JP6182526B2 - Sugar chain antigen extraction kit and detection kit - Google Patents

Description

  The present invention relates to a sugar chain antigen extraction kit and a detection kit. For example, when examining whether or not a group A β streptococcus pyogenes antigen is present in a pharyngeal swab collected from the pharynx of a subject. It is suitable for application.

  Conventionally, as a detection kit for examining the presence or absence of a group A β-hemolytic streptococcal antigen, a group A β-hemolytic streptococcal antigen kit used by mixing two kinds of chemicals immediately before use is known (for example, non- Patent Document 1). Actually, this group A β-hemolytic streptococcal antigen kit is composed of, for example, a first bottle containing a chemical solution A containing 2 [mol / L] sodium nitrite and 0.2 [mol / L] acetic acid as components. It is composed of a second bottle containing medicinal solution B, a test tube-shaped extraction tube, a cotton swab for collecting a specimen from the pharynx, which is an inflamed part of the subject, and a test strip for determining positive or negative. .

  In this group A β-hemolytic streptococcal antigen kit, nitrite is used in order to release and extract the group A β-hemolytic streptococcal antigen, which is a polysaccharide antigen, from the cells, and a mixed drug solution containing nitrite immediately before use Is generated. Actually, in this group A β-hemolytic streptococcal antigen kit, just before use, as shown in FIG. 9A, several drops of the drug solution A in the first bottle 101 and the drug solution B in the second bottle 102, It is dripped at the tube 100 for extraction, and the mixed chemical | medical solution which uses nitrous acid as a component is produced | generated as a specimen extract.

  Here, as shown in FIG. 9B, the extraction tube 100 has an outer shape that can be picked by the user with one finger F, and in the state of being gripped by the finger F, The swab 105 can be gripped. In this case, the user prepares a cotton swab 105 in which an inflamed part such as the pharynx of the subject is wiped with a tip cotton ball part 105a and a throat swab is collected as a specimen. Next, the tip cotton ball portion 105a of the cotton swab 105 from which the specimen was collected is immersed in the mixed chemical solution in the extraction tube 100, and the tip cotton ball portion 105a is extracted by slightly crushing the extraction tube 100 with the abdomen of the thumb and index finger. The tube 100 is lightly sandwiched between both side walls, and the mixed drug solution is swirled with the tip cotton ball 105a, and then left for about 1 minute.

  Next, as shown in FIG. 10A, the user crushes the extraction tube 100 with the thumb and forefinger, and the tip cotton ball portion 105a in the extraction tube 100 passes through the side wall of the extraction tube 100. The cotton swab 105 is taken out from the extraction tube 100 while strongly picking and squeezing out the specimen and the mixed chemical liquid soaked into the tip cotton ball part 105a. In this way, in the extraction tube 100, a test solution can be generated in which the sample collected at the tip cotton ball part 105a is released into the mixed drug solution.

  Here, since the extraction tube 100 into which the mixed chemical solution is put is formed of a flexible soft material such as an acrylic resin, the user grips it with a finger F to give a predetermined gripping force. It is configured to be deformable until the side walls are crushed and come into close contact with each other. As a result, the extraction tube 100 can securely grip the tip cotton ball portion 105a of the cotton swab 105 placed in the extraction tube 100 from the outside through the side wall, and the tip cotton ball portion 105a through the side wall. A “squeezing operation” can be performed by rubbing in a state where the finger is strongly picked with a finger, and the specimen, the test solution, etc. soaked into the tip cotton ball portion 105a can be surely squeezed out by this ironing operation.

  Finally, as shown in FIG. 10B, after the determination unit of the test strip 110 is immersed in the test solution S2 in the extraction tube 100, the presence or absence of a line due to an antigen-antibody reaction in the determination unit is visually observed after a predetermined time has elapsed. Based on the presence or absence of the appearance of the line, it can be determined whether or not the group A β-hemolytic streptococcal antigen is present in the test solution S2.

"Statcheck TM Strep A-II", [online], search on April 26, 2012, Internet (URL: http://www.info.pmda.go.jp/downfiles/ivd/PDF/531143_22100AMX02226000_A_01_01.pdf )

  However, in the group A β-hemolytic streptococcal antigen kit having such a configuration, the mixed drug solution generated in the extraction tube 100 contains unstable nitrous acid. If stored, it will be altered and cannot be used for testing. Therefore, it must be mixed immediately before use in the medical field, and it must be prepared at the time of use. Therefore, depending on the user, the mixing ratio of the chemical liquid A and the chemical liquid B may be wrong. In that case, there is a problem that a false diagnosis may not be obtained because a false positive may be obtained despite a negative, or a false negative may be obtained despite a positive. It was.

  On the other hand, as a conventional group A β-hemolytic streptococcal antigen kit, for example, a predetermined amount of chemical solution is placed in an outer bottle preliminarily filled with a predetermined amount of chemical solution B in order to solve the problem of such erroneous preparation at the time of use. There is also known an ampoule storage type bottle in which an ampule containing A is stored in advance. In this type of group A β-hemolytic streptococcal antigen kit, when not in use, the drug solution A and the drug solution B are separated by an ampule in the outer bottle, but immediately before use, from a flexible soft material The ampule is crushed by strongly picking the outer bottle with a finger to destroy the ampule, and a predetermined amount of the medicinal solution A in the ampule is mixed with the medicinal solution B in the outer bottle. Can produce a mixed chemical mixed at an optimal mixing ratio.

  However, this type of group A β-hemolytic streptococcal antigen kit can produce a mixed drug solution in which the drug solution A and the drug solution B are mixed at an optimum mixing ratio, but it is necessary to prepare a mixed drug solution immediately before use. In fact, there was a problem that it took time and effort for the user. In addition, the ampoule in the outer bottle may be accidentally destroyed by the user and mixed with drug solution A and drug solution B, or the ampoule is stored for some reason while transporting the group A β-hemolytic streptococcal antigen kit. When an impact is applied to the mold bottle and the ampule in the outer bottle is destroyed, the chemical liquid A and the chemical liquid B are mixed at a timing not intended by the user.

  As described above, when the chemical liquid A and the chemical liquid B are mixed at an unintended timing, the mixed chemical liquid generated in the outer bottle is deteriorated with the passage of time, and then used for the inspection. It is hoped that such an incorrect preparation will not occur because it is not possible.

  The latter ampoule-storing bottle has a complicated configuration in which the ampoule is accommodated in the outer bottle, and each of the chemical solution A and the chemical solution B is dispensed into individual quantities for use once, and is then dispensed into the outer bottle. In addition, since it is necessary to put in each ampule, there is a problem that it takes time and manufacturing cost increases.

  Therefore, the present invention has been made in consideration of the above points, and aims to propose a sugar chain antigen extraction kit and a detection kit that do not require preparation at the time of use and that can reduce the manufacturing cost with a simple configuration. To do.

