WO1990007716A1 - Immunological inspection tube - Google Patents

Immunological inspection tube Download PDF

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Publication number
WO1990007716A1
WO1990007716A1 PCT/JP1988/001297 JP8801297W WO9007716A1 WO 1990007716 A1 WO1990007716 A1 WO 1990007716A1 JP 8801297 W JP8801297 W JP 8801297W WO 9007716 A1 WO9007716 A1 WO 9007716A1
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Prior art keywords
test tube
immunological
tube according
immunological test
substance
Prior art date
Application number
PCT/JP1988/001297
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French (fr)
Japanese (ja)
Inventor
Yasuo Murao
Shuntaro Hosaka
Original Assignee
Toray Industries, Inc.
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Publication date
Application filed by Toray Industries, Inc. filed Critical Toray Industries, Inc.
Priority to PCT/JP1988/001297 priority Critical patent/WO1990007716A1/en
Publication of WO1990007716A1 publication Critical patent/WO1990007716A1/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302—Apparatus specially adapted for immunological test procedures
    • G01N33/5304—Reaction vessels, e.g. agglutination plates

Definitions

  • the present invention relates to a test tube for performing an immunological agglutination reaction for the purpose of detecting an immunologically active substance such as an antigen or an antibody.
  • the substance that binds to the substance to be detected is immobilized on carrier particles of an appropriate size, and the particles are Utilizing the phenomenon of aggregation in the presence of the target substance, a method of detecting the target substance with high sensitivity is an important means of immunological clinical tests.
  • the visual determination of whether or not immunologically active substance-immobilized particles cause an immunological agglutination reaction is mainly performed by the following method.
  • One is a method in which a sample solution and a reagent for agglutination reaction are mixed and shaken on a plate, and after a few minutes, judgment is made based on whether or not an aggregate is observed.
  • Another method is to mix the sample solution and the reagent for agglutination in a microtiter plate and observe the sedimentation image of the reagent for agglutination after a few hours. is there.
  • each of the conventional methods has some problems.
  • the method of observing the presence or absence of agglomerates on a plate can be determined in a short time, but since drying is fast, the next test is performed after the determination is completed, so it is inefficient to test a large number of samples.
  • the aggregate itself is observed with the naked eye, the sensitivity is low.
  • the method of observing the sedimentation image of the agglutination reagent in a microtiter plate is highly sensitive but requires several hours to make a determination.
  • both methods require a process of collecting the sample liquid and adding a separately prepared agglutination reagent.
  • the inventors of the present invention used a freeze-dried and charged agglutination reagent and a sample liquid in a transparent tube described in JP-A-58-73666. After mixing in a tube, the mixture was allowed to stand horizontally, and after several tens of minutes, a method of observing the sedimentation image of the agglutination reagent and making a determination was invented. However, if the transparent tube used in this method has a uniform diameter, the freeze-dried agglutination reagent falls off the tube with a slight impact, and when the sample solution is inhaled, the agglutination reagent is used. Partially leaks out of the pipe. An object of the present invention is to solve such a problem and to provide the most advantageous immunological reaction test tube.
  • the present invention is an immunological test tube comprising a transparent tube having at least one end fitted with a passage, and further containing a freeze-dried immunological agglutination reagent in the tube.
  • FIG. 1 shows a preferred embodiment of the present invention, wherein 1 is a pitta, and 2 is an agglutination reagent.
  • FIG. 2 shows the inspection results of the example, in which (a) shows the (1) image and (b) shows the (+) image.
  • the material of the test tube of the present invention may be plastic or glass such as polystyrene, polyethylene, polypropylene, polycarbonate, polyvinyl chloride, and polymethyl methacrylate.
  • plastic or glass such as polystyrene, polyethylene, polypropylene, polycarbonate, polyvinyl chloride, and polymethyl methacrylate.
  • polystyrene and glass are particularly preferable.
  • the diameter of the test tube is preferably 1 to 5 dragons in inner diameter, particularly preferably about 2 inner diameters.
  • the length of the tube is preferably 1 to 10 cm, more preferably 3 to 5 cm.
  • Means for narrowing the passage include narrowing the tube or packing or bonding a porous substance such as absorbent cotton or a filter, but the thinner tube is preferable.
  • the inner diameter of the tip should be 0.3 to 1. It is preferable that the thickness be reduced to five, particularly about 1 mm.
  • the agglutination reagent may be charged in advance by freeze-drying or may be charged by freeze-drying in a tube, but it is preferable to charge the reagent in the vicinity of the tight tip in the tube.
  • the agglutination reagent here refers to a substance that specifically binds to a substance to be measured or a substance to be measured immobilized on a carrier.
