WO2005031342A1 - Filter holder and inspection filter unit having the same - Google Patents

Filter holder and inspection filter unit having the same Download PDF

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Publication number
WO2005031342A1
WO2005031342A1 PCT/JP2004/014565 JP2004014565W WO2005031342A1 WO 2005031342 A1 WO2005031342 A1 WO 2005031342A1 JP 2004014565 W JP2004014565 W JP 2004014565W WO 2005031342 A1 WO2005031342 A1 WO 2005031342A1
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WO
WIPO (PCT)
Prior art keywords
filter
filter holder
sample
filter unit
test
Prior art date
Application number
PCT/JP2004/014565
Other languages
French (fr)
Japanese (ja)
Inventor
Kiichiro Kobori
Kumiko Yuki
Michiko Kawamoto
Koji Ushizawa
Katsuhiro Ueda
Original Assignee
Daiichi Pure Chemicals Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Daiichi Pure Chemicals Co., Ltd. filed Critical Daiichi Pure Chemicals Co., Ltd.
Publication of WO2005031342A1 publication Critical patent/WO2005031342A1/en

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40—Concentrating samples
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40—Concentrating samples
    • G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
    • G01N2001/4088—Concentrating samples by other techniques involving separation of suspended solids filtration

Definitions

  • the present invention relates to a novel structure of a filter holder in which a filter can be mounted and a novel structure of a test filter unit in which a filter is mounted in the filter holder and a sample container is mounted.
  • INDUSTRIAL APPLICABILITY The filter holder according to the present invention and a test filter unit equipped with the filter holder are suitably used for filtering a sample liquid or a diluent thereof in a clinical test or the like.
  • pretreatment sample solution The above-mentioned sample solution or its diluted solution (hereinafter, also collectively referred to as “pretreatment sample solution”) is converted to a color-identifying substance such as an enzyme, a precious metal colloid, a colored latex, or a dye.
  • a color-identifying substance such as an enzyme, a precious metal colloid, a colored latex, or a dye.
  • the antigen in the sample and the labeled antibody are caused to react specifically to form an antigen-antibody immune complex.
  • the amount of the immune complex is measured visually or as an optical change, and qualitative measurement or quantitative measurement of the antigen in the sample is performed.
  • the influenza virus belongs to the Orthomics virus family and has a diameter of 80%. It is a globular virus with a diameter of ⁇ 120 nm, and is serologically classified into three types: type A, type B and type C. The main causes of influenza epidemic in Japan in winter are influenza A and B viruses.
  • Diagnosis includes nasal secretions, nasal swabs, and pharyngeal swabs. These samples contain mucopolysaccharides and glycoproteins present in the nasal secretions, nasal cavity, and pharynx in addition to the target virus, and often interfere directly or indirectly with virus measurement. .
  • a filter holder that has been used in the past and has a flat bottom inside (for example, the one shown in Fig. 2A) has a pre-treated sample solution (hereinafter “filtrate”) after passing through the filter. Since the direction of the flow path was not determined, counterturbulence was likely to occur, and considerable pressure was required for filtration. In addition, since many viscous mucopolysaccharides and glycoproteins are present in the sample, the pores of the filter can be easily closed, and the pressure sometimes rises. In such a case, small bubbles may be generated in the filtrate, which may cause an error in the volume of the filtrate or may make it difficult to mix with the next-stage reagent.
  • the present inventors have thought that the above problems in sample filtration for clinical examinations can be solved by improving the structure of the filter holder, and as a result of various studies and trial production, the present invention has been completed.
  • a filter holder is a device that can hold a filter in which it can be mounted.
  • a filter unit is one in which a sample container is attached to a filter holder containing a filter, and the pre-treated sample solution in the sample container can be filtered through a filter.
  • Test means a filter unit used for diagnosis.
  • the pretreatment sample solution refers to a sample solution or a diluted solution thereof
  • the filtrate refers to a pretreatment sample solution after passing through a filter. Disclosure of Invention ⁇
  • the present invention has been applied to a clinical test using a sample fluid such as blood, urine, stool, nasal fluid, sputum, or a secreted fluid collected as a sample, or a diluted solution thereof, as a sample. It is an object of the present invention to provide a filter capable of efficiently filtering a processed sample liquid and a novel structure of a filter unit for inspection equipped with a filter in the filter holder and a sample container. More specifically, the present invention reduces the resistance when filtering the pretreated sample liquid, thereby suppressing unnecessary pressure application, shortening the time required for filtration, and reducing the time required for filtration. It is an object of the present invention to provide a filter holder capable of reducing the generation of small bubbles that cause a capacity error and a structure of an inspection filter unit equipped with the filter holder.
  • the present inventors have conducted intensive studies in order to solve the above-mentioned problems, and as a result, in filtering a pretreatment sample solution such as blood, urine, stool, nasal fluid, sputum or secretion fluid collected as a sputum sample,
  • a pretreatment sample solution such as blood, urine, stool, nasal fluid, sputum or secretion fluid collected as a sputum sample
  • the present inventors have found that the filter holder and the inside of the inspection filter unit fitted with the filter holder have the following structure, whereby the filtration can be performed efficiently and the generation of small bubbles can be suppressed, and the present invention has been completed.
  • the above-mentioned problems are to be solved in the finalizer unit for inspection consisting of a filter holder and a sample container.
  • the inner wall of the discharge side after the filter mounting part of the finhole letter honoreda is basically tapered.
  • the funnel structure can be solved by providing a plurality of ribs extending toward the thin tube portion of the funnel structure in the tapered portion of the funnel structure.
  • the invention described in claim 1 of the claims has a structure in which a filter can be installed, and
  • the inner wall is formed in a funnel structure composed of a tapered part of constriction and a thin tube part from the filter interior part toward the discharge end, and the inner wall of the tapered part extends toward the thin tube part.
  • This is a filter holder with multiple ribs.
  • the invention described in claim 2 is the filter holder according to claim 1, wherein the injection-side end is formed in a structure that can be attached to the sample container.
  • the invention described in claim 3 is the filter holder according to claim 1 or 2, wherein one surface is fixed to the inner wall of the tapered portion of the funnel structure, and the other surface is The other surface is a filter holder that can support the lower surface of the filter and has another triangular plate-shaped rib having three surfaces forming a flow path connected to the thin tube portion.
  • the invention described in claim 4 is an inspection in which a filter is provided inside the filter holder according to claim 2 or 3 and a sample container is attached to an end on the injection side. Filter unit.
  • the invention according to claim 5 is the test filter unit according to claim 4, wherein the filter holder and the sample container are detachable.
  • the invention described in claim 6 is the test filter unit according to claim 4 or 5, wherein the sample container has a flange portion for preventing rolling.
  • the invention described in claim 7 is the test filter unit according to any one of claims 4 to 6, wherein the sample container is made of a plastic material, and can be deformed by pressing with a finger.
  • the invention described in claim 8 filters at least one sample solution selected from blood, urine, stool, nasal fluid, sputum, or secretion fluid collected as a sub-sample or a diluted solution thereof.
  • the invention described in claim 9 is a diagnostic method for influenza virus infection.
  • the invention described in claim 10 is the test filter unit according to any one of claims 4 to 9, which is incorporated in a diagnostic kit as a diagnostic device for the presence or absence of influenza virus infection.
  • the filter holder Since the filter holder according to the present invention has the above-described structure, the filter holder is provided inside, and the filter holder is mounted on the sample container and used as a test filter unit. It has a funnel structure composed of a tapered part and a thin tube part, and has a plurality of ribs extending toward the thin tube part on the inner wall of the tapered part, so that the flow path of the filtrate can be cut off. Since the filtrate flows smoothly, no opposing turbulence occurs, and the filtration can be performed efficiently.
  • the detection filter unit according to the present invention has a low resistance at the time of filtration, and can perform filtration easily and quickly, and thus can reduce the filtration time.
  • the application of excessive pressure is suppressed, and small bubbles are less likely to be generated, thereby greatly improving difficulties in operability such as reducing errors in filtrate volume.
  • the test filter unit equipped with the filter in the filter holder according to the present invention and mounted on the sample container can easily perform the filtration operation when the sample container is pressed with fingers and filtered while applying pressure. Since it can be performed, there is little difference between individuals, and it is most suitable to be incorporated into a simple diagnostic kit for examining and diagnosing the presence or absence of influenza infection.
  • the filter holder according to the present invention when incorporated into a diagnostic kit, is used for filtering a pretreated sample solution and reacting it with a labeled antibody solution, and for filtering the reaction solution and then dropping it on a test device.
  • This is extremely useful because it can be applied to two times.
  • anyone can easily-reliably perform filtration, thereby greatly improving the accuracy of diagnosis / diagnosis of the diagnostic kit.
  • the inspection filter unit Because it can be applied to the filtration operation of various samples, it can be used for clinical examinations, especially for nasal fluid, nasal aspirate, sputum, or secretory fluid collected as a sputum sample from the nares, nasal cavity, pharynx, nasopharynx, etc. It is useful in inspection using such as. INDUSTRIAL APPLICABILITY
  • the present invention can be applied to filtration of a sample solution such as blood, urine, stool, nasal fluid, sputum or secretion fluid collected as a sput sample, or a diluted solution thereof.