In order to solve this problem, claim 1 of the present invention includes an airtight container in which a specimen extract containing nitrous acid is sealed in a container part that maintains airtightness, and a collection part that collects a specimen from a subject. wherein said after collecting the specimen by collecting section, the collecting portion is immersed in the specimen extract, and a swab for specimen collection for extracting the analyte in the sample extract from the collecting unit, the collecting The portion is immersed in the sample extract in the opened airtight container, and when the sample is collected from the subject, the sample does not penetrate into the inside of the collection unit, at least capillary action or It has a surface to which the specimen is attached by any one of the surface tensions, and after being immersed in the specimen extract, it is simply pressed against the inner wall of the container section when taken out from the container section. Sample extraction A carbohydrate antigen extraction kit characterized that you release the. Claim 2 of the present invention includes an airtight container in which a specimen extract containing nitrous acid is sealed in advance in a container part that maintains airtightness, and a collection part that collects a specimen from a subject. A sample collection swab for extracting the sample from the collection unit into the sample extraction solution, the collection unit being unsealed. The sample collection swab soaked in the sample extract in the airtight container includes a frog swab having the collection unit covered with a napped surface layer portion, and the collection unit made of a sponge having a porous surface. This is a sugar chain antigen extraction kit, characterized in that it is a sponge swab or a loop comprising the sampling part bent in a loop shape and formed in an O shape.

  Further, in the present invention, as the above airtight container, a specimen extract containing unstable nitrous acid generated in advance by mixing an aqueous solution of sodium nitrite and an acidic solution is enclosed in advance in a container part that maintains airtightness. An airtight container was provided.

  In the present invention, the sample collection swab is provided to extract the sample from the collection unit to the sample extract by pressing the collection unit against a predetermined site in the airtight container.

  In addition, a seventh aspect includes the sugar chain antigen extraction kit according to any one of the first to sixth aspects and an immunochromatographic test strip for detecting group A β-hemolytic streptococci. Detection kit.

According to claim 1 or 2 of the present invention, a specimen extract containing nitrous acid prepared in advance is sealed in an airtight container that maintains airtightness. The specimen extract can be stored for a long time without any need for preparation at the medical site. In addition, incorrect preparation can be prevented and only one solution is sealed in an airtight container. As a result, the manufacturing cost can be reduced.

It is the schematic which shows the whole structure of the sugar_chain | carbohydrate antigen extraction kit by this invention. It is the schematic which shows the detailed structure of an airtight container. It is the schematic which shows a mode when the sample collection swab is inserted in the container part of an airtight container. It is a graph which shows stability after specimen extract preparation. It is the schematic which shows the structure of the airtight container by other embodiment. It is the schematic which shows the detailed structure of the airtight container shown in FIG. It is sectional drawing which shows the side cross-section structure of the airtight container provided with the cap by other embodiment. It is the schematic which shows the structure of the airtight container which enclosed the powdery body. It is the schematic where it uses for description (1) of the usage method of the conventional group A beta hemolytic streptococcal antigen kit. It is the schematic where it uses for description (2) of the usage method of the conventional group A beta-hemolytic streptococcus antigen kit.

1 Sugar chain antigen extraction kit
2 Sample collection swab
3,20,30,50 Airtight container
6 Collection unit
7 Napped surface layer (surface)
10,21,32 cap
11,31 Container section
18,24 packing
51 Powdery body

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

(1) Whole structure of sugar chain antigen extraction kit In FIG. 1, 1 shows the sugar chain antigen extraction kit by this invention, the airtight container 3 in which airtight space is formed with the cap 10 and the container part 11, and a subject. And a sample collection swab 2 for extracting the sample to the sample extract S in the airtight container 3, and the sample extract S containing nitrous acid is enclosed in the airtight container 3 as an enclosed liquid ing.

  In this embodiment, the sugar chain antigen extraction kit 1 generates a test solution by extracting the sample collected from the subject into the sample extract S in the airtight container 3, and then a test strip determination unit (not shown). Is immersed in this test solution, and whether or not the group A β-hemolytic streptococcal antigen (detection target) is present in the test solution can be determined by the presence or absence of a line due to the antigen-antibody reaction in the determination unit. .

  Here, the sample collection swab 2 constituting the sugar chain antigen extraction kit 1 is provided with a rod-shaped shaft portion 5 having a predetermined length, and a collection portion provided at the tip of the shaft portion 5, for example, having an elliptical cross section. 6 and. The collection unit 6 is covered with a napped surface layer portion 7 in which napped bodies are densely packed in a brush shape.For example, when a certain liquid is touched, the liquid does not penetrate into the inside of the collection unit 6, and capillary action or surface The tension is applied to the napped surface layer portion 7 by tension.

  Thus, when the sample collection swab 2 wipes, for example, the pharynx, which is an inflamed part of the subject, in the collection unit 6, the sample obtained from the pharynx does not penetrate into the collection unit 6, and capillary action or surface It can be adsorbed to the napped surface layer portion 7 on the surface by tension. Further, when the sample is adsorbed on the napped surface layer portion 7 and immersed in the sample extract S in the container unit 11 in a state where the sample is adsorbed on the napped surface layer portion 7, the sample adsorbed on the napped surface layer portion 7 It can be released into S.

  Further, the sample collection swab 2 can be provided on the inner wall of the container portion 11 without applying external force by squeezing the raised surface layer portion 7 when the sample collection swab 2 is pulled out from the container portion 11. The specimen and specimen extract S staying on the napped surface layer 7 due to capillary action and surface tension can flow down along the inner wall, and the specimen and specimen extract S can be removed from the napped surface layer 7 simply by pressing It is made like that.

  On the other hand, as shown in FIG. 2, the airtight container 3 closes the opening 13 by screwing the bottle-shaped container 11 having the opening 13 at one end and the peripheral side wall of the opening 13. A cap 10 that maintains hermeticity in the container part 11 is configured, and a predetermined amount of the sample extract S is sealed in an airtight space in which the hermeticity is maintained by the container part 11 and the cap 10.

  Here, in the case of this embodiment, the specimen extract S sealed in the airtight container 3 contains nitrite for extracting the group A β-hemolytic streptococcal antigen, which is a polysaccharide antigen, from the cells. For example, by mixing two solutions of an aqueous solution of sodium nitrite and an acidic solution containing an acid such as acetic acid or hydrochloric acid, nitrous acid is generated and sealed in an airtight container 3 that maintains airtightness. A state in which nitrous acid is generated in the specimen extract S is maintained. As described above, in this airtight container 3, by keeping the specimen extract S in a state where the airtightness is maintained until the cap 10 is opened, for example, for a long period of 6 months or more, preferably 12 months or more. Over time, the nitrite-containing state is maintained, and the extraction ability of the group A β-hemolytic streptococcal antigen possessed by the specimen extract S can be maintained.