  • the substance to be immobilized on these carriers is not particularly limited, and specifically, hepatitis (types A and B) virus, AIDS virus (HIV-IE), ATL virus (HIV-I), and herpes (herpes) Simplex, Brown zela soster) virus, cytome garovirus, measles virus, rubella virus, polio-mauizores, no.
  • Viruses such as Lactobacillus botulinum, Botulinum, Pulcella, Shigella, Vibrio parahaemolyticus, Pest, Escherichia coli, Campylobacter, Gangsita, Toxoplasma, Malaria parasite, and Trebonemapari dam.
  • antigens derived from microorganisms such as bacteria, fungi, and protozoa, C-reactive protein, carcinoembryonic antigen, --futoprotein, human chorionic gonadotropin, heat-aggregated immunoglobulin G, hemoglobin, nucleoprotein, nucleic acid , Estrogen, complement components, strepturidin 0, etc., or substances such as antibodies against them.
  • These substances include blood cells (fixed with formalin, etc.), bacterial cells, polystyrene latex, (meta) acrylonitrile-based polymers, and (meta) acrylic acid esters. It is immobilized on a carrier such as a polymer as a main component or other polymer micro beads by adsorption, ionic bond or covalent bond.
  • the test tube of the present invention has a cap-shaped or cylindrical pipe made of elastic rubber, plastic, or the like, at the end where no reagent is charged in order to aspirate the sample liquid into the tube. Or, preferably, have a piston. In addition, an existing micropitter or the like may be connected and used. Alternatively, the sample solution may be injected using another pipet.
  • FIG. 1 A preferred example of the present invention is shown in FIG. 1
  • the test tube After inhaling or injecting the sample liquid, the test tube is placed horizontally, but if it is rolled in the meantime, it will disturb the sedimentation image of the agglutination reagent, which is not desirable.
  • a predetermined amount of a sample solution is inhaled or injected into the tube, and the prepared agglutination reagent and the sample solution are mixed well and left horizontally for several tens of minutes. After that, the presence or absence of agglutination is examined by observing the sedimentation image of the agglutination reagent.
  • the BSA-immobilized polymer microbead dispersion (0.63%) 20 ⁇ described in No. 1,562,113 was searched for and freeze-dried. After inhaling 20 d of a phosphate buffered saline (PBS) solution of 200 g Ab / ml of anti-BS ⁇ serum (rabbit) in the accompanying pipe, the tube is moved up and down or in the tube axis direction. By rotating the mixture, the BSA-immobilized polymer microbeads were mixed well and allowed to stand on a horizontal surface.
  • PBS phosphate buffered saline
  • anti-BSA antiserum (rabbit) was used by diluting the same ratio with BSA PBS solution (BSA 1 mg / ml). After 30 minutes, the results are shown in FIG. Fig. 2 shows the results when viewed from above the test tube.
  • the negative control to which BSA was added shows the (a) image of (a), and the negative control without BSA shows the (b) image. (+) Image was shown.
  • Example 2 In the same manner as in Example 2, a dispersion of polymer microbeads on which an anti-human hemoglobin antibody was immobilized was freeze-dried.
  • the human hemoglobin 0.1 ⁇ g Zml PBS solution 20 was inhaled, the same operation as in Example 1 was performed, and the mixture was allowed to stand on a horizontal surface. PBS was used as a negative control. Judging after 30 minutes, the human hemoglobin ⁇ .1 g Zml PBS solution showed the (+) image in FIG. 2 and the PBS solution showed the (-) image in FIG.
  • the present invention it is possible to stably hold an agglutination reagent prepared by freeze-drying,
  • the sample solution can be inhaled or injected without the reagent flowing out of the tube, and the agglutination reagent can be mixed at the same time as the sample solution is collected, which simplifies the operation. In addition, quick judgment is possible with tens of minutes.
  • the present invention is useful as a test tube for performing an immunological agglutination reaction for the purpose of detecting an immunoreactive substance such as an antigen or an antibody.

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  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
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  • General Health & Medical Sciences (AREA)
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Abstract

An agglutination can be judged through a simple procedure without any trouble such as the outflow of an agglutination reagent by use of an immunological inspection tube for agglutination consisting of a transparent tube having a path at least one of the ends of which is narrowed.

Description

明 細 書  Specification
免疫学的検査管  Immunological test tubes
技 術 分 野  Technical field
本発明は抗原あるいは抗体などの免疫活性物質を検出 する目的で、 免疫学的凝集反応を行なうための検査管に 関する。  The present invention relates to a test tube for performing an immunological agglutination reaction for the purpose of detecting an immunologically active substance such as an antigen or an antibody.