  • FIG. 1 (1) is a plan view of a filter holder according to Embodiment 1 of the present invention
  • FIG. 1 (2) is a view in which a filter is mounted on the filter holder of (1). It is sectional drawing of a state.
  • FIG. 2 is an explanatory view of the structure of the filter holder used in Test Examples 1 and 2 of the present invention.
  • FIG. 3 is an explanatory diagram of a method of configuring the test filter unit of the present invention by attaching the filter holder of the present invention to the sample container.
  • reference numeral 1 denotes a filter holder
  • 11 denotes a funnel structure portion of the filter holder
  • 111 denotes a tapered portion of the funnel structure portion
  • II 2 denotes a thin tube portion of the funnel structure portion 11.
  • Reference numeral 12 denotes a sample holding container mounting portion of the filter holder
  • 13 denotes a filter interior portion of the filter holder
  • 14 denotes a support portion for fitting the filter holder 1 to another device, for example, a sample holding container.
  • 2 is a filter
  • 3 indicates lip.
  • A is a conventional filter holder having a bottom plane structure without ribs
  • B is a filter holder having a conventional bottom plane structure with eight ribs
  • C is a filter holder.
  • 8 is a filter holder provided with eight ribs 3 in the funnel structure of the present invention.
  • X is a sample container
  • Y is a fill
  • Z indicates a filter unit for inspection combining these.
  • the filter holder of the present invention needs to have a structure capable of securely mounting and holding the filter.
  • the side through which the liquid to be filtered has passed through the filter is referred to as the discharge side
  • the side into which the liquid flows into the filter is referred to as the injection side.
  • the end of the filter holder on the injection side is not particularly limited, but has a structure that can be attached to the sample container.For example, a constricted screw is provided, and the sample container is attached and deformed by hand. It is preferable to form it so that it does not come off easily even when it is done.
  • the end on the discharge side of the filter holder is formed in a funnel structure composed of a tapered portion and a thin tube portion.
  • the filter may be installed inside the tapered part of the funnel structure. The point is that the structure is such that the liquid to be filtered can pass through the filter and then pass through the tapered portion.
  • the inclination angle of the taper can be arbitrarily designed according to the properties of the liquid to be filtered.
  • a plurality of ribs extending toward the narrow tube portion are provided on the inner wall of the tapered portion of the filter holder according to the present invention.
  • the ribs of the tapered portion are arranged radially with respect to the center point of the funnel structure, but are fixed to the inner wall independently of each other without being connected at the center point. It extends toward the capillary. By providing such a lip, a divided flow path toward the tip of the funnel structure is formed.
  • the number of ribs is not particularly limited, but is 3 or more, preferably about 4 to 12 ribs, and more preferably about 6 to 8 ribs.
  • the size of the rib when the inner diameter of the filter holder is 6.6 mm, the triangular plate-shaped rib of Example 1 described below is used, and The length of the surface supporting the filter is about 2.8 mm, and the length of the surface forming the flow path of the filtrate is about 2.4 mm. That is, it is preferable that a flow path having a diameter that is close to the inner diameter of the thin tube portion but slightly larger than that is created.
  • the number, width, size (height), shape, and the like of the ribs may be arbitrarily designed in accordance with the properties of the liquid to be filtered and the size of the filter holder.
  • the material of the sample container of the present invention can be appropriately deformed by pressurization with fingers, and there is no particular limitation as long as the material and structure can be appropriately pressurized when the sample is filtered by the deformation.
  • plastic materials such as polyethylene, polypropylene, and polystyrene, particularly polyethylene are preferably used.
  • the flexural modulus of the plastic material used for the sample container may be appropriately adjusted by a known method.
  • the sample container is cylindrical, it is preferable that the sample container has a flange for preventing rolling.
  • a member generally used as a filter cloth or filter paper such as high-density polyethylene polymer filter cloth, glass fiber filter paper, or cellulose filter paper, may be used. No problem.
  • FIG. 1 shows the structure of a filter holder 1 provided with eight ribs.
  • (1) of FIG. 1 is a plan view of the filter holder 1
  • (2) of FIG. 1 is a cross-sectional view of a state where a filter is mounted on the filter holder of (1).
  • the filter holder 1 shown in (2) of FIG. 1 is supplied with the pretreatment sample liquid from above (“injection side” in the present invention) above (2) of FIG. Filter through retained filter 2
  • the filtrate is sent below (2) in FIG. 1 (the “discharge side” in the present invention). That is, the filter holder 1, in addition to the filter interior portion I 3, and a container mounting section 1 2 and the funnel structure portion 11 which is fitted removably to the discharge port of the sample container (not shown).
  • the funnel structure 11 of the filter holder 1 has a tapered portion 111 formed in a tapered shape immediately inward from the end of the filter interior portion 13 and a thin tube portion 112 formed in a thin straight tube. It consists of:
  • Reference numeral 14 denotes a support unit for fitting the filter holder 1 to another device, for example, a sample container.
  • each rib 3 has its side on the injection side contacting and supporting the lower surface of the filter 2 attached to the filter interior part 13, and the side on the discharge side is located at the inlet of the narrow tube part 112. It has been reached. That is, the eight ribs 3 3 ′ form eight flow paths through which the filtrate passes through the capillary 112.
  • the pretreatment sample liquid discharged from the sample container by deforming and pressing the sample container (not shown) with the fingers passes through the space between the sample container mounting section 12 of the filter holder 1 and enters the filter interior section 13.
  • the filter reaches the filter 2 (consisting of one or several sheets) and passes through it, it reaches the tapered part 111 of the inner constriction constituting the funnel structure. Flow through the flow path formed by 3 ⁇ 3 ⁇ '.
  • the filtrate has a tapered portion 111 formed in a tapered shape with a constriction, and the flow is directed by the ribs 3, 3. I do. Therefore, a large pressure is not required when filtering the pretreated sample liquid, and almost no counter-turbulence or small bubbles are generated in the filtrate.
  • the filtrate is discharged smoothly out of the filter holder 1 through the thin tube portion 112.
  • FIG. 2 is an explanatory diagram showing a state where a filter is mounted on the filter holder used in Test Examples 1 and 2.
  • a filter A holder with a conventional bottom plane structure without ribs As shown in Fig. 2, a filter A holder with a conventional bottom plane structure without ribs, a filter holder B with a conventional bottom plane structure with eight ribs, and a funnel structure of the present invention with eight sheets
  • the filter holder C the one in Example 1 provided with the ribs of the above, without attaching any filter, each was fitted with a sample container with the same shape whose bottom was cut off. 2 mL of the saccharose solution was added at a time, and the time required for 2 mL of the liquid to spontaneously fall was measured five times from the moment when the liquid began to flow out of the outlet of the discharge-side capillary portion.
  • the mounting area of the filter mounting portion of each filter holder and the inner diameter of the narrow tube portion on the discharge side are all the same. (Note that in Fig. 2, A, B, and C are shown with filters installed.)
  • FIG. 3 is an explanatory diagram of a method of configuring the test filter unit of the present invention by attaching the filter holder of the present invention to a sample container.
  • test filter unit used in Test Example 2 and the same samples as in Test Example 2 (saline and pre-treated sample liquids 4 to 6 (all nasal discharge)
  • testers D and E Two persons filtered each sample and confirmed the appearance of small bubbles.
  • Judgment criteria + + There is a small bubble (covering the surface),
  • the filter holder according to the present invention and the test filter unit equipped with the filter holder can be applied to the filtration operation of various specimens. Therefore, clinical tests, especially blood, urine, stool, and nasal fluid are performed. , Sputum, or secretion fluid collected as a sub-sample can be tested efficiently and reliably.
  • Various viruses, including influenza virus It is extremely useful as a simple and quick means to check for infection, determine pregnancy, and check for cancer.

Abstract

A filter holder used for clinical inspection and capable of efficiently filtrating a specimen liquid or its diluted liquid and an inspection filter unit formed by fitting a filter and a specimen storage container to the filter holder. The filter holder is formed such that the application of a pressure more than necessary thereto can be suppressed by reducing resistance produced when the specimen liquid for pretreatment is filtrated, a time required for filtration can be shortened, and the occurrence of small bubbles causing the error of the capacity of the filtered liquid can be reduced, and the filter can be installed therein. In the filter holder, an inner wall is formed in a funnel structure having an inwardly narrowed tapered part and a thin tube part formed starting at the filter internally mounted part to the discharge side end part, a plurality of ribs extending to the thin tube part are formed on the inner wall of the tapered part, and desirably the filling side end part is formed so as to be fitted to the specimen storage container. In the inspection filter unit, the filter holder is installed, and the specimen storage container is fitted to the filling side end part.