  In this embodiment, the sample extract S containing nitrous acid is a sample containing unstable and easily decomposed nitrous acid, which is generated in advance by mixing two solutions of a sodium nitrite aqueous solution and an acidic solution. Although the case where the extract S is applied has been described, the present invention is not limited to this, and if the sample extract S contains nitrous acid, the production method is not particularly limited, and other various production methods may be used. The generated specimen extract S may be applied.

  Here, in the case of this embodiment, the container part 11 is, for example, a transparent glass bottle, and the body diameter D is 7 to 10 [mm] and the total height H is 10 to 40 [mm], which is used for one inspection. An amount of the specimen extract S can be enclosed in the container part 11. Actually, since the container portion 11 is made of a glass material, the internal gas does not leak to the outside and the external gas does not enter the inside at the side wall and the bottom portion. By sealing with the cap 10, high airtightness can be maintained, and the specimen extract S can be held for a long time in a state containing nitrous acid.

  In practice, the container part 11 is formed with an opening 13 so that the collection part 6 of the specimen collection swab 2 can be inserted, and the specimen extract S in the container part 11 has a liquid height 3 [ mm] or more, and when the sample collection swab 2 is inserted into the container 11 through the opening 13, at least the tip region of the collection unit 6 of the sample collection swab 2 is immersed in the sample extract S. The specimen adsorbed on the tip region of the collection unit 6 can be extracted into the specimen extract S.

  Further, the container part 11 is formed with a male screw 15 on the peripheral side wall part of the opening part 13, and the cap 10 can be screwed onto the male screw 15. As a result, the container part 11 can maintain the airtightness in the opening part 13 by tightening the cap 10 with the packing 18 sandwiched between the opening part 13. Incidentally, in the case of this embodiment, the cap 10 has a cylindrical portion 10b hanging from the peripheral edge of the substantially disk-shaped top plate portion 10a, and an internal thread 17 is formed on the inner peripheral surface of the cylindrical portion 10b. The female screw 17 is screwed onto the male screw 15 of the part 11, so that the opening 13 of the container part 11 can be reliably closed while maintaining airtightness.

  The packing 18 provided on the back surface of the top plate portion 10a of the cap 10 is formed as a semi-rigid or soft flexible member by molding a resin material such as butyl rubber, elastomer, EVA or the like. In addition, the packing 18 is formed in a substantially disc shape in accordance with the outer shape of the back surface of the top plate portion 10a of the cap 10, and contacts the top plate portion 10a of the cap 10 and the opening portion 13 of the container portion 11, The opening 13 can be surely sealed.

  In practice, the packing 18 is preferably formed of a resin member that does not react with nitrous acid in the hermetic container 3, has low gas permeability, and does not allow gas generated in the hermetic container 3 to pass through. For example, in addition to the above-described butyl rubber, etc., other various resin materials such as silicon rubber, fluorine rubber, polysulfide rubber, nitrile rubber, acrylic rubber, and urethane rubber may be used. Further, since the packing 18 needs to maintain the hermeticity in the hermetic container 3 for a long period of time, it is desirable that the packing 18 be formed of a resin member that hardly deteriorates with time during the storage period.

Here, the packing 18 is preferably formed of a resin member that does not permeate gas such as nitric oxide generated from nitrous acid and can maintain the airtightness in the airtight container 3, and the packing 18 is formed. If the resin member is specified based on nitrogen gas whose molecule is smaller than that of nitrogen monoxide, etc., the resin member having a nitrogen gas permeability coefficient of 4.8 [ml · cm / cm ² · sec · cmHg] or less at a temperature of 25 ° C. Desirably formed, more preferably less than the nitrogen gas permeability coefficient of butyl rubber having low gas permeability, that is, a nitrogen gas permeability coefficient of 0.247 [ml · cm / cm ² · sec · cmHg] at a temperature of 25 ° C. desirable.

The nitrogen gas permeability coefficient is 1 [cm] for the test piece formed of a resin member, and the pressure difference between one side of the test piece and the other side is 1 atm (760 [mmHg]) 1 [cm ² ] shows the permeation amount of nitrogen gas at 25 [° C.] per second. By the way, the nitrogen gas permeability coefficient of butyl rubber mentioned above is "Japan Rubber Association Journal, Vol. 53 (1980) No.12. Release Date: April 16, 2008," Introductory Course for Rubber Engineers [III] Easy-to-understand physical properties of rubber (12) ”, Hiroshi Kenbishi (https://www.jstage.jst.go.jp/article/gomu1944/53/12/53_12_719/_pdf) It is said.

  As described above, the airtight container 3 is filled with the sample extract S of an amount to be used for one test in the highly airtight container part 11, and the cap 10 is sandwiched between the opening 18 and the packing 18 therebetween. By tightening, the airtightness at the opening 13 is maintained, the specimen extract S is sealed in a state completely isolated from the outside air, and the specimen is extracted in a state containing nitrous acid until the cap 10 is removed. The liquid S can be stored.

  Next, a series of operations for examining the presence or absence of the group A β-hemolytic streptococcal antigen using this sugar chain antigen extraction kit 1 will be described below. In this case, for example, the pharynx, which is an inflamed part of the subject, is wiped by the collection unit 6 of the sample collection swab 2, and the sample is adsorbed to the collection unit 6. At this time, the sample is adsorbed to the napped surface layer portion 7 on the surface by the capillary phenomenon or the surface tension without the sample soaking into the collection unit 6 of the sample collection swab 2. Then, the user removes the cap 10 from the container part 11 and opens the airtight container 3 whose airtightness has been maintained. As shown in FIG. 3, the sample collection swab 2 enters the container part 11 from the opening part 13. The sampling unit 6 is inserted, and the sampling unit 6 is immersed in the sample extract S in the container unit 11 for a predetermined time.

  Thereafter, the sample-collecting swab 2 is taken out from the container part 11, and at that time, the napping surface layer part 7 is simply pressed against the inner wall of the container part 11 without squeezing the collecting part 6 as in the prior art. The specimen or specimen extract adsorbed on the napped surface layer part 7 due to capillary action or surface tension flows down along the inner wall, and the excess specimen or specimen extract can be removed from the napped surface layer part 7. More reagent solution containing the sample in S can be left in the container part 11.

  Here, the specimen extract S in the container part 11 contains nitrous acid when the cap 10 of the airtight container 3 is opened, and when the specimen contains a group A β-hemolytic streptococcal antigen, By the action of nitrous acid, a group A β-hemolytic streptococcal antigen, which is a polysaccharide antigen in the sample, is released from the cells, and the group A β-hemolytic streptococcal antigen can be extracted from the sample.

  Finally, the test strip determination unit is immersed in the test solution in the container unit 11, and after a predetermined time has passed, the presence or absence of a line due to an antigen-antibody reaction in the determination unit is visually confirmed. Whether the group A β-hemolytic streptococcal antigen is present in the test solution can be determined.