背 景 技 術  Background technology
抗原と抗体の反応を利用して、 そのいずれか一方を免 疫学的に検出する場合に、 検出したい物質に結合する物 質を適当な大きさの担体粒子に固定化しておき、 その粒 子が被検出物質の存在下に凝集を起こす現象を利用して、 被検出物質を高感度に検出する方法は免疫学的臨床検査 の重要な手段である。  In the case of immunologically detecting one of them by utilizing the reaction between an antigen and an antibody, the substance that binds to the substance to be detected is immobilized on carrier particles of an appropriate size, and the particles are Utilizing the phenomenon of aggregation in the presence of the target substance, a method of detecting the target substance with high sensitivity is an important means of immunological clinical tests.
従来、 免疫活性物質固定化粒子が免疫学的凝集反応を 起こすか否かの肉眼的判定は、 主に次に示すような方法 で行なわれている。 一つは平板上で検体液と凝集反応用 試薬を混合して浸盪し、 数分後に凝集塊が観察されるか 否かで判定する方法である。 他の方法はマイクロタイ夕 一プレー トのゥュルの中で検体液と凝集反応用試薬を混 合し、 静置して数時間後に凝集反応用試薬の沈降像を観 察することにより判定する方法である。  Conventionally, the visual determination of whether or not immunologically active substance-immobilized particles cause an immunological agglutination reaction is mainly performed by the following method. One is a method in which a sample solution and a reagent for agglutination reaction are mixed and shaken on a plate, and after a few minutes, judgment is made based on whether or not an aggregate is observed. Another method is to mix the sample solution and the reagent for agglutination in a microtiter plate and observe the sedimentation image of the reagent for agglutination after a few hours. is there.
従来の方法にはそれぞれにいく つかの問題点がある。 まず平板上で凝集塊の存否を観察する方法は短時間で判 定できるが、 乾燥が速いため判定が終了した後に次の検 定を行なうので、 多数の検体を検査するには効率が悪い。 しかも凝集塊そのものを肉眼で観察するので感度も悪い。 マイクロタイタープレー トウヱル中での凝集反応試薬の 沈降像を観察する方法は、 高感度であるが判定に数時間 を要する。 さらに、 両方法共に検体液を採取し、 別途用 意した凝集反応試薬を添加する行程を経なければならな い。 Each of the conventional methods has some problems. First, the method of observing the presence or absence of agglomerates on a plate can be determined in a short time, but since drying is fast, the next test is performed after the determination is completed, so it is inefficient to test a large number of samples. Moreover, since the aggregate itself is observed with the naked eye, the sensitivity is low. The method of observing the sedimentation image of the agglutination reagent in a microtiter plate is highly sensitive but requires several hours to make a determination. In addition, both methods require a process of collecting the sample liquid and adding a separately prepared agglutination reagent.
以上の如き問題点を克服すべく、 本発明者らは特開昭 5 8 - 7 3 8 6 6号記載の透明な管の中に凍結乾燥して 仕込まれた凝集反応試薬と検体液をその管内で混合した 後、 水平に静置して数十分後に凝集反応試薬の沈降像を 観察して判定する方法を発明した。 しかし、 この方法に 用いる透明な管が均一径である場合は、 凍結乾燥して仕 込まれた凝集反応試薬がわずかな衝撃で管外に脱落し、 また検体液を吸入する際に凝集反応試薬が一部管外に流 出する。 本発明はかかる問題点を解決し、 最も有利な免 疫学的反応用検査管を提供することを目的とする。  In order to overcome the problems described above, the inventors of the present invention used a freeze-dried and charged agglutination reagent and a sample liquid in a transparent tube described in JP-A-58-73666. After mixing in a tube, the mixture was allowed to stand horizontally, and after several tens of minutes, a method of observing the sedimentation image of the agglutination reagent and making a determination was invented. However, if the transparent tube used in this method has a uniform diameter, the freeze-dried agglutination reagent falls off the tube with a slight impact, and when the sample solution is inhaled, the agglutination reagent is used. Partially leaks out of the pipe. An object of the present invention is to solve such a problem and to provide the most advantageous immunological reaction test tube.
発 明 の 開 示  Disclosure of the invention
本発明は、 通路の少なく とも一端がせばめられた透明 な管から成り、 さらに管内に凍結乾燥した免疫学的凝集 反応試薬を仕込んで成る免疫学的検査管である。  The present invention is an immunological test tube comprising a transparent tube having at least one end fitted with a passage, and further containing a freeze-dried immunological agglutination reagent in the tube.