Description

明細書 フィルターホルダーとそれを装着した検査用フィルターュニッ ト 技術分野  Description Filter holder and filter unit for inspection equipped with it
本発明は、 フィルターを内装できるフィルターホルダーの新規な構造と そのフィルターホルダーにフィルターを内装し、 検体収容容器を装着した 検査用フィルターュニッ トの新規な構造に関する。 本発明 に係るフィルタ 一ホルダーとそれを装着した検査用フィルターュニッ トは、 臨床検査など において、 検体液又はその希釈液を濾過するのに好適に用 Vヽられる。 背景技術  The present invention relates to a novel structure of a filter holder in which a filter can be mounted and a novel structure of a test filter unit in which a filter is mounted in the filter holder and a sample container is mounted. INDUSTRIAL APPLICABILITY The filter holder according to the present invention and a test filter unit equipped with the filter holder are suitably used for filtering a sample liquid or a diluent thereof in a clinical test or the like. Background art
臨床検査では、 血液、 尿、 便、 鼻汁液、 痰、 或いはスヮ ブ検体と して収 集された分泌液などの種々の検体について、 これらに含まれる特定の抗原 を抗原抗体反応を利用して検出する免疫学的な検査方法が広く用いられて いる。 その一般的な方法は、 およそ以下のとおりである。  In clinical tests, specific antigens contained in blood, urine, stool, nasal fluid, sputum, or secreted liquid collected as sub-samples are used for specific antigens contained in these samples using an antigen-antibody reaction. Immunological testing methods for detection by detection are widely used. The general method is as follows.
( 1 ) 上記のような検体液又はその希釈した液 （以下、 これらを併せて 「 前処理検体液」 ともいう。 ） を、 酵素、 貴金属コロイ ド、 着色ラテックス 、 色素などの呈色識別物質で抗体を標識した標識抗体と接 虫させる。  (1) The above-mentioned sample solution or its diluted solution (hereinafter, also collectively referred to as “pretreatment sample solution”) is converted to a color-identifying substance such as an enzyme, a precious metal colloid, a colored latex, or a dye. Contact the antibody with the labeled antibody.
( 2 ) この前処理検体液と標識抗体の接触により、 検体中 の抗原と標識抗 体とを特異的に反応させて、 抗原抗体の免疫複合体を形成させる。  (2) By contacting the pretreated sample solution with the labeled antibody, the antigen in the sample and the labeled antibody are caused to react specifically to form an antigen-antibody immune complex.
( 3 ) その免疫複合体の量を、 目視によるか又は光学的な変化と して測定 し、 検体中の抗原の定性測定又は定量測定をおこなう。  (3) The amount of the immune complex is measured visually or as an optical change, and qualitative measurement or quantitative measurement of the antigen in the sample is performed.
上記のような検査方法を応用して、 ウィルス感染の有無 の確認、 妊娠判 定、 ガン疾患の罹病確認などを簡便かつ迅速に検査するた めの種々の簡易 診断キッ トが開発され、 市販されている。 その一例として、 インブルエン ザウィルスの感染の有無を診断する方法について説明する。  By applying the above-mentioned test methods, various simple diagnostic kits have been developed and marketed for simple and rapid testing of virus infection, pregnancy, cancer disease, etc. ing. As an example, a method for diagnosing the presence or absence of infection with the inbleenza virus will be described.
インフルエンザウイルスは、 オルソミ ク ソウィルス科に属する直径 8 0 〜 1 2 0 n mの球状ウィルスであり、 血清学的に A型 ' B型 . C型の 3つ の型に分類される。 日本において冬季にィンフルェンザが流行する原因と なっているのは、 主に A型と B型のインフルエンザウイルスである。 The influenza virus belongs to the Orthomics virus family and has a diameter of 80%. It is a globular virus with a diameter of ~ 120 nm, and is serologically classified into three types: type A, type B and type C. The main causes of influenza epidemic in Japan in winter are influenza A and B viruses.
インフルエンザに対して、 従来は、 抗生物質ゃ抗炎症剤などを用いた対 症療法がおこなわれてきた。 しかし、 近年、 抗ウィルス性の医薬品が適用 可能となったことから、 その治療や感染防止の観点上、 できるだけ早期に 適切な治療薬を選択し、 患者に投与することが必要となっている。 こう し た背景により、 インフルエンザウイルスの感染の有無を診断できる試薬キ ッ トの実用化が急速に進み、 各社により E L I S A (enzyme-linked immuno sorbent assay) をベースにした簡易型の診断キッ ト （試薬キッ ト） が開発 され、 市販されている。  Conventionally, symptomatic treatment with influenza antibiotics and anti-inflammatory drugs has been used for influenza. However, in recent years, since antiviral drugs have become applicable, it is necessary to select an appropriate therapeutic drug as early as possible and administer it to patients from the viewpoint of treatment and prevention of infection. Against this background, the commercialization of reagent kits capable of diagnosing the presence or absence of influenza virus infection has rapidly progressed, and each company has developed a simple diagnostic kit (reagent kit) based on ELISA (enzyme-linked immuno sorbent assay). Kit) has been developed and is commercially available.
こう した診断キッ トの使用方法の一例と して、 本発明者らが従前に開発 した診断キッ トの操作手順を示すと、 およそ以下のとおりである。  As an example of the use of such a diagnostic kit, the operation procedure of the diagnostic kit developed by the present inventors previously is roughly as follows.
( 1 ) あらかじめ一定量の検体希釈用の希釈液が入った検体収容容器に検 体を採取した綿棒を入れて検体収容容器を指で押しながら上下に数回しご き、 綿球内の検体をよく絞り 出す。 攪拌後、 再度綿球を絞りながら綿棒を 引き抜き、 前処理検体液を得た。 この前処理検体液の入った検体収容容器 に、 フィルターを内装してあるフィルターホルダ一 (フィルターを内装 · 保持する器具） を装着する。  (1) Place the swab with the sample collected in a sample container containing a certain amount of diluent for sample dilution in advance, and push the sample container with your finger up and down several times to remove the sample in the cotton ball. Squeeze well. After stirring, the cotton swab was pulled out while squeezing the cotton ball again to obtain a pretreated sample solution. Attach the filter holder (the instrument that holds and holds the filter) containing the filter to the sample container that contains the pretreated sample liquid.
( 2 ) 別の、 カラ （空） の検体収容容器に標識抗体液の一定量を入れて、 これに （ 1 ) の前処理検体液の全量を滴下し、 新しいフィルターホルダー を装着して 5〜 6回転倒させて混和した後、 室温に 5分ほど放置し、 これ を反応液とする。  (2) Put a fixed amount of the labeled antibody solution into another empty sample container, drop the whole amount of the pre-processed sample solution in (1), attach a new filter holder, and After inverting 6 times to mix, let stand at room temperature for about 5 minutes, and use this as the reaction solution.
( 3 ) この反応液をテス トデバイスの楕円孔の一定ラインまで （約 5 0 0 L) 滴下し、 反応液が楕円孔内の反応膜を通過し、 反応膜上から反応液 がなくなるのを待つ。  (3) This reaction solution was dropped to a certain line (approximately 500 L) in the oval hole of the test device, and the reaction solution passed through the reaction film in the oval hole, and the reaction solution disappeared from the reaction film. wait.
( 4 ) 洗浄液を同様に楕円孔の一定ラインまで （約 5 0 0 1 滴下し、 楕円孔の反応膜上から洗浄液がなくなるのを待つ。 ( 5 ) 洗浄液が膜上からなくなったら、 テス トデパイス上の所定の位置に 出現する赤紫色の部位により判定する。 (4) Similarly, drop the washing solution to a certain line of the elliptical hole (approximately 5001) and wait for the washing solution to disappear from the reaction film in the elliptical hole. (5) When the cleaning liquid is removed from the film, the determination is made based on the purple-red portion that appears at a predetermined position on the test device.
このよ う な簡易診断キッ トを用いて、 イ ンフルエンザの型を鑑別 . 診断 する際に、 測定対象となる検体と しては、 鼻汁、 鼻腔拭い液、 咽頭拭い液 などがある。 これらの検体中には、 目的とするウィルスの他に鼻汁、 鼻腔 、 咽頭に存在するムコ多糖、 糖蛋白などが含有されており、 しばしばウイ ルスの測定を直接又は間接的に妨害することがある。  When a simple diagnosis kit is used to determine the type of influenza. Diagnosis includes nasal secretions, nasal swabs, and pharyngeal swabs. These samples contain mucopolysaccharides and glycoproteins present in the nasal secretions, nasal cavity, and pharynx in addition to the target virus, and often interfere directly or indirectly with virus measurement. .
そのため、 臨床検査においては、 従来から用いられている内部底辺が平 面状のフィルターホルダー （例えば、 図 2の Aのもの） では、 フィルター を通過した後の前処理検体液 （以下 「濾過液」 という。 ） の流路の方向付 けがなされていないので、 対向乱流が生じやすく、 濾過にはかなりの圧力 が必要であった。 しかも、 検体中には粘性の高いムコ多糖や糖蛋白が多く 存在するので、 フィルターの孔を塞ぎやすくなり 、 さらに圧力が上がって しまう場合があった。 そのような際には、 濾過液に小泡が発生して、 濾過 液容量に誤差を生じたり、 次段階の試薬との混合が困難となるなどの事態 に至る場合があった。  For this reason, in clinical tests, a filter holder that has been used in the past and has a flat bottom inside (for example, the one shown in Fig. 2A) has a pre-treated sample solution (hereinafter “filtrate”) after passing through the filter. Since the direction of the flow path was not determined, counterturbulence was likely to occur, and considerable pressure was required for filtration. In addition, since many viscous mucopolysaccharides and glycoproteins are present in the sample, the pores of the filter can be easily closed, and the pressure sometimes rises. In such a case, small bubbles may be generated in the filtrate, which may cause an error in the volume of the filtrate or may make it difficult to mix with the next-stage reagent.