(2) Actions and effects In the above-described configuration, in this sugar chain antigen extraction kit 1, the sample extract S containing nitrous acid is sealed in an airtight container 3 that maintains airtightness. From the time when S was sealed in the airtight container 3 to the time when the sample extract S was used for the presence or absence of group A β-hemolytic streptococcal antigen, unstable nitrous acid was included in the sample extract S. The specimen extract S can be continuously stored in the state.

  Further, in this sugar chain antigen extraction kit 1, the specimen extract S containing nitrous acid prepared and prepared in advance at an optimal mixing ratio can be sealed in the airtight container 3, so that it has been conventionally used in the medical field. Mixing two liquids of sodium nitrite aqueous solution and acidic solution that have been performed to produce a sample extract containing nitrous acid each time can be omitted, thereby reducing the burden on the user. be able to.

  In addition, the sugar chain antigen extraction kit 1 uses the sample collection swab 2 in which the sample does not penetrate into the collection unit 6 and the sample is adsorbed to the raised surface layer portion 7 by capillary action or surface tension. Therefore, the sample adsorbed on the napped surface layer portion 7 can be released to the sample extract S simply by immersing the collection portion 6 in the sample extract S in the container portion 11, and when removing the collection portion 6 from the container portion 11 Because the specimen and specimen extract adsorbed on the raised surface layer portion 7 flow down along the inner wall simply by pressing the raised surface layer section 7 against the inner wall (predetermined part) of the container section 11, more specimen extract S It can be collected in the container part 11.

  By the way, as shown in FIG. 10A, conventionally, when extracting a sample collected from a subject with a cotton swab 105 into a sample extract, in order to squeeze the sample soaked into the tip cotton ball portion 105a of the cotton swab 105, Since it was necessary to squeeze and rub the tip cotton ball 105a with your finger strongly, a flexible soft material that can be easily crushed by the gripping force of the user to ensure that this squeezing operation can be performed. The manufactured extraction tube 100 had to be used.

  As described above, the conventional extraction tube 100 is manufactured from a flexible soft material in consideration of the ironing operation. Even if a cap is provided in the opening to close the opening, unstable nitrous acid vaporizes over time, and the sample extract had A after about 24 hours from the time of generation. The ability to extract group β hemolytic streptococcal antigens cannot be achieved.

  On the other hand, in this sugar chain antigen extraction kit 1, the sample extract S is sealed by enclosing the sample extract S in a hermetic container 3 made of a hard material that has always been performed and cannot be rubbed. It prevents vaporization of nitrous acid contained in S and enables long-term storage while maintaining the extraction ability of the group A β-hemolytic streptococcal antigen possessed by the sample extract S.

  In this sugar chain antigen extraction kit 1, the sample collection swab 2 can remove the sample adsorbed on the napped surface layer portion 7 and the sample extract by simply pressing the napped surface layer portion 7 against the inner wall of the container portion 11. As a result, the conventional ironing operation was performed even when using the container part 11 which is made of a hard material such as a non-deformable glass material (hard glass) and cannot perform the ironing operation due to the gripping force of the user. The sample can be extracted into the sample extract S in the same manner as in the above, and more sample solution is left in the container part 11 without the sample solution being sucked into the sample collection swab 2. The presence or absence of group β hemolytic streptococcal antigen can be examined.

  In the case of this embodiment, since the container portion 11 is formed of a hard material such as a transparent glass bottle, not only the gripping force of the user but also an impact from the outside due to some cause during transportation is given. Even if the container part 11 itself is deformed, the container part 11 itself is not easily deformed, and the container part 11 can be kept airtight, and nitrous acid can be continuously contained in the specimen extract S until the cap 10 is opened. .

  Further, in the case of this embodiment, the container part 11 is formed of a transparent glass bottle, and the inside of the container part 11 can be visually confirmed. Therefore, the collection part 6 of the sample collection swab 2 is immersed in the sample extraction liquid S. The work can be performed while visually confirming the situation and the amount of the test solution.

  According to the above configuration, this sugar chain antigen extraction kit 1 is impossible in the past because the specimen extract S containing nitrous acid prepared in advance is sealed in the airtight container 3 that maintains airtightness. This makes it possible to store the specimen extract S in a state containing the nitrous acid for a long period of time, which eliminates the need for pre-use preparation at the medical site and prevents incorrect preparation. The manufacturing cost can be reduced by the simple structure in which only one solution is enclosed.

(3) Verification test (3-1) Preservability of specimen extract Next, seven types of commercially available group A β-hemolytic streptococcal antigen kits were prepared, and these seven types of group A β-hemolytic streptococcal antigen kits were used. It was examined how long the antigen extraction ability of each specimen extract to be used lasted. Here, as a group A β-hemolytic streptococcal antigen kit, Clear View Strep (manufactured by Sanwa Chemical Laboratories Co., Ltd.), BinxNow (manufactured by Allia Medical Co., Ltd.), Elnas (manufactured by TAF Co., Ltd.), Immunocard (Co., Ltd.) Seven types, TF Check), Stat Check Strep A (manufactured by Nichirei Bioscience), Rapid Tester (manufactured by Sekisui Medical Co., Ltd.), and Quick View (manufactured by DS Pharma Biomedical Co., Ltd.) were used.

  These seven types of group A β-hemolytic streptococcal antigen kits are all based on immunochromatography, and a sample extract is prepared at the time of use by mixing a solution containing sodium nitrite and an acidic solution such as acetic acid. A sample collected by rubbing the pharynx of a subject with a cotton swab is placed in a sample extract, and extracted, for example, for 1 minute to release polysaccharide antigens from the cells and prepare a test solution.

In this case, for these seven types of group A β-hemolytic streptococcal antigen kits, each container is mixed with two chemicals according to the dosage method of Nohsho to produce each sample extract containing nitrous acid, and immediately 5 × 10 ⁷ / ml group A β-hemolytic streptococci (Streptococcus A, Micro Detect, Inc.) 10 [μL], added to each container, left for 1-2 minutes, then each group A β-hemolytic streptococcal antigen The immunochromatographic reaction was initiated according to the kit dosage regimen. And after completion | finish of reaction time designated by the ability book of each A group (beta) hemolytic streptococcus antigen kit, when the line intensity | strength was measured with immunochromatography reader C10066 (made by Hamamatsu Photonics Co., Ltd.), the result as shown in FIG. 4 ( In FIG. 4, "0" is obtained).

Separately, for these seven types of group A β-hemolytic streptococcal antigen kits, two chemical solutions are mixed in each container according to the dosage method of the Noboru and each sample extract containing nitrous acid is generated. After leaving for 22 hours (one day), add 10 [μL] of group A β-hemolytic streptococci at 5 × 10 ⁷ cells / ml to each container and leave it for 1 to 2 minutes. The immunochromatographic reaction was started according to the dosage regimen of the antigen kit. Then, after completion of the reaction time specified in the booklet of each group A β-hemolytic streptococcal antigen kit, the line intensity was measured with an immunochromatographic reader C10066 (Hamamatsu Photonics), and the results shown in FIG. 4 (in FIG. 4) "22") was obtained.

