JP5686853B2 - Swab for collecting biological specimen, method for producing the swab, and kit using the swab - Google Patents

Description

  The present invention relates to a swab for collecting biological specimens.

  In biological examinations, particularly simple measurement examinations, it is important to efficiently collect hair, tissues, body fluids and the like necessary for the examination and to remove minute solid impurities. Conventionally, swabs (cotton swabs) have been used for specimen collection.

  Patent Document 1 describes a method in which a biological sample is collected using a sample collection device such as a sterile cotton swab, the sample is placed in a tube with a filter and filtered while being pressurized, and an immunological test method is performed. Has been.

  Patent Document 2 discloses a swab for collecting a biological specimen, which is composed of a rod having a tip covered with a hydrophilic fiber that absorbs the biological specimen, and the fiber is flocking. A swab is described, characterized in that it covers the chip in the form of a layer deposited by. Here, the flock method described in Patent Document 2 refers to directly fixing a flock produced by cutting a fiber called floc into a rod tip by electric flocking using an electrostatic field. In the flock method, if the adhesion between the rod and the fiber is insufficient, the fiber may be removed and the yield during swab production may be reduced.

  Patent Document 3 describes a method in which a biological specimen is collected using a brush-shaped swab, filtered through a sintered filter, and then subjected to an immunological test. In the method of Patent Document 3, the brush-shaped swab has a high collection efficiency of a biological specimen, but the manufacturing process may be complicated, and the yield during swab manufacturing may be reduced.

Japanese Patent Laid-Open No. 2004-028875 Special Table 2007-523663 Publication JP 2008-122372 A

  The present invention provides a swab for collecting a biological specimen, a kit using the swab, and a method for producing the swab.

  As described above, swabs are used to collect specimens in biological examinations, but conventional swabs do not necessarily have high collection efficiency and yield during swab production. Accordingly, there has been a demand for a swab having high collection efficiency of a viscous liquid biological specimen and a high yield during swab production. The present inventor fixes the raised body formed with the short fiber portion raised against the base material to the tip of the rod or the tip of the rod tip so that the short fiber of the rod tip or the tip part is difficult to be removed, and the yield at the time of swab production is increased. Found to rise. Furthermore, the present inventors have found that a sample can be efficiently collected using the swab produced in this manner, and have completed the present invention.

That is, the present invention is as follows.
[1] A swab for collecting a biological specimen comprising a rod and a raised body, wherein the raised body includes a substrate portion and a short fiber portion having the absorbability of the biological sample, and the short fiber portion is a substrate. A swab for collecting a biological specimen, which is present in the form of a brush on the surface of the part, and wherein the nap body is fixed to the rod so that the short fiber part is substantially upright on the rod surface.
[2] The swab for collecting a biological specimen according to [1], wherein the napped body base material is planar, ribbon-like, or thread-like.
[3] The swab for collecting a biological specimen according to [1] or [2], wherein the napped body is fixed in a range of 0.1 to 30 mm from the tip of the rod.
[4] The swab for collecting a biological specimen according to any one of [1] to [3], wherein the fineness of the short fibers of the napped body is 1.0 to 4.0 dtex.
[5] The swab for collecting a biological specimen according to any one of [1] to [4], wherein the length of short fibers of the napped body is 0.5 to 3 mm.
[6] The living organism according to any one of [1] to [5], wherein the short fiber of the napped body is selected from the group consisting of nylon, rayon, polyester, polyamide, carbon fiber, alginate, natural fiber, and a blend thereof. Swab for collecting biological specimens.
[7] The biological specimen according to any one of [1] to [6], wherein the rod has a structure in which a pseudo-spherical tip is formed at the tip of a rod-like body, and the napped body is fixed to the surface of the tip. Swab for collection.
[8] A step of applying an adhesive to the surface of the rod-shaped rod or the tip of the rod tip, and the surface of the rod or the tip of the rod tip comprises a base body portion and a short fiber portion having the absorbability of a biological specimen. The method for producing a swab for collecting a biological specimen according to any one of [1] to [7], wherein the short fiber portion includes a step of fixing a raised body existing in a brush shape on the surface of the base material portion.
[9] It includes a step of manufacturing a raised body by attaching short fibers to the substrate surface in a brush shape, and a step of fixing the raised body to the surface of a rod-shaped rod or a tip of a rod using an adhesive [1] A method for producing a swab for collecting a biological specimen according to any one of [7].
[10] The method for producing a swab for collecting a biological specimen according to [8] or [9], wherein the napped body is wound around a rod or a tip at the tip of the rod.
[11] A kit for detecting an object in a biological sample, including the swab for collecting a biological sample according to any one of [1] to [7].