本発明者らは、 臨床検査の検体濾過における上記の問題点をフィルター ホルダーの構造を改良することによって解決できるのではないかと考え、 種々研究 '試作の結果、 本発明を完成するに至った。  The present inventors have thought that the above problems in sample filtration for clinical examinations can be solved by improving the structure of the filter holder, and as a result of various studies and trial production, the present invention has been completed.
本発明の全説明において、 フィルターホルダーとは、 フィルターをその 内部に装着することができ、 これを保持できる器具のことである。 また、 フィルターュニッ トとは、 フィルターを内装したフィルターホルダーに検 体収容容器を装着してあり、 検体収容容器内の前処理検体液をブイルター を通して濾過できる状態のものをいい、 検査用フィルターュニッ トとは、 検査 '診断に用いるためのフィルターユニッ トのことをいう。 さらに、 本 発明の全説明において、 前処理検体液とは、 検体液又はその希釈した液の ことをいい、 濾過液とは、 フィルターを通過した後の前処理検体液のこと をいう。 発明の開示 · In the entire description of the present invention, a filter holder is a device that can hold a filter in which it can be mounted. In addition, a filter unit is one in which a sample container is attached to a filter holder containing a filter, and the pre-treated sample solution in the sample container can be filtered through a filter. Test means a filter unit used for diagnosis. Further, in the entire description of the present invention, the pretreatment sample solution refers to a sample solution or a diluted solution thereof, and the filtrate refers to a pretreatment sample solution after passing through a filter. Disclosure of Invention ·
本発明は、 上記の状況に鑑み、 検体として、 血液、 尿、 便、 鼻汁液、 痰 又はスヮプ検体と して収集された分泌液などの検体液又はその希釈した液 を用いる臨床検査において、 前処理検体液を効率よく濾過できるフィルタ 一ホルダー及ぴそのフィルターホルダーにフィルターを内装し、 検体収容 容器を装着した検查用フィルターュニッ トの新規な構造を提供することを 課題とする。 より具体的には、 本発明は、 前処理検体液を濾過する際の抵 抗を小さくすることによ 、 必要以上の圧力のかかり を抑え、 濾過に要す る時間を短縮すると共に、 濾過液容量の誤差要因となる小泡の発生を軽減 できるフィルターホルダーとそれを装着した検査用フィルターユニッ トの 構造を提供することを課題とするものである。  In view of the above circumstances, the present invention has been applied to a clinical test using a sample fluid such as blood, urine, stool, nasal fluid, sputum, or a secreted fluid collected as a sample, or a diluted solution thereof, as a sample. It is an object of the present invention to provide a filter capable of efficiently filtering a processed sample liquid and a novel structure of a filter unit for inspection equipped with a filter in the filter holder and a sample container. More specifically, the present invention reduces the resistance when filtering the pretreated sample liquid, thereby suppressing unnecessary pressure application, shortening the time required for filtration, and reducing the time required for filtration. It is an object of the present invention to provide a filter holder capable of reducing the generation of small bubbles that cause a capacity error and a structure of an inspection filter unit equipped with the filter holder.
上記の課題は、 フロースルー法を利用したメンブランィムノアツセィに よる A型 · B型ィンフルェンザ測定試薬のように、 同一メンプラン上で同 時にウィルスの有無を測定するに当たって、 迅速かつ正確で特異的な判定 をおこなう上で重要な要因となっている。  The above-mentioned issues are rapid, accurate, and unique in measuring the presence or absence of virus on the same membrane at the same time, such as the type A and type B influenza assays using membrane immunoassay using the flow-through method. This is an important factor in making a proper judgment.
本発明者らは、 上記の課題を解決するために鋭意検討した結果、 血液、 尿、 便、 鼻汁液、 痰或いはスヮプ検体として収集された分泌液などの前処 理検体液を濾過するに当たり、 フィルターホルダーとそれを装着した検査 用フィルターュニッ トの内部を以下の構造にすることによって、 効率的に 濾過することができ、 かつ、 小泡の発生も抑止できることを見いだし、 本 発明を完成した。  The present inventors have conducted intensive studies in order to solve the above-mentioned problems, and as a result, in filtering a pretreatment sample solution such as blood, urine, stool, nasal fluid, sputum or secretion fluid collected as a sputum sample, The present inventors have found that the filter holder and the inside of the inspection filter unit fitted with the filter holder have the following structure, whereby the filtration can be performed efficiently and the generation of small bubbles can be suppressed, and the present invention has been completed.
上記の課題は、 フィルターホルダーと検体収容容器からなる検査用フィ ノレターユニッ トにおいて、 基本的には、 （ 1 ) フイノレターホノレダ一のブイ ルター装着部以降の吐出側の内壁をテーパー状部と細管部とで構成する漏 斗構造と し、 （ 2 ) その漏斗構造のテーパー状部に、 漏斗構造の細管部に 向かって伸びる複数のリブを設けることによって解決できる。  The above-mentioned problems are to be solved in the finalizer unit for inspection consisting of a filter holder and a sample container. (1) The inner wall of the discharge side after the filter mounting part of the finhole letter honoreda is basically tapered. (2) The funnel structure can be solved by providing a plurality of ribs extending toward the thin tube portion of the funnel structure in the tapered portion of the funnel structure.
すなわち、 上記の課題を解決するための本発明のうち、 特許請求の範囲 の請求項 1 に記載する発明は、 フィルターを内装できる構造であり、 かつ 、 フィルター内装部から吐出側の端部に向かって内壁を内窄まりのテーパ 一状部と細管部とで構成する漏斗構造に形成すると共に、 テーパー状部の 内壁には細管部に向かって伸びる複数のリブを設けてあるフィルターホル ダーである。 That is, of the present invention for solving the above-mentioned problems, the invention described in claim 1 of the claims has a structure in which a filter can be installed, and The inner wall is formed in a funnel structure composed of a tapered part of constriction and a thin tube part from the filter interior part toward the discharge end, and the inner wall of the tapered part extends toward the thin tube part. This is a filter holder with multiple ribs.
本発明のうち、 同請求項 2に記載する発明は、 請求項 1 に記載のフィル ターホルダーにおいて、 注入側の端部を検体収容容器に装着可能な構造に 形成してあるフィルターホルダーである。  Of the present invention, the invention described in claim 2 is the filter holder according to claim 1, wherein the injection-side end is formed in a structure that can be attached to the sample container.
本発明のうち、 同請求項 3に記载する発明は、 請求項 1又は 2に記载の フィルターホルダーにおいて、 一面は漏斗構造のテーパー状部の内壁に固 着してあり、 他の一面はフィルターの下面を支持可能であり、 さらに他の 一面は細管部に連なる流路を形成する 3つの面を有する三角板状のリブを 複数個設けてあるフィルターホルダーである。  Among the present invention, the invention described in claim 3 is the filter holder according to claim 1 or 2, wherein one surface is fixed to the inner wall of the tapered portion of the funnel structure, and the other surface is The other surface is a filter holder that can support the lower surface of the filter and has another triangular plate-shaped rib having three surfaces forming a flow path connected to the thin tube portion.
本発明のうち、 同請求項 4に記載する発明は、 請求項 2又は 3に記載の フィルターホルダーにフィルターを内装し、 かつ、 その注入側の端部に検 体収容容器を装着してある検査用フィルターュニッ トである。  Of the present invention, the invention described in claim 4 is an inspection in which a filter is provided inside the filter holder according to claim 2 or 3 and a sample container is attached to an end on the injection side. Filter unit.
また、 同請求項 5に記載する発明は、 フィルターホルダーと検体収容容 器が着脱自在である請求項 4に記載の検査用フィルターュニッ トである。  The invention according to claim 5 is the test filter unit according to claim 4, wherein the filter holder and the sample container are detachable.
さらに、 同請求項 6に記載する発明は、 検体収容容器が転がり防止のた めの鍔部を有する請求項 4又は 5に記載の検査用フィルターュニッ トであ る。  The invention described in claim 6 is the test filter unit according to claim 4 or 5, wherein the sample container has a flange portion for preventing rolling.
さらに、 同請求項 7に記载する発明は、 検体収容容器がプラスチック材 からなり、 手指による加圧で変形が可能である請求項 4から 6のいずれか に記載の検査用フィルターュニッ トである。  Further, the invention described in claim 7 is the test filter unit according to any one of claims 4 to 6, wherein the sample container is made of a plastic material, and can be deformed by pressing with a finger.