  From the results of FIG. 4, it was confirmed that the extraction ability to extract the group A β-hemolytic streptococcal antigen by the sample extract was lost over time in all the group A β-hemolytic streptococcal antigen kits. For this reason, it can be seen that in the conventional group A β-hemolytic streptococcal antigen kit, sodium nitrite and acid must be mixed immediately before use.

  Next, using the seven types of containers shown in Table 1 below, sodium nitrite and acetic acid are added to produce a sample extract containing nitrous acid, and the sample extract is stored in each of these containers. Went.

  Specifically, in this experiment, LD polyethylene tubes (manufactured by Shin Corporation), Eppen Safe Lock micro test tubes (manufactured by Eppendorf), TP311 (PET (PolyEthylene Terephthalate)) tubes, ASONE Co., Ltd.), assist tube (Assist Co., Ltd.), glass bottle (manufactured by Nidec Rika Glass Co., Ltd., packing S-08 (butyl rubber), cap S-08 (black) (phenolic resin)), glass vial 1 (Autosampler vial + AG cap, packing (2 layers of Teflon (registered trademark) / rubber): manufactured by ASONE), Glass vial 2 (autosampler vial + AG cap, packing (2 layers of Teflon / silicon): ASONE) Made).

  In this experiment, a test membrane plan in which an anti-strept A rabbit polyclonal antibody was applied in a line form at a rate of 1 [μL / cm] to a nitrocellulose membrane (MilliPore), and an anti-strept A rabbit polyclonal antibody was colloidal in gold colloid. An immunochromatographic measurement strip was prepared by combining the labeled gold colloid bound to the conjugate pad with the conjugate conjugate pad soaked in the conjugate pad and dried.

  Then, put each sample extract into each use container, cap it and keep the inside of the use container isolated from the outside air, and to what extent each sample extract has the ability to extract antigen As a result of evaluation based on the antigen-antibody reaction using an immunochromatographic measurement strip, the results shown in Table 1 above were obtained.

In Table 1, represents when it is determined by detecting the test line visually positive "+" represents a positive determination of line of weakness strength enough to detect the test line appears barely at "+", the test line detection Negative judgments that cannot be made are indicated by “-”.

  From Table 1, it was found that the effective security period of the extraction ability of the specimen extract was different depending on each container used. Specifically, from Table 1, commercially available containers made mainly of polyethylene, PET, and polystyrene do not have the ability to extract specimen extracts for 2 months, and cannot maintain their reactivity, It was confirmed that the extraction capacity of the sample extract was maintained for a long period of 12 months or longer by using the container made of the material.

  Incidentally, from the above experiments, it was confirmed that the container 11 using a glass material is preferable in order to maintain the extraction ability of the specimen extract, but the present invention is not limited to this, for example, polyethylene, PET, Even if it is a synthetic resin material such as polystyrene, the side wall and bottom of the container part are thickened to improve the airtightness, the synthetic resin material is molded at a high density to improve the airtightness, or the airtight sheet May be adhered to the inner wall or the like of the container part to improve the airtightness in the container part, or the container part may be formed of a metal material having high airtightness.

  In other words, as long as the hermetic container 3 can maintain the hermeticity in the container part 11 until the cap 10 is opened and can maintain the extraction ability of the detection target of the specimen extract S over a long period of time, various other types You may shape | mold a container part using a material, and may apply the container part which consists of various structures. And, as these various airtight containers, by continuing to store the sample extract S while maintaining airtightness, the extraction ability of the detection target possessed by the sample extract S is at least 6 months, preferably 12 It is preferable that it can last for more than a month.

  In addition, the sample extract S is sealed in the glass bottle of Table 1 using packing of butyl rubber (manufactured by Nidec Rika Glass Co., Ltd., for packing S-08 (butyl rubber), for cap S-08 (black) (phenolic resin)). After 6 months, the cap is opened and the above-mentioned immunochromatographic strip is immersed in the sample extract S in the container, and then the immunochromatographic reader C10066-10 (Hamamatsu Photonics) is stored. Numerical value was examined for the line strength of the test line.

  The glass vial 1 shown in Table 1 using a two-layer packing of Teflon / rubber (natural rubber) and the glass vial 2 shown in Table 1 using a two-layer packing of Teflon / silicon are also described above. In the same manner as above, the sample extract S was sealed inside and stored for 6 months while maintaining an airtight state, then the cap was opened, and the above-described immunochromatographic measurement strip was immersed in the sample extract S in the container part. Thereafter, numerical values were examined for the line strength of the test line using an immunochromatographic reader C10066-10 (manufactured by Hamamatsu Photonics Co., Ltd.).

  As a result, in the glass bottle using butyl rubber packing, the line strength retention after 6 months is about 78%, while in the glass vial 1 using Teflon / rubber two-layer packing, 6 months. Later line strength retention was about 15%. Further, in the glass vial 2 using the Teflon / silicon two-layer packing, the line strength retention after 6 months was about 9%.

Therefore, in the glass bottle using the butyl rubber packing, the internal airtightness is further maintained as compared with the other glass vials 1 and 2, and the extraction ability of the detection target of the specimen extract S is higher. It was confirmed that the extractability could be maintained so that it could be used for clinical trials even 6 months after sealing. Although this has a difference in cap structure between the glass bottle and the glass vials 1 and 2, whether or not the airtightness in the airtight container 3 can be maintained depends mainly on the material of the packing covering the opening of the container part. It was confirmed that it was desirable to use butyl rubber packing in order to maintain the airtightness in the airtight container 3. Therefore, in order to maintain the extraction ability of the sample extraction liquid S that remains high for a long period of time, the nitrogen gas permeability coefficient of butyl rubber (25 [° C] is 0.247 [ml · cm / cm ² · sec · cmHg]) It was confirmed that it was most desirable to use a packing made of the following resin member.

(3-2) Sample collection swabs Next, four types of sample collection swabs were prepared, and the sample recovery rate of each sample collection swab was verified. Specifically, in this experiment, a flogged swab, which is a sample collecting swab 2 provided with a raised surface layer portion 7 described in the above-described embodiment, and a sponge swab provided with a collecting portion made of a sponge having a porous surface, Four types were prepared: a loop whose tip was bent into a loop shape and formed into an O shape, and a normal rayon swab generally called a cotton swab.

  Here, 10 [μL] of 100 [mg / ml] BSA aqueous solution was added to a glass vial (outer diameter 14 [mm], total height 30 [mm]) containing 0.7 [ml] distilled water, The absorbance (OD280 [nm]) was measured three times, the BSA extinction coefficient was set to 0.584 (0.584 = 1 mgBSA / ml), the concentration was calculated from that number, converted into the amount per glass vial, and 100 [% It was a recovery.