  The swab for collecting a biological specimen of the present invention is manufactured by fixing a raised body having a short fiber portion raised against a base material to a rod or a tip at the tip of the rod. For this reason, the yield at the time of a swab manufacture improves compared with the manufacture by the flock method in which a short fiber is directly flocked to a rod. Furthermore, since the short fibers are difficult to come out and the fiber density of the short fiber portion can be fixed in a high state, the substance to be detected in the specimen can be collected with high efficiency.

It is a figure which shows the manufacturing method (the manufacturing method of the swab by an indirect flock method) of the swab using a planar napping body. It is a figure which shows the manufacturing method (manufacturing method of the swab by an indirect flock method) of the swab using a thread-like napping body. It is a figure which shows the manufacturing method (The manufacturing method of the swab by the direct flock method) of the conventional swab.

  Hereinafter, the present invention will be described in detail.

  The present invention is a swab for collecting a biological specimen, and is composed of a raised body including a short fiber that absorbs the biological specimen and a rod, and the raised body is fixed to one end of the rod. The napped body may be directly fixed to the rod, or a tip may be formed at the tip of the rod, and the napped body may be fixed on the tip. Here, the tip is a part of the rod. In the present invention, the term “rod” includes a rod on which a tip is formed and a rod on which no tip is formed.

  The shape of the rod is not particularly limited as long as it is rod-shaped or tapered, but a rod having a thickness of about 0.5 to 3 mm and a length of about 30 to 200 mm is preferably used. The rod can be made of polyethylene, vinyl chloride, nylon, polypropylene, PET (polyethylene terephthalate), ABS resin (acrylonitrile-butadiene-styrene copolymer synthetic resin), bamboo, wood, hard paper, metal, etc. . When heat treatment is performed in swab production, plastics such as polycarbonate, PET, and ABS having high heat resistance are preferably used.

  A pseudo-spherical tip may be attached to the tip of the rod, or the tip portion may be formed by deforming the rod. The tip refers to a part of the rod including a part having a larger diameter than the rod existing at one end of the rod. The chip has a convex surface with a smooth surface, and the shape thereof is preferably a spherical shape, a pseudo-spherical shape (substantially spherical shape) such as a spheroid, or a chamfered column shape. When the tip is attached to the tip of the rod, examples of the material of the tip include thread, plastic, bamboo, wood, hard paper, and metal. The tip can be attached to the tip of the rod by a method in which a thermosetting resin pseudosphere is attached to the tip and heat-cured, a method in which a flexible material such as a thread or belt is wound and molded into a predetermined shape. Alternatively, the tip of the rod may be molded by heating and melting and deforming. The surface of the chip may be provided with irregularities, grooves, and cuts for fixing the nap body.

  In the present invention, the napped body is an object including a base material portion and a short fiber portion, and the short fiber portion constituting the napped hair is present in a brush shape with respect to the base material (base), and the base material supports the short fiber portion. It has a function as a body. The substrate has a surface shape (sheet shape), a string shape, a ribbon shape, a thread shape, and the like. One end of the short fiber is attached to the base material. It is desirable that the short fiber is substantially upright with respect to the surface of the substrate. At least when the napped body is fixed to the rod or the tip of the rod, the short fiber remains substantially upright with respect to the rod surface. Exist. The term “substantially upright” means that the short fibers are not required to exist in a vertical state with respect to the substrate surface or the rod surface, but exist in an almost upright state. The presence of the short fibers in a substantially upright state with respect to the rod surface allows the biological specimen to efficiently come into contact with the short fibers when collecting the specimen, resulting in efficient collection of the biological specimen. it can. An example of a raised body is one in which a short fiber and a base material are integrated. The short fiber and the base material being integrated means, for example, a case where the base material and the short fiber are integrally formed of the same material when the napped body is manufactured. Further, as will be described later, in the fabric having a fluff (pile) such as bettin, the short fibers are projected from the surface of the fabric as the base material, and the short fiber and the base material are also integrated in such a fabric. It is called napped body. Moreover, you may manufacture a napped body by fixing a short fiber later with respect to a base material. In the present invention, the base portion of the napped body is sometimes referred to as a main body portion. In this case, the napped body has a structure in which short fibers are attached to the base portion that is the main body portion.