さらに、 同請求項 8に記載する発明は、 少なく とも、 血液、 尿、 便、 鼻 汁液、 痰、 或いはスヮブ検体として収集された分泌液から選ばれる 1つの 検体液又はその希釈した液を濾過するために用いる請求項 4から 7のいず れかに記載の検査用フィルターュニッ トである。  In addition, the invention described in claim 8 filters at least one sample solution selected from blood, urine, stool, nasal fluid, sputum, or secretion fluid collected as a sub-sample or a diluted solution thereof. An inspection filter unit according to any one of claims 4 to 7, which is used for inspection.
同請求項 9に記載する発明は、 ィンフルェンザウィルス感染の有無の診 断に用いる請求項 4から 8のいずれかに記載の検査用フィルターユニッ ト である。 The invention described in claim 9 is a diagnostic method for influenza virus infection. An inspection filter unit according to any one of claims 4 to 8, which is used for cutting.
また、 同請求項 1 0に記載する発明は、 イ ンフルエンザウイルス感染の 有無の診断用器具として診断キッ トに組み込まれている請求項 4から 9の いずれかに記載の検査用フィルターュニッ トである。  The invention described in claim 10 is the test filter unit according to any one of claims 4 to 9, which is incorporated in a diagnostic kit as a diagnostic device for the presence or absence of influenza virus infection.
本発明に係るフィルターホルダーは、 上記の構造であるから、 フィルタ 一を内装して、 これを検体収容容器に装着して検査用フィルターュニッ ト と して使用すると、 フィルターホルダーの吐出側の端部をテーパー状部と 細管部とで構成する漏斗構造にしてあると共にテーパー状部の内壁には細 管部に向かって伸びる複数のリブを設けてあるので、 濾過液の流路を分断 することができ、 濾過液がスムーズに流れるので、 対向乱流を生じること がなく、 濾過を効率的におこなうことができる。  Since the filter holder according to the present invention has the above-described structure, the filter holder is provided inside, and the filter holder is mounted on the sample container and used as a test filter unit. It has a funnel structure composed of a tapered part and a thin tube part, and has a plurality of ribs extending toward the thin tube part on the inner wall of the tapered part, so that the flow path of the filtrate can be cut off. Since the filtrate flows smoothly, no opposing turbulence occurs, and the filtration can be performed efficiently.
そのため、 本発明に係る検查用フィルターユニッ トは、 濾過の際の抵抗 が小さく なり、 容易かつ迅速に濾過をおこなうことができ、 したがって、 濾過時間を短縮できる。 また、 必要以上の圧力のかかりが抑えられ、 小泡 が発生しにく くなるので、 濾過液容量の誤差を軽減できるなど、 操作性の 難点を大きく改善できる。 しかも、 本発明に係るフィルターホルダーにフ ィルターを内装して検体収容容器に装着した検査用フィルターュニッ トは 、 検体収容容器を手指で押して加圧しながら濾過をする場合に、 濾過の操 作を容易におこなうことができるので、 個人差が生じにく く、 ィンフルェ ンザ感染の有無を検査 ，診断する簡易な診断キッ トに組み込んで用いるの に最適である。  Therefore, the detection filter unit according to the present invention has a low resistance at the time of filtration, and can perform filtration easily and quickly, and thus can reduce the filtration time. In addition, the application of excessive pressure is suppressed, and small bubbles are less likely to be generated, thereby greatly improving difficulties in operability such as reducing errors in filtrate volume. Moreover, the test filter unit equipped with the filter in the filter holder according to the present invention and mounted on the sample container can easily perform the filtration operation when the sample container is pressed with fingers and filtered while applying pressure. Since it can be performed, there is little difference between individuals, and it is most suitable to be incorporated into a simple diagnostic kit for examining and diagnosing the presence or absence of influenza infection.
その上、 本発明に係るフィルターホルダーは、 診断キッ トに組み込んだ とき、 前処理検体液を濾過してから標識抗体液と反応させる際とその反応 液を濾過してからテス トデパイスに滴下する際の 2回について応用できる のできわめて有用である。 また、 これを用いることによって誰でも容易 - 確実に濾過することができ、 診断キッ トの検查 *診断の精度を大きくアツ プすることができる。 さらに、 本発明に係る検査用フィルターュニッ トは 、 種々の検体の濾過操作に適用できることから、 臨床検査、 特に、 鼻孔、 鼻腔、 咽頭、 鼻咽頭などを由来とする鼻汁液、 鼻汁吸引液、 痰、 或いはス ヮプ検体として収集された分泌液などを用いる検査において有用である。 本発明は、 血液、 尿、 便、 鼻汁液、 痰或いはスヮプ検体と して収集され た分泌液などの検体液又はその希釈した液などの濾過に適用できる。 特に 、 鼻汁液、 去痰或いはスヮプ検体として収集された分泌液などの前処理検 体液を使用してヒ トインフルエンザ A型ウィルス又はヒ トイ ンフルエンザ B型ウィルスの存在を検出し、 かつ鑑別するための方法及ぴそのための試 薬キッ トに適用できる。 図面の簡単な説明 . 図 1の （ 1 ) は、 本発明の実施例 1のフィルターホルダーの平面図であ り、 図 1の （ 2 ) は、 ( 1 ) のフィルターホルダーにフィルターを装着し た状態の断面図である。 また、 図 2は、 本発明の試験例 1〜 2で使用する フィルターホルダーの構造の説明図である。 また、 図 3は、 検体収容容器 に本発明のフィルターホルダーを取り付けて、 本発明の検査用フィルター ュニッ トを構成する方法の説明図である。 In addition, the filter holder according to the present invention, when incorporated into a diagnostic kit, is used for filtering a pretreated sample solution and reacting it with a labeled antibody solution, and for filtering the reaction solution and then dropping it on a test device. This is extremely useful because it can be applied to two times. In addition, by using this, anyone can easily-reliably perform filtration, thereby greatly improving the accuracy of diagnosis / diagnosis of the diagnostic kit. Further, the inspection filter unit according to the present invention Because it can be applied to the filtration operation of various samples, it can be used for clinical examinations, especially for nasal fluid, nasal aspirate, sputum, or secretory fluid collected as a sputum sample from the nares, nasal cavity, pharynx, nasopharynx, etc. It is useful in inspection using such as. INDUSTRIAL APPLICABILITY The present invention can be applied to filtration of a sample solution such as blood, urine, stool, nasal fluid, sputum or secretion fluid collected as a sput sample, or a diluted solution thereof. In particular, a method for detecting and differentiating the presence of human influenza A virus or human fluenza B virus using a pre-treated test fluid such as nasal fluid, expectorant or secretory fluid collected as a sputum sample. Applicable to reagent kits for this purpose. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 (1) is a plan view of a filter holder according to Embodiment 1 of the present invention, and FIG. 1 (2) is a view in which a filter is mounted on the filter holder of (1). It is sectional drawing of a state. FIG. 2 is an explanatory view of the structure of the filter holder used in Test Examples 1 and 2 of the present invention. FIG. 3 is an explanatory diagram of a method of configuring the test filter unit of the present invention by attaching the filter holder of the present invention to the sample container.
図 1の符号について説明すると、 1はフィルターホルダーであり、 11は フィルターホルダー 1 の漏斗構造部、 111は漏斗構造部 11のテーパー状部 、 I I 2は漏斗構造部 1 1の細管部である。 また、 12はフィルターホルダー 1 の検体収容容器装着部、 13はフィルターホルダー 1 のフィルター内装部、 1 4はフィルターホルダー 1を他の器具、 例えば検体収容容器に嵌着するため の支持部である。 また、 2はフィルターであり、 3はリプを示す。 1, reference numeral 1 denotes a filter holder, 11 denotes a funnel structure portion of the filter holder 1, 111 denotes a tapered portion of the funnel structure portion 11, and II 2 denotes a thin tube portion of the funnel structure portion 11. Reference numeral 12 denotes a sample holding container mounting portion of the filter holder 1, 13 denotes a filter interior portion of the filter holder 1, and 14 denotes a support portion for fitting the filter holder 1 to another device, for example, a sample holding container. In addition, 2 is a filter, and 3 indicates lip.
図 2の符号について説明すると、 Aは、 従来の底辺平面構造でリブを設 けていないフィルターホルダー、 Bは、 従来の底辺平面構造のものにリブ 3を 8枚設けたフィルターホルダー、 Cは、 本発明の漏斗構造にしてリブ 3を 8枚設けたフィルターホルダーである。  Referring to the reference numerals in FIG. 2, A is a conventional filter holder having a bottom plane structure without ribs, B is a filter holder having a conventional bottom plane structure with eight ribs 3, and C is a filter holder. 8 is a filter holder provided with eight ribs 3 in the funnel structure of the present invention.
