, the specimen collector 1 can suck up the extraction liquid 8 well, and the specimen can be more efficiently extracted. To discharge the extraction liquid 8 out of the container 6, the extraction 8 can be speedily discharged when the side wall portion of the region 31 near the second end side is simply pressed.

5) As illustrated in Fig. 7a, in the thin-film portion 4 on the bottom portion 5 of the container 6, the opening/sealing tool 14 having the through hole formation sharp edge 12 is fitted to the inner peripheral side of the bottom portion 5 of the container 6 with the liquid passage sealing lid 15 mounted thereon, and then pushed farther into the container 6 toward its bottom as illustrated in Figs. 7b and 7c, so that the through hole formation sharp edge 12 of the opening/sealing tool 14 forms the through hole 11 in the thin- film portion 4 on the bottom portion 5 to let the extraction liquid 8 pass therethrough. The liquid passage sealing lid 15 mounted on the container can prevent the extraction liquid 8 from leaking even after the formation of the through hole 11.

6) As illustrated in Fig. 9, the liquid passage sealing lid 15 is thereafter removed to take out at least a portion of the extraction liquid 8 through the through hole 11 formed in the thin-film portion 4 of the container 6 via the liquid passage 13 to subject the specimen to the test.

Because of the slit 21 and the stepped portion 12c formed in the through hole formation sharp edge 12 of the opening/sealing tool 14 substantially in parallel with the direction where the thin-film portion 4 is broken, the stepped portion 12c abuts vicinity of the through hole in the thin-film portion 4 on the bottom portion 5 of the container 6 when the through hole formation sharp edge 2 breaks through the thin-film portion 4 on the bottom portion 5 of the container 6 to form the through hole 11 , thereby deforming the thin-film portion 4 as illustrated in Figs. 7b and 7c. Then, the gaps which the extraction liquid 8 passes through are easily formed near the through hole 11 , and the slit 21 serves as the passage of the extraction liquid 8. Therefore, the extraction 8 can be taken out without fail and readily subjected to the test.

7) When the liquid passage 13 is sealed with the liquid passage sealing lid 15 after the extraction liquid 8 is obtained (as illustrated in Figs. 7b and 7c) to prevent leakage of the extraction liquid 8, the whole test kit can be discarded (for example, the used test kits are collectively put in a dedicated disposal container and then discarded). The test kit described so far can efficiently and safely handle and process any specimens which are desirably neither exposed to an external environment nor contacted by a user to avoid contamination, for example, specimens used to test infectious bacteria.

The liquid passage sealing lid 15 may be formed in the shape of such a cap that can cover all of a lower section of the opening/sealing tool 14. The lid formed in such a shape can prevent the risk of contamination by covering any parts to which the extraction liquid is possibly attached after the extraction liquid containing the extracted specimen is dripped from the liquid removal flow channel 19 of the opening/sealing tool 14. In the embodiment, a part of the large diameter portion constituting the specimen collecting tool is cut and separated. When the large diameter portion constituting the specimen collecting tool is designed to have a smaller length, it is unnecessary to cut and separate a part of the large diameter portion to make the specimen collecting tool small enough to be sealed in the container after the specimen is collected. The present invention is not necessarily limited to the embodiment in any other aspects, and various modifications within the scope of the invention can be made to the technical feature of the specimen collecting tool having the specimen collector, specific requirement for deforming the specimen collecting tool, structures of the container and the opening sealing lid, and technical feature of the opening/sealing tool.

[INDUSTRIAL APPLICABILITY]

As described so far, the present invention provides a test kit that can efficiently and safely handle and process any specimens which are desirably neither exposed to an external environment nor contacted by a user to avoid contamination, for example, specimens used to test infectious bacteria and viruses. The present invention is applicable to the technical fields relevant to the processing of specimens and test kits used for the purpose. The invention provides a test kit reduced in size that can efficiently and safely handle and process any specimens which are desirably neither exposed to an external environment nor contacted by a user to avoid contamination.

[DESCRIPTION OF REFERENCE NUMERAL]

1 specimen collector 2 specimen collecting tool

3 opening portion

4 thin-film portion

5 bottom portion

6 container

7 opening sealing lid

8 extraction liquid

10 extraction liquid discharger

11 through hole

12 through hole formation sharp edge

12a tip-side thin portion

12b base-side thick portion

12c stepped portion

13 liquid passage

14 opening/sealing tool

15 liquid passage sealing lid

16 opening/sealing tool housing region

17 cylindrical portion

18 discharge port

19 liquid removal flow channel

20 filter

21 slit

31 region near second end side

32 region near first end side

41 small diameter portion

42 large diameter portion S inside space of container

Li length of small diameter portion before bending

L.2 length of large diameter portion

L.3 axial length of inside space of container