図面の簡単な説明  BRIEF DESCRIPTION OF THE FIGURES
第 1図は本発明の好ましい一実施態様を示すものであ り、 1はピぺッタ、 2は凝集反応試薬を示す。  FIG. 1 shows a preferred embodiment of the present invention, wherein 1 is a pitta, and 2 is an agglutination reagent.
また、 aはピペッ トの断面図、 bは本発明の検査管の 横断面図、 c はせばめられた先端部分の断面図である。 第 2図は実施例の検査結果を示すものであり、 （ a ) は （一） 像、 （b ) は （+ ) 像を示す。 Also, a is a cross-sectional view of the pipette, b is a cross-sectional view of the test tube of the present invention, and c is a cross-sectional view of the fitted tip. FIG. 2 shows the inspection results of the example, in which (a) shows the (1) image and (b) shows the (+) image.
発明を実施するための最良の形態 本発明の検査管の材質と しては、 ポリスチレン、 ポリ エチレン、 ポ リプロピレン、 ポリ カーボネー ト、 ポリ塩 化ビニル、 ポリメチルメ タク リ レー ト等のプラスチッ ク あるいはガラスが好ま しく 、 特にポリスチレン、 ガラス が好ま しい。  BEST MODE FOR CARRYING OUT THE INVENTION The material of the test tube of the present invention may be plastic or glass such as polystyrene, polyethylene, polypropylene, polycarbonate, polyvinyl chloride, and polymethyl methacrylate. However, polystyrene and glass are particularly preferable.
検査管の管径は、 内径 1 〜 5龍が好ま しく 、 特に好ま しく は内径約 2誦である。 また、 管の長さは 1 〜 1 0 cm が好ま しく 、 さらに 3〜 5 cmが好ま しい。  The diameter of the test tube is preferably 1 to 5 dragons in inner diameter, particularly preferably about 2 inner diameters. The length of the tube is preferably 1 to 10 cm, more preferably 3 to 5 cm.
仕込まれた凝集反応試薬の脱落、 あるいは検体液吸入 時に凝集反応試薬が流出するのを防止するために通路の 少なく とも一端をせばめることが必要である。 通路をせ ばめる手段と しては、 管を細く する、 あるいは脱脂綿、 フィ ルタ一等の多孔性物質をつめるか、 または接着する ことが挙げられるが、 管を細く することが好ま しい。  In order to prevent the charged agglutinating reagent from dropping out or the agglutinating reagent from flowing out when inhaling the sample liquid, it is necessary to short at least one end of the passage. Means for narrowing the passage include narrowing the tube or packing or bonding a porous substance such as absorbent cotton or a filter, but the thinner tube is preferable.
管を細く する場合、 わずかに細く することで凝集反応 試薬の脱落を防止することができるが、 検体液吸入時の 凝集反応試薬の流出を防ぐには、 先端の内径を 0 . 3〜 1 . 5翻まで細く することが好ま しく 、 約 1 mmが特に好 ま しい。  When making the tube thinner, it is possible to prevent the agglutination reagent from dropping by making it slightly smaller.However, to prevent the agglutination reagent from flowing out when inhaling the sample liquid, the inner diameter of the tip should be 0.3 to 1. It is preferable that the thickness be reduced to five, particularly about 1 mm.
また、 凝集反応試薬は予め凍結乾燥したものを仕込ん でも、 管内で凍結乾燥することにより仕込んでもよいが、 試薬を管内のせばめられた先端付近に仕込むことが好ま しい。 The agglutination reagent may be charged in advance by freeze-drying or may be charged by freeze-drying in a tube, but it is preferable to charge the reagent in the vicinity of the tight tip in the tube. New