また、 図 3 の符号について説明すると、 Xは検体収容容器、 Yはフィル ターホルダー、 Zはこれらを組み合わせた検查用フィルターュニッ トを示 す。 発明を実施するための最良の形態 To explain the reference numerals in FIG. 3, X is a sample container, and Y is a fill. ホ ル ダ ー, Z indicates a filter unit for inspection combining these. BEST MODE FOR CARRYING OUT THE INVENTION
本発明のフィルターホルダーは、 当然のことであるが、 フィルターを確 実に内装し、 保持できる構造であることが必要である。 なお、 本発明のフ ィルターホルダーの全説明において、 フィルターを内装した内壁の部分を 中心にして、 濾過する液がフィルターを通過した側を吐出側といい、 フィ ルターに流入する側を注入側と称する。 フィルターホルダーの注入側の端 部は、 特に限定はないが、 検体収容容器に装着できる構造にし、 例えば、 くびれゃネジ状などを設け、 検体収容容器を装着して手指により変形させ るなど加圧したときでも容易に外れないように形成するのが好ましい。 ま た、 フィルターホルダーの吐出側の端部は、 テーパー状部と細管部とで構 成する漏斗構造に形成する。 漏斗構造のテーパー状部の途中にフィルター を内装する構造にしても差し支えない。 要は、 濾過する液がフィルターを 通過した後、 続いてテーパー状部を通過できる構造にすればよい。 テーパ 一の傾斜角度などは濾過する液の性状に合わせて任意に設計することで差 し支えない。  As a matter of course, the filter holder of the present invention needs to have a structure capable of securely mounting and holding the filter. In the description of the filter holder of the present invention, the side through which the liquid to be filtered has passed through the filter is referred to as the discharge side, and the side into which the liquid flows into the filter is referred to as the injection side. Name. The end of the filter holder on the injection side is not particularly limited, but has a structure that can be attached to the sample container.For example, a constricted screw is provided, and the sample container is attached and deformed by hand. It is preferable to form it so that it does not come off easily even when it is done. Further, the end on the discharge side of the filter holder is formed in a funnel structure composed of a tapered portion and a thin tube portion. The filter may be installed inside the tapered part of the funnel structure. The point is that the structure is such that the liquid to be filtered can pass through the filter and then pass through the tapered portion. The inclination angle of the taper can be arbitrarily designed according to the properties of the liquid to be filtered.
本発明に係るフィルターホルダーのテーパー状部の内壁には、 細管部に 向かって伸びる複数のリブを設ける。 別の表現で説明すると、 テーパー状 部のリブは、 漏斗構造の中心点を基準と して放射状に配置されているが、 中心点で結合することなく、 互いに独立して内壁に固着されていて、 細管 部に向かって伸びている。 このようなリプを設けることによって、 漏斗構 造の先端部に向かう分断した流路が形成される。  A plurality of ribs extending toward the narrow tube portion are provided on the inner wall of the tapered portion of the filter holder according to the present invention. In other words, the ribs of the tapered portion are arranged radially with respect to the center point of the funnel structure, but are fixed to the inner wall independently of each other without being connected at the center point. It extends toward the capillary. By providing such a lip, a divided flow path toward the tip of the funnel structure is formed.
本発明において、 リブの本数は、 特に限定はないが、 3本以上、 好まし くは 4本から 1 2本程度、 さらに好ましくは 6本から 8本程度である。 ま た、 リブの大きさについて一例を挙げると、 フィルターホルダーの内径が 6 . 6 m mのとき、 後記する実施例 1の三角板状のリブを用いると して、 フィルターを支持する面の長さは 2 . 8 m m程度、 濾過液の流路を形成す る面の長さは 2 . 4 m m程度として、 細管部に至る口径 1 . O m m程度の 流路、 すなわち、 細管部の内径に近似するが、 それに比べてやや大きい口 径の流路が作られるようにするのが好ましい。 しかしながら、 本発明では 、 リブの数や幅、 大きさ （高さ） 、 形状などは、 濾過する液の性状やブイ ルターホルダーのサイズに合わせて任意に設計することで差し支えない。 本発明の検体収容容器の材質は、 手指による加圧で適度に変形させるこ とができ、 その変形によって、 検体を濾過する際に適度に加圧できる材質 及ぴ構造であれば特に制限はないが、 好ましくはポリエチレン、 ポリプロ ピレン、 ポリスチレンなどのプラスチック材、 特にポリエチレンが好まし く用いられる。 検体収容容器に用いるプラスチック材の曲げ弾性率は、 公 知の方法で適宜調整して差し支えない。 なお、 検体収容容器が円筒形の場 合には、 転がりを防止するための鍔部を有することが好ましい。 In the present invention, the number of ribs is not particularly limited, but is 3 or more, preferably about 4 to 12 ribs, and more preferably about 6 to 8 ribs. Also, as an example of the size of the rib, when the inner diameter of the filter holder is 6.6 mm, the triangular plate-shaped rib of Example 1 described below is used, and The length of the surface supporting the filter is about 2.8 mm, and the length of the surface forming the flow path of the filtrate is about 2.4 mm. That is, it is preferable that a flow path having a diameter that is close to the inner diameter of the thin tube portion but slightly larger than that is created. However, in the present invention, the number, width, size (height), shape, and the like of the ribs may be arbitrarily designed in accordance with the properties of the liquid to be filtered and the size of the filter holder. The material of the sample container of the present invention can be appropriately deformed by pressurization with fingers, and there is no particular limitation as long as the material and structure can be appropriately pressurized when the sample is filtered by the deformation. However, plastic materials such as polyethylene, polypropylene, and polystyrene, particularly polyethylene are preferably used. The flexural modulus of the plastic material used for the sample container may be appropriately adjusted by a known method. When the sample container is cylindrical, it is preferable that the sample container has a flange for preventing rolling.
なお、 本発明で用いるフィルターの材質には特に制限はなく、 高密度ポ リエチレン重合体濾布、 ガラス繊維系濾紙、 セルロース系濾紙などの一般 に濾布又は濾紙として使用されている部材を用いて差し支えない。 実施例  There is no particular limitation on the material of the filter used in the present invention, and a member generally used as a filter cloth or filter paper, such as high-density polyethylene polymer filter cloth, glass fiber filter paper, or cellulose filter paper, may be used. No problem. Example
以下、 本発明を実施例によってさらに説明する。  Hereinafter, the present invention will be further described with reference to Examples.
(実施例 1 )  (Example 1)
< 8枚のリブを設けたフィルターホルダーの構造例 >  <Example of filter holder structure with 8 ribs>
本発明に係るフィルターホルダーの構造の一例と して、 図 1 に 8枚のリ ブを設けたフィルターホルダー 1 の構造を示す。 図 1 の （ 1 ) は、 フィル ターホルダー 1の平面図、 図 1の （ 2 ) は、 （ 1 ) のフィルターホルダー にフィルターを装着した状態の断面図である。  As an example of the structure of the filter holder according to the present invention, FIG. 1 shows the structure of a filter holder 1 provided with eight ribs. (1) of FIG. 1 is a plan view of the filter holder 1, and (2) of FIG. 1 is a cross-sectional view of a state where a filter is mounted on the filter holder of (1).
図 1の （ 2 ) に示すフィルターホルダー 1は、 図 1の （ 2 ) の上方 （本 発明でいう 「注入側」 ） から前処理検体液を送り込まれ、 ほぼ中央のブイ ルター内装部 13に内装 .保持されているフィルター 2を通過させて濾過し 、 図 1の （ 2 ) の下方 （本発明でいう 「吐出側」 ） へ濾過液を送り出すも のである。 すなわち、 フィルターホルダー 1は、 フィルター内装部 I 3の他 に、 検体収容容器 （図示せず） の吐出口に着脱自在に嵌着する容器装着部 1 2と漏斗構造部 11とを有する。 また、 フィルターホルダー 1の漏斗構造部 11 は、 フィルター内装部 13の端部から直ちに内窄ま り のテーパー状に形成し てあるテーパー状部 1 11 と細い直管に形成してある細管部 112 とで構成さ れている。 なお、 14は、 フィルターホルダー 1 を他の器具、 例えば検体収 容容器に嵌着するための支持部である。 The filter holder 1 shown in (2) of FIG. 1 is supplied with the pretreatment sample liquid from above (“injection side” in the present invention) above (2) of FIG. Filter through retained filter 2 The filtrate is sent below (2) in FIG. 1 (the “discharge side” in the present invention). That is, the filter holder 1, in addition to the filter interior portion I 3, and a container mounting section 1 2 and the funnel structure portion 11 which is fitted removably to the discharge port of the sample container (not shown). Further, the funnel structure 11 of the filter holder 1 has a tapered portion 111 formed in a tapered shape immediately inward from the end of the filter interior portion 13 and a thin tube portion 112 formed in a thin straight tube. It consists of: Reference numeral 14 denotes a support unit for fitting the filter holder 1 to another device, for example, a sample container.