  Then, 10 [μL] of 100 [mg / ml] BSA aqueous solution was sucked into each of these 4 types of sample collection swabs, and the BSA aqueous solution was placed on the inner wall of a glass vial containing 0.7 [ml] distilled water. BSA was extracted and recovered by rotating the tip so that the tip was sucked 10 times, and the absorbance was measured. In addition, extraction operation was performed only with the sample collection swab as Blank, and the obtained number was subtracted and corrected from the value obtained by the BSA recovery operation from each sample collection swab. When the concentration was converted from the obtained absorbance, the recovery amount was calculated and the recovery rate was determined, the results shown in Table 2 below were obtained.

  From Table 2, the rayon swab (cotton swab) used in the conventional group A β-hemolytic streptococcal antigen kit has an extremely low recovery rate of 7.2 [%] by simply pressing the tip portion against the wall. It can be seen that it is necessary to squeeze the tip to increase the recovery rate. Here, since the airtight container 3 constituting the sugar chain antigen extraction kit 1 according to the present invention is made of a hard material such as a glass material, it is difficult to be deformed by the gripping force of the user, and the container part 11 itself The tip of the rayon swab in the container part 11 cannot be squeezed by deforming. Therefore, it is not preferable to use the rayon swab that requires the work of squeezing the tip to increase the recovery rate in the sugar chain antigen extraction kit 1 according to the above-described embodiment.

  On the other hand, the three types of sample collection swabs, Frog Swab, Sponge Swab and Loop, have a very high BSA recovery rate by simply pressing the tip against the inner wall. No need for squeezing work. Therefore, in the sugar chain antigen extraction kit 1 according to the above-described embodiment, not only the sample collection swab 2 (Frog swab) in which the napped surface layer portion 7 is provided on the surface of the collection unit 6, but also a sponge swab or loop can be used. The sample can be extracted into the sample extract S in the airtight container 3, and more sample solution can be generated without the excess sample extract S or the like being sucked into the sample collection swab.

(3-3) About the amount of the sample extract in the container Next, the amount of the sample extract S sealed in the container 11 is verified. Here, eleven kinds of hermetic containers 3 having different inner diameters of the container parts 11 were prepared, and the relation between the liquid height and the liquid amount in the container parts 11 was examined for each container part 11, as shown in Table 3 below. Results were obtained.

  Here, in the sugar chain antigen extraction kit 1, in order to extract the sample collected by the collection unit 6 of the sample collection swab 2 into the sample extraction solution S, the collection unit 6 of the sample collection swab 2 uses the sample extraction solution. It is necessary to immerse in S. In the sample collection swab 2 used in this sugar chain antigen extraction kit 1, it is assumed that the maximum bulge portion of the collection unit 6 is formed in the vicinity of about 3 [mm] from the tip of the collection unit 6. In this case, considering that the maximum bulge portion of the collection unit 6 is immersed in the sample extract S, the liquid height of the sample extract S is preferably 3 mm or more.

  Therefore, as a result of examining the liquid volume at which the liquid height of the specimen extract S was 3 [mm] or more for each of the 11 kinds of prepared container parts 11, the results shown in Table 3 were obtained. A preferable liquid amount can be determined when the container part 11 is used. In the case of the soft extraction tube 100 (FIG. 9A) that has been used conventionally, the sample extract S can be distributed and squeezed by crushing the extraction tube with a finger, but the glass according to the present invention. Although it is difficult to crush the container part 11 made of a material, if the specimen extract S having a liquid height of 3 [mm] is contained in the container part 11, the container part 11 itself can be tilted obliquely. The specimen can be extracted by substantially immersing the collection portion 6 of the specimen collection swab 2 in the specimen extract S.

  Here, in the container portion 11 made of a glass material, when the sample collection swab 2 is taken out after being immersed in the sample extract S, the sample extract S is adsorbed to the collection portion 6 of the sample collection swab 2 to efficiently squeeze the sample extract S. I can't. On the other hand, the sample collection swab 2 constituting the sugar chain antigen extraction kit 1 of the present invention has the napped surface layer portion 7 formed on the surface of the collection unit 6, and the sample extraction solution S is increased in the collection unit 6. Since the sample extract S is only held by capillary action or surface tension at the surface raised surface layer portion 7 of the surface without sucking, the amount of the sample extract S held by the sampling portion 6 is accordingly increased. It will decrease to about 50 [μL]. As a result, it is only necessary that the specimen extract S with a liquid amount of 50 to 200 [μL / test] be enclosed in the container 11 as the specimen extract S used for one test.

  The rayon swab cotton swab 105 (FIG. 9B) used in the conventional group A β-hemolytic streptococcal antigen kit has a large absorption amount of 200 [μL], and therefore the extraction tube 100 has a minimum amount of 350 [μL]. It is necessary to store the specimen extract consisting of Also, if this cotton swab 105 is extracted for a long time, or if it is strongly pressed against the side wall of the tube 100 for extraction, etc., the rayon winding of the tip cotton ball part 105a loosens and the shape collapses and swells. Tend to increase. In that case, it is necessary to further increase the amount of the specimen extract.

  In contrast, in the sugar chain antigen extraction kit 1 of the present invention, as described above, the amount of liquid retained in the collection unit 6 of the sample collection swab 2 is as small as about 50 [μL]. 50 to 200 [μL / test] sample extract S should be enclosed in an airtight container as the sample extract S used for each test, and sample extraction is better than the conventional group A β-hemolytic streptococcal antigen kit. The amount of the liquid S can be significantly reduced.

  The inner diameter shown in Table 3 above indicates the inner diameter of the bottom of the container portion 11. The opening 13 of the container part 11 is often smaller than the bottom part, but this is not a limitation, and the opening 13 is selected as the diameter that the sampling part 6 can be inserted according to the size of the sampling part of the sample collection swab. do it. For example, when the maximum diameter of the collection part 6 at the tip of the specimen collection swab 2 is about 5 [mm], the diameter of the opening 13 of the container part 11 needs to be 5 [mm] or more, more preferably 7 [ mm] or more is preferable.

(4) Other Embodiments (4-1) Structure of an Airtight Container According to Other Embodiments The present invention is not limited to the above-described embodiments, and is within the scope of the gist of the present invention. As long as various modifications can be made and the airtightness can be maintained, airtight containers having various configurations may be applied. For example, in FIG. As described above, the airtight container 20 in which the through hole 22 is provided in the top plate portion 21a of the cap 21 and the through hole 22 is closed by the packing 24 may be applied. Even in this case, in the airtight container 20, by maintaining the airtightness until the cap 21 is opened, for example, a group A of the sample extract S over a long period of 6 months or longer, preferably 12 months or longer. The ability to extract β-hemolytic streptococcal antigen can be maintained.

  In practice, the hermetic container 20 covers the through hole 22 formed in the central region of the top plate portion 21a of the cap 21, as shown in FIG. Thus, the packing 24 can be disposed on the back surface of the top plate portion 21a. In this case, the packing 24 has an outer shape matching the back surface of the top plate portion 21a, is formed in a disk shape having a predetermined thickness, and can maintain the airtightness of the through hole 22 of the cap 21. ing.