こ こでいう凝集反応試薬とは、 測定したい物質に特異 的に結合する物質、 あるいは測定したい物質を担体に固 定化させたものである。 これら担体に固定化させる物質 は特に限定されないが、 具体的には肝炎 （A型、 B型） ウィルス、 A I D S ウィルス （H I V— IE ) 、 A T Lゥ ィルス （ H I V— I ) 、 ヘルぺス （ヘルぺスシンプレツ クス、 バリ ゼラゾースター） ウィルス、 サイ トメ ガロウ ィルス、 麻疹ウィルス、 風疹ウィルス、 ポリオ一マウイ ゾレス、 ノヽ。ピロ一マウィルス、 S V 4 0 ウィルス、 コクサ ツキ一ウィルス、 エコーウィルス、 イ ンフルエンザウイ ルス、 狂犬病ウィルス、 、 黄熱病ウィルス、 日本脳炎ゥ ィルス、 マールブルダ病ウィルス、 アデノウイルス、 デ ングウィルス、 E Bゥイノレス、 マンプスウィルス、 ワク シニアウィルス、 パルボウイルス、 ロタウィルス、 タナ ボッ クスウイゾレス、 ヤノ ウイブレス、 ラ ッサ熱ウィルス、 タバコモザイ クウィルス、 マイ コプラズマ、 ッッガムシ リケッチヤ、 Q熱リケッチヤ、 発疹チフス リ ケッチヤ、 クラ ミ ディ ア トラコ一マティ ス、 クラ ミ ディ アプシタコ シス、 リ ン菌、 破傷風菌、 黄色ブドウ球菌、 レンサ球菌、 結核菌、 緑膿菌、 炭疽菌、 肺炎球菌、 サルモネラ菌、 コ レラ菌、 チフス菌、 ノ、。ラチフス菌、 ボツ リ ヌス菌、 プル セラ菌、 赤痢菌、 腸炎ビブリオ菌、 ペス ト菌、 大腸菌、 カ ンピロバクタ一、 ガンジタ菌、 トキソプラズマ、 マラ リ ア原虫、 ト レボネ一マパリ ダムなどのウィルス、 ある いは細菌、 真菌、 原生動物などの微生物由来の抗原、 C 反応性蛋白、 癌胎児性抗原、 —フユ トプロテイ ン、 ヒ ト絨毛性ゴナ ドトロピン、 熱凝集ィムノグロブリ ン G、 ヘモグロ ビン、 核蛋白、 核酸、 エス ト ロゲン、 補体成分、 ス ト レブト リ ジン 0など、 あるいはそれらに対する抗体 などの物質である。 The agglutination reagent here refers to a substance that specifically binds to a substance to be measured or a substance to be measured immobilized on a carrier. The substance to be immobilized on these carriers is not particularly limited, and specifically, hepatitis (types A and B) virus, AIDS virus (HIV-IE), ATL virus (HIV-I), and herpes (herpes) Simplex, Bali zela soster) virus, cytome garovirus, measles virus, rubella virus, polio-mauizores, no. Piloma virus, SV40 virus, Kokusa Tsuki virus, Echo virus, Influenza virus, Rabies virus, Yellow fever virus, Japanese encephalitis virus, Marbruda disease virus, Adenovirus, Dengue virus, EB @ Inores, Mumps Virus, Vaccinia virus, Parvovirus, Rotavirus, Tana box wizores, Yano uibres, Lassa fever virus, Tobacco mosaic virus, Mycoplasma, Raccia rickettsia, Q fever rickettsia, Rash typhus rickettsia, Chlamy di atra comaty , Chlamydia apsittachosis, Lin bacteria, Tetanus, Staphylococcus aureus, Streptococcus, Mycobacterium tuberculosis, Pseudomonas aeruginosa, Anthrax, Pneumococcus, Salmonella, Cholera, Salmonella typhi, No. Viruses such as Lactobacillus botulinum, Botulinum, Pulcella, Shigella, Vibrio parahaemolyticus, Pest, Escherichia coli, Campylobacter, Gangsita, Toxoplasma, Malaria parasite, and Trebonemapari dam. Or antigens derived from microorganisms such as bacteria, fungi, and protozoa, C-reactive protein, carcinoembryonic antigen, --futoprotein, human chorionic gonadotropin, heat-aggregated immunoglobulin G, hemoglobin, nucleoprotein, nucleic acid , Estrogen, complement components, strepturidin 0, etc., or substances such as antibodies against them.
これらの物質は、 血球 （ホルマリ ン等により固定） 、 菌体、 ポリスチレンラテッ クス、 （メ タ） ァク リ ロニ ト リルを主成分とする重合体,、 （メ タ） アク リル酸エステ ルを主成分とする重合体、 その他ポ リマーマイクロ ビー ズ等の担体に吸着、 イオン結合または共有結合により固 定化される。  These substances include blood cells (fixed with formalin, etc.), bacterial cells, polystyrene latex, (meta) acrylonitrile-based polymers, and (meta) acrylic acid esters. It is immobilized on a carrier such as a polymer as a main component or other polymer micro beads by adsorption, ionic bond or covalent bond.
本発明の検査管は、 管中へ検体液を吸入するために、 試薬が仕込まれていない方の端に、 弾力性を有するゴム、 プラスチック等のキャ ップ状または筒状のピぺッタ、 あ るいはピス ト ンを備えていることが好ま しい。 その他に 既存のマイクロピぺッタ等を接続して用いてもよい。 あ るいは、 検体液を別のピぺッ トを用いて注入しても構わ ない。  The test tube of the present invention has a cap-shaped or cylindrical pipe made of elastic rubber, plastic, or the like, at the end where no reagent is charged in order to aspirate the sample liquid into the tube. Or, preferably, have a piston. In addition, an existing micropitter or the like may be connected and used. Alternatively, the sample solution may be injected using another pipet.