  The material of the substrate is not limited, and any material can be used as long as it is a material that can be fixed by wrapping around a rod in a state where short fibers are attached. For example, cloth, fiber, thread, non-woven fabric, natural resin, synthetic resin, paper, animal skin or fur can be used. Preferably, cloth, thread, non-woven fabric is used, and velor, betting, velvet, etc. are used. The shape of the substrate is not limited, and a string, ribbon, thread, surface, or sheet can be used. Alternatively, a sheet or sheet may be used and processed into an appropriate shape by cutting or the like with short fibers attached.

  Moreover, you may use elastic base materials, such as rubber | gum, for a base material. In this case, fixing by stretching the stretchable base material around the surface of the rod or the chip is preferable because the adhesion between the napped body and the rod or the chip is improved by the tension.

  The short fiber portion on the surface of the napped body can be made of a microfiber having a hollow portion, natural materials such as cotton, silk and cellulose, plastic, carbon fiber, alginate and the like. Among these, microfibers having high absorption efficiency of liquid specimens are preferable, and microfibers made of resins such as nylon, rayon, polyester, polyamide, etc. are preferably used.

  The density and length of the short fibers on the surface of the napped body are not limited, but the density per unit area is 100 or more per square centimeter, preferably 500 or more, more preferably 1000 or more, more preferably 5000 or more. Particularly preferably, the number is 10,000 or more. A higher fiber density is more preferable, for example, at 10,000 or more because the absorption efficiency of the liquid specimen is high. The fiber length of the short fiber is preferably 0.5 to 3 mm (short fiber length) from the base to the base to the short fiber tip.

  The fineness of the short fibers of the napped body is not particularly limited as long as it is hygroscopic, and can be appropriately selected according to the use of the swab. For example, when the specimen is a viscous liquid such as nasal discharge, it is preferable that the short fibers maintain a raised state even in the viscous liquid. Therefore, the short fibers are required to have a certain degree of strength, and have a fineness and a surface area that can provide a certain degree of strength. I need it. The fineness of short fibers is the weight of a single fiber, gram per linear unit length. The fineness of the short fiber is preferably 1.0 to 4.0 dtex, and preferably 1.5 to 3.0 dtex, from the viewpoint of strength, workability, bendability and the like.

  As described above, the napped body can be one in which the base material and the short fiber are integrated, but can also be manufactured by fixing the short fiber to the base material. In this case, one end of the short fiber is fixed to the base material. It is desirable that the short fibers are attached substantially upright with respect to the substrate surface. For example, short fibers may be fixed to one side of a cloth-like substrate. The method for fixing the short fibers to the base material is not limited. For example, the short fibers can be fixed to the base material by electric flocking using an electrostatic field by the flock method. In the prior art, there is a method of manufacturing a swab by directly fixing a short fiber to a rod by a flock method. In this method, the short fiber is directly fixed to the surface of the rod. On the other hand, in this invention, a short fiber is fixed to a base material by the flock method, a napped body is manufactured, and this napped body is fixed to a rod. The former conventional method is a method that should be called a direct flock method, whereas the method of the present invention can be called an indirect flock method. In this way, the short fibers can be fixed to the base material in a brush shape.

  In the conventional flocking method (direct flocking method) in which a short fiber is implanted on a rod or a base material fixed to the rod, the density of the short fiber on the rod or the chip cannot be increased. On the other hand, in the present invention, a napped body having short fiber napping is fixed and manufactured by, for example, wrapping around a rod, so that there is little detachment of short fibers during production, and the density of short fibers on the rod or chip is increased. can do. This high-density short fiber can efficiently collect a specimen.

  The short fiber portion on the surface of the base material may be oriented in one direction, and may be arranged radially in a direction substantially perpendicular to the base material shape. Moreover, the part which has not arrange | positioned the short fiber may be provided in the single side | surface or a part of a base material, an adhesive agent may be apply | coated to the part which has not arrange | positioned the short fiber, and you may adhere | attach with a rod.