Incidentally, even in the case of this embodiment, it is desirable to form the packing 24 by a resin member similar to that of the above-described embodiment, and preferably at a temperature of 25 ° C., the nitrogen gas permeability coefficient is 4.8 [ml · cm / cm ² · The packing 24 is formed of a resin member of sec · cmHg] or less, more preferably a nitrogen gas permeation coefficient of butyl rubber having high airtightness (0.247 [ml · cm / cm ² · sec · cmHg] at 25 ° C) or less. Is desirable.

  In this cap, the cylindrical portion 21b hangs down from the peripheral edge of the top plate portion 21a, the female screw 17 is formed on the inner peripheral surface of the cylindrical portion 21b, and the female screw 17 is screwed to the male screw 15 of the container portion 11. Can do. In this airtight container 20, without removing the cap 21, the packing 24 exposed from the through hole 22 of the cap 21 is broken using, for example, the other end of the shaft portion 5 of the sample collection swab 2 (FIG. 1). The collection part 6 of the sample collection swab 2 can also be inserted into the container part 11 from the through hole 22.

  Further, as an airtight container according to another embodiment, as shown in FIG. 7, the cap 32 is not screwed to the peripheral side wall portion of the opening portion 13 of the container portion 31, and is simply fixed so as to cover it. The airtight container 30 in which the airtightness in the container part 31 is maintained may be used.

  In this case, the cap 32 includes a plug 34 fitted into the opening 13 of the container 31, a protector 35 covering the upper part of the opening 13 into which the plug 34 is fitted and the entire peripheral side wall, and a protector 35. The cover 35 is fixed to the protector 35 at an upper portion of the cover 35 and covers the protector 35 and the plug 34.

  In practice, in the case of this embodiment, the plug 34 is formed as a semi-rigid or soft flexible member by molding a resin material such as butyl rubber, elastomer, EVA, etc., and is fitted into the opening 13. As a result, the air tightness of the container part 31 can be maintained. In the case of this embodiment, the plug body 34 is fitted so that the cylindrical portion is in close contact with the inner wall of the opening portion 13, and covers the entire opening portion 13 at the upper portion, so that airtightness can be maintained. It is made like that.

  The protector 35 that covers the plug body 34 is made of an aluminum material or the like, covers the entire area from the wall 31a to the plug body 34 formed on the peripheral side wall portion of the opening section 13, and seals between the opening section 13 and the plug body 34. Has been made to improve. In the case of this embodiment, the protector 35 is formed so that the skirt portion is tightened by a tightening machine and is in close contact with the inclined fogged portion 31a, so that the sealing performance can be further improved. .

  The cover part 36 is formed with a rupture part 41 between the protrusion part 42 provided on the back surface of the top plate part 36a and the back surface, and when attached to the protector 35, an opening edge 39 of the protector 35, The fracture portion 41 is integrally molded. That is, when the cover part 36 is attached to the protector 35 and an external force upward is applied so as to be separated from the protector 35, the break part 41 integrally formed with the opening edge part 39 of the protector 35 is broken and the opening edge is broken. It is separated from the part 39 and removed from the protector 35.

  In such an airtight container 30, after removing the cover portion 36, the plug body exposed from the protector 35, for example, at the other end of the shaft portion 5 of the sample collection swab 2 without removing the protector 35 and the plug body 34. It is also possible to break the central region of 34 and insert the collection part 6 of the sample collection swab 2 into the container part 31.

  And even in such an airtight container 30, it is possible to maintain the airtightness in the container part 31 until the cap 32 is opened, for example, for 6 months or more, preferably over a long period of 12 months or more, The sample extract S can maintain the ability to extract group A β-hemolytic streptococcal antigens.

(4-2) Configuration of an airtight container containing a powder according to another embodiment In the above-described embodiment, the case where only the specimen extract S is sealed in the airtight container 3 has been described. The present invention is not limited to this, and as shown in FIG. 8 in which the same reference numerals are assigned to the corresponding parts to FIG. 1, a powdery substance (squeezing member) 51 such as a glass bead together with the specimen extract S is sealed in an airtight container 50. You may make it enclose in. Thus, when the powdery substance 51 is put in the airtight container 50 together with the specimen extract S, the collection section 6 of the specimen collection swab 2 (FIG. 1) is immersed in the specimen extract S in the container section 11. In this case, the sampling part 6 can be buried in the powder 51 and rubbed.

  Thus, in the airtight container 50 in which the powdery body 51 is placed, not only the sample collection swab 2 provided with the napped surface layer portion 7 in the collection unit 6 but also a cotton swab 105 (FIG. 9B) which is a commonly used rayon swab. Even if the tip cotton ball 105a cannot be squeezed from the outside of the container part 11 when the tip cotton ball part 105a of the cotton swab 105 is pulled out from the container part 11, the tip cotton ball part 105a is removed from the powdery body 51. By rubbing by embedding in between, the specimen that has penetrated into the tip cotton ball part 105a by the impact can be extracted into the specimen extract. That is, even with the cotton swab 105, the sample can be extracted from the collection unit 6 into the sample extract by pressing the collection unit 6 against the powder 51 (predetermined site) in the airtight container 50.

  Here, as the ironing member provided in the container portion 11 of the hermetic container 50, in addition to the glass beads described above, various other powders such as plastic beads, mineral beads such as alumina and sand, ceramic beads, and plastics. The body may be applied. Further, as another ironing member, for example, a cylindrical packing is provided in the opening 13 of the container part 11, and the tip portion of the sample collection swab is taken in and out of the cylindrical part of the cylindrical packing, so that the inside of the container part 11 Various ironing members may be applied, such as ironing the tip of the tube portion against the tip of the tube portion.In short, the ironing member that contacts the tip of the sample collection swab with the sample is provided in the container portion 11, and It is only necessary that the tip of the sample collection swab is squeezed by the squeezing member so that the sample can be efficiently extracted into the sample extract.

  By the way, as for the powdery body, after the tip part of the sample collection swab is brought into contact with the powdery body 51 in the sample extract S, the surface tension is applied when the sample collection swab is pulled out from the container part. A powdery material having a size such that the powdery material does not adhere to the tip of the sample collecting swab is preferable.

  Next, a plurality of types of powdery bodies were prepared, and it was verified how much BSA sucked by the rayon swab for pharynx as a cotton swab can be collected by each powdery body placed in the container. Here, as shown in Table 4 below, in addition to the case where the powder was not placed in the container (“without BEADS”), glass beads with a diameter of 4 [mm] (“BEADS4”) and a diameter of 3 [ mm] glass beads ("BEADS3"), 2 [mm] diameter glass beads ("BEADS2"), 1 [mm] diameter glass beads ("BEADS1"), and 0.8 [mm] diameter glass beads ("BEADS0.8") and 6 types of hard powders of 1 [mm] ceramic particles ("ceramic") were prepared.