本発明の好ま しい例を第 1図に示す。  A preferred example of the present invention is shown in FIG.
検体液を吸入または注入後、 検査管は水平に静置され るが、 その間にころがると、 凝集反応試薬の沈降像を乱 すことになり好ま しく ないので、 検体番号等の標示を兼 ねた紙、 プラスチッ ク等の羽根状のものを、 検体液の吸 入、 あるいは沈降像の観察に支障のない部分に取り付け、 ころがりを防止することが好ましい。 さらに、 一定量の 検体液を吸入あるいは注入するために、 管に目盛を付与 する ことは一層好ま しい。 After inhaling or injecting the sample liquid, the test tube is placed horizontally, but if it is rolled in the meantime, it will disturb the sedimentation image of the agglutination reagent, which is not desirable. Attach a wing-shaped object, such as paper or plastic, to a section that does not interfere with sample liquid inhalation or sedimentation image observation. It is preferable to prevent rolling. Further, it is even more preferable to provide a scale on the tube for inhaling or injecting a certain amount of the sample liquid.
本発明による検査管を用い免疫活性物質を検出するに は、 検体液を管中に一定量吸入または注入し、 仕込まれ た凝集反応試薬と検体液を充分混合して水平に数十分静 置した後、 凝集反応試薬の沈降像を観察することにより、 凝集の有無を検定する。  In order to detect an immunologically active substance using the test tube according to the present invention, a predetermined amount of a sample solution is inhaled or injected into the tube, and the prepared agglutination reagent and the sample solution are mixed well and left horizontally for several tens of minutes. After that, the presence or absence of agglutination is examined by observing the sedimentation image of the agglutination reagent.
以下に実施例を示し、 本発明を詳細に説明する。  Hereinafter, the present invention will be described in detail with reference to Examples.
実 施 例 1 Example 1
第 1図に示すせばめられていない部分の内径 2讓、 せ ばめられた先端の内径 1難、 長さ 4 emよりなるガラス製 の管のせばめられた先端部分内に、 特開昭 56— 1 56 2 1 3号公報に記載の B S A固定化ポリマーマイクロビ ーズ分散液 （0. 63%) 20 ^ を探り、 凍結乾燥し た。 付随のピぺッ夕で 200 g A b /mlの抗 B S Α抗 血清 （兎） のリ ン酸緩衝生理食塩水 （ P B S ) 溶液 20 dを吸入した後、 管を管軸方向に上下あるいは管を回 転することにより、 B S A固定化ポリマーマイクロビ一 ズをよく混合して、 水平面上に静置した。 なお、 陰性対 照は抗 B S A抗血清 （兎） を B S Aの P B S溶液 （B S A 1 mg/ml) で同率に希釈して使用した。 30分後、 判 定した結果を第 2図に示す。 第 2図は検査管の上方から 見た結果であり、 B S Aを添加した陰性対照は （a ) の (一） 像を示し、 B S Aを添加しなかった方は （b) の (+ ) 像を示した。 In the fitted end of a glass tube having the inner diameter of the unfitted portion shown in FIG. 1 and the inner diameter of the fitted tip of 1 mm and a length of 4 em, as shown in FIG. The BSA-immobilized polymer microbead dispersion (0.63%) 20 ^ described in No. 1,562,113 was searched for and freeze-dried. After inhaling 20 d of a phosphate buffered saline (PBS) solution of 200 g Ab / ml of anti-BS Α serum (rabbit) in the accompanying pipe, the tube is moved up and down or in the tube axis direction. By rotating the mixture, the BSA-immobilized polymer microbeads were mixed well and allowed to stand on a horizontal surface. For negative control, anti-BSA antiserum (rabbit) was used by diluting the same ratio with BSA PBS solution (BSA 1 mg / ml). After 30 minutes, the results are shown in FIG. Fig. 2 shows the results when viewed from above the test tube. The negative control to which BSA was added shows the (a) image of (a), and the negative control without BSA shows the (b) image. (+) Image was shown.