  The above-mentioned napped body is fixed to the rod, for example, a planar napped body may be bonded to the tip or tip of the rod using an adhesive or the like, or a string-like, ribbon-like or thread-like napped body is attached to the rod. You may adhere | attach using an adhesive agent etc. in the state wound around the front-end | tip part or a chip | tip. At this time, an adhesive may be applied to the tip of the rod or the tip, and the raised body may be fixed thereto. Further, there may be a portion without short fibers on the surface of the napped body. For example, when short fibers are fixed to one side of a cloth-like base material, an adhesive may be applied to the back side of the base material and fixed to the rod. Furthermore, as described above, the irregularities, grooves, and cuts on the rod or chip provided for fixing the raised body may be fixed with or without an adhesive. By fixing in this manner, the short fiber portion of the napped body is arranged in a substantially upright direction toward the center of the axis of the rod or tip.

  The raised body may be fixed within a range of 0.1 to 30 mm (cotton ball length), preferably 0.5 to 20 mm from the tip of the rod. If it is this range, it will be easy to entangle the solid content in a test substance, and a solid insoluble matter can be extract | collected efficiently. The presence of the solid insoluble matter itself may cause a non-specific reaction for the subsequent test, which is not preferable, but the solid insoluble matter may contain an object to be measured. In many cases, it is preferable that many samples can be collected. Further, if the specimen is a viscous liquid such as nasal discharge, a thin film is formed and held between the short fibers by the surface tension, so that the collection efficiency is high. After the sample is collected, when the viscous fiber is recovered by washing the short fiber portion with water, the solid insoluble matter itself is captured by the short fiber and does not flow out, and the viscous liquid containing a large amount of detection object is eluted. Therefore, the short fiber of the napped body captures insoluble matter and also serves as a filter.

  As the raised body, for example, a string-like body is used. A string-like body is an object in which fibers are combined and the ends of the fibers are raised. Further examples include bettin, velvet, velor, animal fur and the like having short fiber napping. Betting is a fabric that weaves with cotton yarn, forms a portion where the yarn protrudes from the surface like a cut, and cuts the portion of the fill to make it napped. Velvet weaves two overlapping fabrics, combines a pile yarn between the two fabrics, a fabric with a knife between the fabrics, Velor cuts the pile and puts long fluff on the surface It is a fabric. Velor dough is preferably used because it absorbs liquid biological specimens well. The napped body can be produced by placing a short fiber on a base material and bonding one end of the fiber with a resin or an adhesive. Alternatively, a short fiber of synthetic fiber may be placed on a base material in a standing state, and one end of the fiber may be heat-welded.

The present invention includes a method for producing the swab.
That is, the napped body is first manufactured. The napped body can be manufactured by integrating the base material and the short fiber, or can be manufactured by fixing the short fiber to the base material. Although the fixing method of the short fiber to a base material is not limited, What is necessary is just to fix by the flock method, for example. This method may be referred to as an indirect flock manufacturing method. Subsequently, the raised body manufactured in this way is fixed to the surface of the rod-shaped rod using an adhesive or the like. By fixing in this way, the short fibers of the napped body exist in a state of being substantially upright in a brush shape with respect to the rod surface.

  FIG. 1 shows a manufacturing method using a planar nonwoven fabric (velor fabric) as the substrate 2. In FIG. 1, first, short fibers 1 are fixed to a substrate (velor fabric) 2 by a flock method to produce a raised body 3. At this time, the length of the short fiber is about 0.3 mm, and the fabric thickness is about 50 μm. As the velor fabric, for example, a synthetic fiber capable of heat welding is used. Next, the napped body 3 thus manufactured is wound around the tip 5 of the tip of the rod 4 and bonded to manufacture the swab of the present invention.

  In FIG. 2, the manufacturing method at the time of using a thread-like base material as the base material 2 is shown. A napped body 3 is manufactured by fixing microfiber fibers as short fibers 1 to a thread-like base material by a flock method. The length of the short fiber 1 of the napped body 3 obtained is about 0.3 mm. Similar to the method of FIG. 1, the napped body 3 obtained is wound around the tip 5 of the tip of the rod 4 and bonded to manufacture the swab of the present invention.

  FIG. 3 shows a swab manufacturing method according to a conventional method (direct flock method). In the conventional method, the short fiber is directly attached to the surface of the rod.