  The glass beads “BEADS4” to “BEADS0.8” were purchased from As One Corporation. Control ("Control") is a glass vial (outer diameter 14 [mm], total height 30 [mm]) containing distilled water 0.6 [ml], 10 [mg / ml] BSA aqueous solution 100 [μL In addition, the absorbance (OD280nm) was measured three times. The BSA extinction coefficient was set to 0.584, the concentration was determined from the number, converted to the amount per glass vial (container part), and used as 100 [%] recovery.

  Without BEADS, first, 10 [mg / ml] BSA aqueous solution was inhaled by 100 [μL] to the throat rayon swab (Heiwa Medic). Next, the pharyngeal rayon swab was rotated 10 times against the inner wall of a glass vial containing 0.6 [ml] of distilled water without glass beads, and BSA was extracted into distilled water from the throat rayon swab.

  Extraction was performed 10 times with a sample-collecting swab containing no cotton BSA, and correction was performed by subtracting from the absorbance value obtained by collection as a blank. In addition, the same operation was performed for “BEADS4” to “BEADS0.8” and “ceramic”, and the recovery rate was calculated. The results shown in Table 4 were obtained.

  From Table 4, as a result of using glass beads of various particle sizes and ceramic particles, the recovery rate of BSA is 10% or less when the BSA recovery operation is performed without putting anything in the glass vial (container). On the other hand, when unreacted resistors such as glass beads and ceramic particles were placed in the glass vial, the BSA recovery rate was 79% or more, which clearly showed a high recovery efficiency. From such a result, it is a case where a rayon swab that absorbs a sample that has been used conventionally is used as a sample collection swab by putting various molded products into the container as an unreactive resistor. In addition, it was confirmed that the specimen absorbed by the rayon swab can be efficiently extracted by squeezing the rayon swab with a molded product.

  In the above-described embodiment, the case where the group A β-hemolytic streptococcal antigen is applied as the detection target is not limited to this, and various antigens may be applied as the detection target. . Further, in the sample kit 1 according to the above-described embodiment, the case where the sample collecting swab 2 that can retain and adsorb the sample on the napped surface layer portion 7 due to capillary action or surface tension has been described, but the present invention describes this. Not limited to this, a sample collection swab that allows the sample to adhere to the surface of the collection part by at least one of capillary action or surface tension may be applied.

  In the above-described embodiment, the sugar chain antigen extraction kit 1 provided with the airtight container 3 and the sample collection swab 2 has been described. However, the present invention is not limited to this, and the airtight container 3 and the sample collection swab are provided. 2 may be used as a detection kit in which an immunochromatographic test strip for detecting group A β-hemolytic streptococci is added to the sugar chain antigen extraction kit 1 provided with 2.

  Furthermore, in the above-described embodiment, the case where the airtight container 3 that maintains the airtightness in the opening by applying the packing 10 to the opening of the container 3 and tightening the cap 10 has been described. The present invention is not limited to this, and an airtight container in which a cap is directly fastened to the opening of the container without using a packing may be applied as long as the airtightness in the opening can be maintained. The cap 10 is preferably formed of a hard synthetic resin member such as a phenol resin, but may be formed of a glass material such as hard glass or other various materials. In addition, the cap may have various shapes as long as the airtightness in the container portion can be maintained. For example, the cap may be formed in a sheet shape and attached to the opening of the container portion.

  Further, in the above-described embodiment, the cap 10 that closes the opening of the container 3 and maintains the airtightness in the container 3 is detachably provided in the opening of the container 3. As described above, the present invention is not limited to this, and if the airtightness in the airtight container can be maintained, for example, a head having a body diameter smaller than the container part has a throttle part having a body diameter smaller than that of the head part and the container part. An ampoule-type airtight container integrally formed in the opening of the container portion may be applied.

  In this way, even in an ampoule-type airtight container whose head is integrally formed with the container part through the throttle part, the airtightness in the container part can be maintained, and in a state in which nitrous acid has been included, which was impossible in the past The specimen extract can be stored for a long period of time, and the same effects as those of the above-described embodiment can be obtained. In such an airtight container, during use, an external force can be applied to the head to break the throttle, and the opening of the container can be opened to the outside, and the sample collection swab can be added to the sample extract in the container. The tip can be immersed. Incidentally, as an ampoule type airtight container in which such a head is integrally formed with the container part through the throttle part, it is desirable to be formed integrally with a glass material such as hard glass, but the airtightness in the container part is preferable. May be integrally formed of various other materials.

Claims (7)

An airtight container in which a specimen extract containing nitrous acid is sealed in advance in a container part that maintains airtightness;
A collection unit for collecting a sample from a subject, and after collecting the sample by the collection unit, the collection unit is immersed in the sample extract, and the sample is extracted from the collection unit to the sample extract and a swab for specimen collection to,
The collection unit is immersed in the specimen extract in the opened airtight container,
When the sample is collected from the subject, the sample does not penetrate into the inside of the collection unit, and has a surface to which the sample is attached by at least one of capillary action or surface tension, and A sugar chain antigen extraction kit , wherein the specimen is released into the specimen extract simply by being pressed against the inner wall of the container when being taken out from the container after being immersed in the specimen extract . An airtight container in which a specimen extract containing nitrous acid is sealed in advance in a container part that maintains airtightness;
A collection unit for collecting a sample from a subject, and after collecting the sample by the collection unit, the collection unit is immersed in the sample extract, and the sample is extracted from the collection unit to the sample extract Swab for sample collection
With
The collection unit is immersed in the specimen extract in the opened airtight container,
The sample collection swab is a fluged swab provided with the collection part covered by a napped surface layer part, a sponge swab provided with the collection part made of a sponge having a porous surface, or an O-shape folded in a loop shape It is a loop comprising the sampling part formed in
A sugar chain antigen extraction kit. The airtight container, by while maintaining the airtightness continue to store the sample extract, the extraction ability of the detection object to the specimen extract has a feature that is on persistent least 6 months or more The sugar chain antigen extraction kit according to claim 1 or 2 . The sugar chain antigen extraction according to any one of claims 1 to 3, wherein the container part is formed of a hard material having airtightness that prevents gas in the container part from leaking to the outside. kit. The airtight container in the cap is tightened in between the packing in the opening of the container portion, any one of claims 1-4, characterized in that air-tightness of the opening is maintained 2. The sugar chain antigen extraction kit according to 1. To the container portion, when the sampling part of swab the specimen collection is inserted inside the container portion, of the claims 1-5, characterized in that the squeezing member hits with the sampling unit is provided The sugar chain antigen extraction kit according to any one of claims. The sugar chain antigen extraction kit according to any one of claims 1 to 6,
A detection kit comprising an immunochromatographic test strip for detecting group A β-hemolytic streptococci.

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