実 施 例 2  Example 2
特開昭 56 - 14 1 5 59号公報に記載のポリマーマ イク口 ビーズに抗 α—フヱ トプロティ ン抗体を固定化し、 この分散液 （0. 63%) 20 ^ を実施例 1 と同様に 凍結乾燥した。 付随のピぺッ夕で 20 ngZinlの 一フエ トプロテイ ンを含む 20倍希釈ヒ ト血清 2◦ を吸入 した後、 実施例 1 と同じ操作を行ない水平面上に静置し た。 なお陰性対照は、 上記希釈液に杭 一フエ トプロテ ィ ン抗体を 1 g / mlとなるように加えたものと した。 3◦分後に判定すると、 抗 α—フヱ トプロテイ ンを加え た陰性対照は第 2図の （一） 像を示し、 抗 —フユ トプ 口ティ ンを加えなかった方は （+ ) 像を示した。  An anti-α-photoprotein antibody was immobilized on the beads of polymer micro mouth described in JP-A-56-14559, and this dispersion (0.63%) 20 ^ was frozen in the same manner as in Example 1. Dried. After inhaling 2 ◦ 20-fold diluted human serum containing 20 ng Zinl of monoprotein in the accompanying pipette, the same operation as in Example 1 was performed, and the mixture was allowed to stand on a horizontal surface. The negative control was prepared by adding the stake protein protein to the above diluent at a concentration of 1 g / ml. Judgment after 3 ° minutes, the negative control to which anti-α-photoprotein was added shows the image (1) in FIG. 2 and the one to which no anti-futopin tin was added shows the (+) image. Was.
実 施 例 3 Example 3
実施例 2と同様にして、 抗ヒ トーヘモグロ ビン抗体を 固定化したポリマーマイ クロビーズの分散液を凍結乾燥 した。 付随のピぺッ夕でヒ ト 一ヘモグロ ビン 0. 1 ^ g Zml P B S溶液 20 を吸入し、 実施例 1 と同じ操作 を行ない水平面上に静置した。 陰性対照は P B Sを使用 した。 30分後に判定すると、 ヒ トーヘモグロ ビン◦ . 1 g Zml P B S溶液の方は第 2図の （+ ) 像を示し、 P B Sの方は （―） 像を示した。  In the same manner as in Example 2, a dispersion of polymer microbeads on which an anti-human hemoglobin antibody was immobilized was freeze-dried. In the accompanying pipette, the human hemoglobin 0.1 ^ g Zml PBS solution 20 was inhaled, the same operation as in Example 1 was performed, and the mixture was allowed to stand on a horizontal surface. PBS was used as a negative control. Judging after 30 minutes, the human hemoglobin ◦ .1 g Zml PBS solution showed the (+) image in FIG. 2 and the PBS solution showed the (-) image in FIG.
産業上の利用可能性  Industrial applicability
以上のように、 本発明は凍結乾燥して仕込まれた凝集 反応試薬を安定に保持することが可能であり、 凝集反応 試薬が管外に流出することなく検体液を吸入または注入 することができる上に、 凝集反応試薬は検体液採取と同 時に混合が可能なので操作が簡便となる。 しかも数十分 で迅速な判定が可能である。 As described above, according to the present invention, it is possible to stably hold an agglutination reagent prepared by freeze-drying, The sample solution can be inhaled or injected without the reagent flowing out of the tube, and the agglutination reagent can be mixed at the same time as the sample solution is collected, which simplifies the operation. In addition, quick judgment is possible with tens of minutes.
従って、 本発明は抗原あるいは抗体などの免疫活性物 質を検出する目的で、 免疫学的凝集反応を行なうための 検査管として有用である。  Therefore, the present invention is useful as a test tube for performing an immunological agglutination reaction for the purpose of detecting an immunoreactive substance such as an antigen or an antibody.

Claims

請 求 の 範 囲 The scope of the claims
(1) 通路の少なく とも一端がせばめられた透明な管か ら成り、 さらに管内に凍結乾燥した免疫学的凝集反応試 薬を仕込んで成る免疫学的検査管。  (1) An immunological test tube consisting of a transparent tube with at least one end fitted with a passage, and further containing a freeze-dried immunological agglutination reagent in the tube.
(2) 通路の両端がせばめられた請求の範囲第 1項記載 の免疫学的検査管。  (2) The immunological test tube according to claim 1, wherein both ends of the passage are fitted.
(3) 検査管の材質がポ リ スチレン、 ポ リエチレン、 ポ リプロ ピレン、 ポリカーボネー ト、 ポリ塩化ビニル、 ポ リ メ チルメ タク リ レー トおよびガラスから成る群から選 ばれるものである請求の範囲第 1項記載の免疫学的検査 管。  (3) The test tube is made of a material selected from the group consisting of polystyrene, polyethylene, polypropylene, polycarbonate, polyvinyl chloride, polymethylmethacrylate, and glass. The immunological test tube according to item 1.
(4) 検査管の材質がポ リ スチレンである請求の範囲第 3項記載の免疫学的検査管。  (4) The immunological test tube according to claim 3, wherein the material of the test tube is polystyrene.
(5) 検査管の材質がガラスである請求の範囲第 3項記 載の.免疫学的検査管。  (5) The immunological test tube according to claim 3, wherein the material of the test tube is glass.