フィルターホルダー 1のテーパー状部 111 の内壁には、 図 1の （ 1 ) と ( 2 ) に示すとおり、 薄い三角板状の 8枚のリブ 3 · 3 · ' がそれぞれ均 等の間隔を保って固着してある。 それぞれのリブ 3は、 その注入側の側面 がフィルター内装部 13に装着されているフィルター 2の下面に接してこれ を支持するようにしてあり、 また、 吐出側の側面は細管部 112 の入口に至 るようにしてある。 すなわち、 8枚のリブ 3 · 3 · ' によって濾過液が細 管部 112 に通ずる 8個の流路が形成されるようにしてある。  As shown in (1) and (2) in Fig. 1, eight thin triangular ribs 3.3 are fixed to the inner wall of the tapered part 111 of the filter holder 1 at equal intervals. I have. Each rib 3 has its side on the injection side contacting and supporting the lower surface of the filter 2 attached to the filter interior part 13, and the side on the discharge side is located at the inlet of the narrow tube part 112. It has been reached. That is, the eight ribs 3 3 ′ form eight flow paths through which the filtrate passes through the capillary 112.
次に、 上記の構成を有するフィルターホルダー 1 を用いて、 前処理検体 液を濾過する際の作用について説明する。 図示しない検体収容容器を手指 で変形させて加圧することによって検体収容容器から吐出されてきた前処 理検体液は、 フィルターホルダー 1の検体収容容器装着部 12の間を通って フィルター内装部 13に内装 ·保持されているフィルター 2 ( 1枚ないし数 枚で構成してある。 ） に達し、 これを通過した濾過液が漏斗構造を構成す る内窄まりのテーパー状部 111 に至ると、 リブ 3 · 3 · ' によって形成さ れる流路を流過する。 このとき、 濾過液は、 テーパー状部 111 が内窄ま り のテーパー状に形成されていると共に、 リブ 3 · 3 · · によって流れを方 向付けられ、 8個の流路に振り分けられて流下する。 そのため、 前処理検 体液を濾過する際、 大きな圧力を要せず、 濾過液に対向乱流や小泡を生ず ることもほとんどない。 濾過液は細管部 112 を通ってスムーズにフィルタ 一ホルダー 1の外へ吐出される。 試験例 Next, the operation when filtering the pretreatment sample liquid using the filter holder 1 having the above configuration will be described. The pretreatment sample liquid discharged from the sample container by deforming and pressing the sample container (not shown) with the fingers passes through the space between the sample container mounting section 12 of the filter holder 1 and enters the filter interior section 13. When the filter reaches the filter 2 (consisting of one or several sheets) and passes through it, it reaches the tapered part 111 of the inner constriction constituting the funnel structure. Flow through the flow path formed by 3 · 3 · '. At this time, the filtrate has a tapered portion 111 formed in a tapered shape with a constriction, and the flow is directed by the ribs 3, 3. I do. Therefore, a large pressure is not required when filtering the pretreated sample liquid, and almost no counter-turbulence or small bubbles are generated in the filtrate. The filtrate is discharged smoothly out of the filter holder 1 through the thin tube portion 112. Test example
以下、 本発明を試験例に基づいてさらに詳細に説明する。  Hereinafter, the present invention will be described in more detail based on test examples.
(試験例 1 )  (Test Example 1)
<濾過液の通過時間確認試験 >  <Test for checking the passage time of filtrate>
( 1 ) 試験方法  (1) Test method
図 2は、 試験例 1及ぴ 2で使用するフィルターホルダーにフィルターを 装着した状態の説明図である。  FIG. 2 is an explanatory diagram showing a state where a filter is mounted on the filter holder used in Test Examples 1 and 2.
図 2に示すように、 従来の底辺平面構造でリブを設けていないフィルタ 一ホルダー A、 従来の底辺平面構造のものにリブを 8枚設けたフィルター ホルダー B、 本発明の漏斗構造にして 8枚のリブを設けたフィルターホル ダー C (実施例 1 のもの） について、 いずれもフィルターを付けないで、 それぞれに底部を切除した同形の検体収容容器を装着し、 その中に粘性を 有する 5 0 %サッカロース溶液 2 m Lを一度に添加し、 吐出側の細管部の 出口から液が出始めた瞬間から、 該液 2 m Lが自然落下するのに要する時 間を 5回にわたって測定した。 なお、 各フィルターホルダーのフィルター を装着する部位の装着面積及ぴ吐出側の細管部の内径は、 いずれも同一で ある。 （なお、 図 2では、 A · B · Cとも、 フィルターを装着した状態を 図示している。 ）  As shown in Fig. 2, a filter A holder with a conventional bottom plane structure without ribs, a filter holder B with a conventional bottom plane structure with eight ribs, and a funnel structure of the present invention with eight sheets For the filter holder C (the one in Example 1) provided with the ribs of the above, without attaching any filter, each was fitted with a sample container with the same shape whose bottom was cut off. 2 mL of the saccharose solution was added at a time, and the time required for 2 mL of the liquid to spontaneously fall was measured five times from the moment when the liquid began to flow out of the outlet of the discharge-side capillary portion. The mounting area of the filter mounting portion of each filter holder and the inner diameter of the narrow tube portion on the discharge side are all the same. (Note that in Fig. 2, A, B, and C are shown with filters installed.)
( 2 ) 試験結果  (2) Test results
試験結果は、 表 1に示すとおりである。  The test results are as shown in Table 1.
( 3 ) 所見  (3) Findings
表 1から、 濾過液の通過時間が最も短いのは、 本発明に係る 「漏斗構造 にして 8枚のリブを設けたフィルターホルダー（：」 であった。 すなわち、 本発明に係るフィルターホルダー Cが濾過液を最もスムーズに流下できる ことが確認できた。 また、 従来の 「底辺平面構造のフィルターホルダー」 にリブを設けただけでは、 濾過液の通過時間は全く短縮できないことも確 pj > れに o N =1 N = 2 N = 3 N=4 N = 5 平均 From Table 1, the shortest passage time of the filtrate was the “filter holder (:) having the funnel structure and provided with eight ribs” according to the present invention. It has been confirmed that the filtrate can flow down most smoothly, and that simply adding ribs to the conventional “filter base with a flat bottom structure” cannot at all reduce the passage time of the filtrate. o N = 1 N = 2 N = 3 N = 4 N = 5 Average
A.従来品 19 21 22 22 22 21.2 A. Conventional product 19 21 22 22 22 21.2
B.従来品 +リブ 26 24 26 26 26 25.6 B. Conventional product + rib 26 24 26 26 26 25.6
C.本発明品 19 18 18 18 18 18.2 C. Invention product 19 18 18 18 18 18.2
(単位:秒 2ml) (Unit: 2ml per second)
(試験例 2 ) (Test Example 2)
<濾過液の吐出しゃすさの確認試験 > <Confirmation test of filtration fluid discharge>
( 1 ) 試験方法  (1) Test method
図 3は、 検体収容容器に本発明のフィルターホルダーを取り付けて、 本 発明の検查用フィルターュニッ トを構成する方法の説明図である。  FIG. 3 is an explanatory diagram of a method of configuring the test filter unit of the present invention by attaching the filter holder of the present invention to a sample container.
試験例 1で用いたフィルターホルダー A (従来口口口） 1 2個とフィルター ホルダー C (本発明品） 1 2個を用意し、 どれにも同一のガラス繊維性フ ィルター及び多孔質の高密度ポリエチレン重合体濾布を装着した。 試験者 は A . B · Cの 3名であるため、 それぞれのフィルターホルダーを 3つに 分け、 試験者ごとに、 フィルターホルダー A (従来品） とフィルターホル ダー C (本発明品） に対して、 生理食塩水及ぴ前処理検体液 1〜 3 (いず れも鼻汁） 各 2 m Lを別々に収容してある 4個の同一形状の検体収容容器 を装着した。 この状態の検査用フィルターユニッ ト （図 3 ) を用いて A · B · Cの 3名が各前処理検体液を濾過して、 吐出しやすさ （押し出しやす さ） について試験をおこなった。  Prepare 12 filter holders A (conventional mouth and mouth) used in Test Example 1 and 12 filter holders C (the present invention), and use the same glass fiber filter and porous high density. A polyethylene polymer filter cloth was attached. Since there are three testers, A, B and C, each filter holder is divided into three parts, and each tester is assigned to filter holder A (conventional product) and filter holder C (product of the present invention). Physiological saline and pre-treated sample liquids 1 to 3 (all of which were nasal discharge) were fitted with four sample containers of the same shape, each containing 2 mL each. Using the test filter unit in this state (Fig. 3), three persons A, B, and C filtered each pretreatment sample liquid and performed tests for ease of ejection (ease of extrusion).
( 2 ) 試験結果  (2) Test results
試験結果は、 表 2に示すとおりである。  The test results are shown in Table 2.
( 3 ) 所見  (3) Findings
表 2から、 従来品のフィルターホルダー Aを使用した検査用フィルター ュニッ トでは、 3名の試験者中のいずれもが検体希釈液を押し出すのは困 難であると判定した場合があり、 使いにくいことが確認された。 これに対 して、 本発明品のフィルターホルダー Cを用いた検査用フィルターュニッ トでは、 生理食塩水及ぴ前処理検体液 1 〜 3の全てについて各試験眷とも 押し出しが容易であるか又は非常に容易であると判定しており、 きわめて 使いやすいことが確認された。 From Table 2, it is difficult for any of the three testers to push out the sample diluent with the test filter unit using the conventional filter holder A. In some cases, it was determined to be difficult, and it was confirmed that it was difficult to use. On the other hand, in the test filter unit using the filter holder C of the present invention, it is easy or very easy to extrude all of the physiological saline and the pretreated sample liquids 1 to 3 in each test. It was determined to be easy, and it was confirmed that it was extremely easy to use.