  The swab of the present invention is used as follows. In the present invention, the biological specimen refers to pharyngeal or nasal swab, pharyngeal or nasal wash, nasal aspirate, saliva, serum, stool, stool suspension, urine, culture fluid, and the like. In the swab of the present invention, the short fibers constituting the napped body are absorbable and can absorb the specimen. Further, the short fibers of the napped body are arranged in a brush shape, and the specimen can be held between the short fibers. These biological assays are used to detect the analyte contained therein. After collecting nasal discharge or pharyngeal swab from a patient using a swab, it is washed using, for example, distilled water, physiological saline, buffer solution or the like. The assay may be performed using the washing solution as a specimen sample (specimen suspension). The analyte sample is filtered in the assay device using a filtration filter provided in the assay device, or filtered outside the assay device using a filtration filter in a filtration device separate from the assay device. For example, the specimen sample is preferably filtered while applying pressure using a tube having a filtration filter at the tip. At this time, if there are many contaminants in the specimen sample, the filter is clogged, so it is necessary to pressurize at a high pressure. When a high pressure is applied to the filter, the filter is crushed or deformed in the thickness direction of the filter, but these phenomena block the flow path of the filtrate in the filter and cause the filter itself to be clogged.

  There is no particular limitation on the substance to be detected in the biological specimen collected by the swab of the present invention. For example, any substance such as protozoa, fungus, bacteria, mycoplasma, rickettsia, chlamydia, and virus can be the analyte. Any substance such as a toxin, enzyme, polypeptide, protein, sugar chain, glycoprotein, lipid, DNA, RNA or the like can be an analyte. The whole substance or a part of the substance can be the analyte. In addition, antibodies using them as antigens can also be analytes.

  Moreover, the swab of the present invention is used in a method for analyzing various components contained in a specimen. Here, the analysis method is not particularly limited. For example, observation with a microscope, observation with a sorting medium, slide latex reagent for observation of agglutination reaction, fluorescent antibody method reagent, enzyme immunoassay reagent, metabolite detection reagent, immunochromatography reagent, various methods for detecting genes and nucleic acids Etc., but any method is acceptable. That is, the swab of the present invention is a biochemical test swab for collecting a biological specimen for biochemical test. The above analysis method may be performed by a technique, by an apparatus or a kit applying the above analysis method, or by a machine such as an immunological automatic analyzer, a biochemical automatic analyzer or a PCR apparatus. Absent.

  Since the swab of the present invention can capture many liquid specimens in the short fiber portion of the nap body, it is possible to reduce the pressure during pressure filtration in the above assay, and the detection sensitivity of the detection object Can be high. Moreover, since it manufactures using the napped body which has the nap of a short fiber, the yield at the time of swab manufacture can also be improved compared with manufacture by a direct flock method.

  Furthermore, the present invention includes a kit for detecting an object to be detected in a biological specimen containing the swab. The kit includes at least the above-mentioned swab and a detection object detection reagent, and a detection apparatus detects a detection object in a biological sample collected by the swab. Examples of the detection object detection device include a detection device including a slide latex reagent, a detection device including a fluorescent antibody method reagent, a detection device including an enzyme immunoassay reagent, and a detection device including an immunochromatography reagent.

  The biological sample collection swab of the present invention is used for sample collection for detecting viruses, bacteria, and the like in biological samples and antibodies to be detected.

1 Short fiber of napped body 2 Base material of napped body (base)
3 Napped body 4 Rod 5 Tip

Claims (5)

Consisting rod and piloerection body, throat or nasal swabs, pharyngeal or nasal wash, nasal aspirate, saliva, a sampling swab biological specimen selected from the group consisting of stool, and stool suspension, the piloerection body, cord-like, comprising a short fiber portion having a base portion that is ribbon-like or filamentous absorbent of the biological specimen, the short fiber sections indirect flock method brush on the surface of the substrate portion The short fibers of the napped body have a fineness of 1.0 to 4.0 dtex, a length of 0.5 to 3 mm, a density of 100 or more per square centimeter, and the napped body is attached to the rod. A swab for collecting biological specimens in which the short fiber part is fixed so that it is almost upright on the rod surface.   2. The swab for collecting a biological specimen according to claim 1, wherein the napped body is fixed in a range of 0.1 to 30 mm from the tip of the rod. The swab for biological specimen collection according to claim 1 or 2 , wherein the short fibers of the napped body are selected from the group consisting of nylon, rayon, polyester, polyamide, carbon fiber, alginate, natural fiber, and a blend thereof. . The biological specimen collection according to any one of claims 1 to 3 , wherein the rod has a structure in which a pseudo-spherical tip is formed at a tip of a rod-like body, and a napped body is fixed to the surface of the tip. Swab for. A detection object detection kit in a biological specimen, comprising the biological specimen collection swab according to any one of claims 1 to 4 .