表 2 Table 2
Figure imgf000015_0001
Figure imgf000015_0001
判定基準 ◎:非常に容易、〇:容易、 普通、 X：困難  Judgment criteria ◎: very easy, △: easy, normal, X: difficult
(試験例 3 ) . (Test Example 3).
<小泡の発生状況の確認試験 > <Test for confirming the occurrence of small bubbles>
( 1 ) 試験方法  (1) Test method
試験例 2で用いた検査用フィルターュニッ トを使用し、 試験例 2と同様 の検体 （生理食塩水及ぴ前処理検体液 4〜 6 (いずれも鼻汁） ) を用いて 、 試験者 D · Eの 2名が各検体を濾過して、 小泡の出現の状況につレヽて確 認した。  Using the test filter unit used in Test Example 2 and the same samples as in Test Example 2 (saline and pre-treated sample liquids 4 to 6 (all nasal discharge)), testers D and E Two persons filtered each sample and confirmed the appearance of small bubbles.
( 2 ) 試験結果  (2) Test results
試験結果は、 表 3に示すとおりである。  The test results are shown in Table 3.
( 3 ) 所見  (3) Findings
表 3から、 前処理検体液 4〜 6を濾過した場合、 従来品のフィルターホ ルダーを用いた検査用フィルターュニッ トでは、 2名の試験者とも/ J、泡の 発生が有る （ 1例を除く） と判定した。 さらに検体を含まない生理食塩水 を濾過した場合にも試験者 Dでは小泡が認められ、 従来品では小泡出現の 頻度が髙いことが確認された。 これに対して、 本発明品のフィルターホル ダーを用いた検査用フィルターュニッ トでは、 2名の試験者とも小泡の発 生が認められない （ 1例を除く） と判定した。 これらの結果から、 本発明 品を用いると小泡が出現しにく く、 試験者の手技の差 小さく なることが 確認された。 According to Table 3, when the pretreatment sample solutions 4 to 6 were filtered, the test filter unit using the conventional filter holder showed that both testers / J It was determined that there was an occurrence (except for one case). Furthermore, even when physiological saline containing no sample was filtered, small bubbles were observed in Tester D, and it was confirmed that the frequency of appearance of small bubbles was high in the conventional product. On the other hand, in the test filter unit using the filter holder of the present invention, it was determined that no small bubbles were generated in any of the two testers (except for one case). From these results, it was confirmed that when the product of the present invention was used, small bubbles were unlikely to appear, and the difference in the procedure of the tester was reduced.
表 3 Table 3
Figure imgf000016_0001
判定基準 + +：小泡有り（表面を覆う状況）、
Figure imgf000016_0001
Judgment criteria + +: There is a small bubble (covering the surface),
+：わずかに有り（小胞の塊が認められる）  +: Slightly present (vesicle clusters are observed)
土：数個点在、 一：小泡無し  Soil: several spots, one: no bubble
産業上の利用可能性 Industrial applicability
以上、 詳細に説明するとおり、 本発明に係るフィルターホルダー及びそ れを装着した検査用フィルターュニッ トは、 種々の検体の濾過操作に適用 できることから、 臨床検査、 特に、 血液、 尿、 便、 鼻汁液、 痰、 或いはス ヮブ検体と して収集された分泌液などを用いる検査を効率的かつ確実にお こなう こ とができるので、 ィ ンフルェンザウィルスを fまじめとする各種の ウィルス感染の有無の確認、 妊娠の判定、 ガン疾患の罹病確認などを簡便 にして迅速かつ確実に検査する手段としてきわめて有用である。  As described above in detail, the filter holder according to the present invention and the test filter unit equipped with the filter holder can be applied to the filtration operation of various specimens. Therefore, clinical tests, especially blood, urine, stool, and nasal fluid are performed. , Sputum, or secretion fluid collected as a sub-sample can be tested efficiently and reliably. Various viruses, including influenza virus, It is extremely useful as a simple and quick means to check for infection, determine pregnancy, and check for cancer.

Claims

請求の範囲 The scope of the claims
1 . フィルターを内装できる構造であり、 かつ、 フィルター内装部から吐 出側の端部に向かって内壁を内窄まりのテーパー伏部と細管部とで構成す る漏斗構造に形成すると共に、 テーパー状部の内壁には細管部に向かって 伸びる複数のリブを設けてあるフィルターホルダー。 1. The filter can be fitted inside, and the inner wall is formed into a funnel structure consisting of a tapered part of constriction and a narrow tube part from the filter inside part toward the end on the discharge side. A filter holder that has a plurality of ribs that extend toward the narrow tube on the inner wall of the tube.
2 . 請求項 1 に記載のフィルターホルダーにおいて、 注入側の端部を検体 収容容器に装着可能な構造に形成してあるフィルタ一ホルダー。  2. The filter holder according to claim 1, wherein an end on the injection side is formed in a structure that can be attached to a sample container.
3 . 請求項 1又は 2に記載のフィルターホルダー ίこおいて、 一面は漏斗構 造のテーパー状部の内壁に固着してあり、 他の一面はフィルターの下面を 支持可能であり、 さらに他の一面は細管部に連なる流路を形成する 3つの 面を有する三角板状のリブを複数個設けてあるフィ ルターホルダー。  3. The filter holder according to claim 1 or 2, wherein one surface is fixed to the inner wall of the tapered portion of the funnel structure, the other surface is capable of supporting the lower surface of the filter, and the other surface. One side is a filter holder provided with a plurality of triangular plate-shaped ribs having three sides that form a flow path connected to the thin tube section.
4 . 請求項 2又は 3に記載のフィルターホルダー【こフィルターを内装し、 かつ、 その注入側の端部に検体収容容器を装着してある検査用フィルター ュニッ ト。  4. The filter holder according to claim 2 or 3, wherein the filter holder is provided inside and a sample container is mounted at an end on the injection side.
5 . フィルターホルダーと検体収容容器が着脱自在である請求項 4に記載 の検査用フィルターュニッ ト。  5. The test filter unit according to claim 4, wherein the filter holder and the sample container are detachable.
6 . 検体収容容器が転がり防止のための鍔部を有する請求項 4又は 5に記 載の検査用フィルターュニッ ト。  6. The test filter unit according to claim 4 or 5, wherein the sample container has a collar for preventing rolling.
7 . 検体収容容器がプラスチック材からなり、 手指による変形で加圧が可 能である請求項 4から 6のいずれかに記載の検査用 フィルターュニッ ト。  7. The test filter unit according to any one of claims 4 to 6, wherein the sample container is made of a plastic material, and can be pressurized by deformation with a finger.
8 . 少なく とも、 血液、 尿、 便、 鼻汁液、 痰、 或レヽはスヮブ検体と して収 集された分泌液から選ばれる 1つの検体液又はその希釈した液を濾過する ために用いる請求項 4から 7のいずれかに記載の検査用フィルターュニッ 卜。 8. At least one sample fluid selected from blood, urine, stool, nasal fluid, sputum, or secretory fluid collected as a sub-sample or a diluted fluid thereof is used for filtration. The inspection filter unit according to any one of 4 to 7.
9 . インフルエンザウイルス感染の有無の診断に用いる請求項 4から 8の いずれかに記載の検査用フィルターュニッ ト。  9. The test filter unit according to any one of claims 4 to 8, which is used for diagnosis of influenza virus infection.
1 0 . ィンフルェンザウィルス感染の有無の診断用器具と して診断キッ ト に組み込まれている請求項 4から 9のいずれかに記載の検査用フィルター ユニッ ト。 10. Diagnostic kit as a diagnostic tool for the presence or absence of infection with influenza virus An inspection filter unit according to any one of claims 4 to 9, wherein the inspection filter unit is incorporated in a filter.
PCT/JP2004/014565 2003-09-30 2004-09-28 Filter holder and inspection filter unit having the same WO2005031342A1 (en)

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MX359080B (en) * 2008-03-05 2018-09-06 Becton Dickinson Co Co-molded pierceable stopper and method for making the same.
JP5080395B2 (en) * 2008-08-01 2012-11-21 積水メディカル株式会社 Sample container
WO2016031899A1 (en) * 2014-08-28 2016-03-03 アルフレッサファーマ株式会社 Nozzle cap for specimen test container, and specimen test container and specimen test kit using same
JP6377662B2 (en) * 2016-03-22 2018-08-22 株式会社シン・コーポレイション Manufacturing method of filter unit
KR101743936B1 (en) 2016-04-21 2017-06-12 (주)알엠바이오 A container assembly for picking free medical treatment included pipet
WO2018225884A1 (en) * 2017-06-08 2018-12-13 (주)알엠바이오 Sample collection container assembly comprising pipette
JPWO2022138897A1 (en) * 2020-12-25 2022-06-30

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