(6) 検査管の長さが 1〜 1 0 cmである請求の範囲第 1 項記載の免疫学的検査管。  (6) The immunological test tube according to claim 1, wherein the test tube has a length of 1 to 10 cm.
(7) 検査管の長さが 3〜 5 cmである請求の範囲第 6項 記載の免疫学的検査管。  (7) The immunological test tube according to claim 6, wherein the length of the test tube is 3 to 5 cm.
(8) 検査管のせばめられていない部分の内径が 1 〜 5 關である請求の範囲第 1項記載の免疫学的検査管。  (8) The immunological test tube according to claim 1, wherein the inner diameter of the unfitted portion of the test tube is 1 to 5 members.
(9) 通路の端をせばめる手段が、 管を細くする手段、 多孔性物質をつめる手段または多孔性物質を接着する手 段である請求の範囲第 1項記載の免疫学的検査管。  (9) The immunological test tube according to claim 1, wherein the means for narrowing the end of the passage is a means for narrowing a tube, a means for packing a porous substance, or a means for bonding a porous substance.
(10) 通路の端をせばめる手段が、 管を細くする手段で ある請求の範囲第 9項記載の免疫学的検査管。 (10) The means of narrowing the end of the passage is the means of narrowing the pipe 10. The immunological test tube according to claim 9.
(11) 細く した管の先端の内径が 0 . 3〜 1 . 5麵で ある請求の範囲第 1 0項記載の免疫学的検査管。  (11) The immunological test tube according to claim 10, wherein the inner diameter of the tip of the thinned tube is 0.3 to 1.5 mm.
(12) 免疫学的凝集反応試薬が測定したい物質に特異 的に結合する物質、 あるいは測定したい物質を担体に固 定化させたものである請求の範囲第 1項記載の免疫学的 検査管。  (12) The immunological test tube according to claim 1, wherein the immunological agglutination reagent specifically binds to a substance to be measured or a substance to be measured is immobilized on a carrier.
(13) 担体に固定化される物質が抗原あるいは抗体で ある請求の範囲第 1 2項記載の免疫学的検査管。  (13) The immunological test tube according to claim 12, wherein the substance immobilized on the carrier is an antigen or an antibody.
(14) 担体が血球、 菌体、 ポリマーマイクロビーズで ある請求の範囲第 1 2項記載の免疫学的検査管。  (14) The immunological test tube according to claim 12, wherein the carrier is blood cells, bacterial cells, or polymer microbeads.
(15) ポリマーマイクロビーズが （メ タ） ァク リ ロ二 ト リルを主成分とする重合体よりなる請求の範囲第 1 4 項記載の免疫学検査管。  (15) The immunological test tube according to claim 14, wherein the polymer microbeads are made of a polymer containing (meth) acrylonitrile as a main component.
(16) ポリマ一マイクロビーズが （メ タ） アク リル酸 エステルを主成分とする重合体より成る請求の範囲第 1 (16) The polymer microbeads are composed of a polymer containing (meth) acrylic acid ester as a main component.
4項記載の免疫学的検査管。 The immunological test tube according to item 4.
(17) 免疫学的凝集反応試薬が通路のせばめられた先 端付近に仕込まれた請求の範囲第 1項記載の免疫学的検  (17) The immunological test according to claim 1, wherein the immunological agglutination reagent is charged near the fitted end of the passage.
(18) 試薬の仕込まれていない方の端に、 ピぺッタぁ るいはビス トンを備えている請求の範囲第 1項記載の免 疫学的検査管。 (18) The immunological test tube according to claim 1, wherein a pitter or a bistone is provided at an end where no reagent is charged.
(19) 検査管がころがり防止用羽根を有している請求 の範囲第 1項記載の免疫学的検査管。 (19) The immunological test tube according to claim 1, wherein the test tube has anti-rolling blades.
( 20) ころがり防止用羽根が検体番号標示を兼ねた請 求の範囲第 1 9項記載の免疫学的検査管。 (20) The immunological test tube according to item (19), wherein the anti-rolling blade also serves as a sample number label.
(21) 検査管に目盛りが付与された請求の範囲第 1項 記載の免疫学的検査管。  (21) The immunological test tube according to claim 1, wherein a scale is provided on the test tube.
PCT/JP1988/001297 1988-12-23 1988-12-23 Immunological inspection tube WO1990007716A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS4117920Y1 (en) * 1964-03-09 1966-08-19
JPS5873866A (en) * 1981-10-28 1983-05-04 Toray Ind Inc Immunological method for detection
JPS61213770A (en) * 1985-03-20 1986-09-22 Toyobo Co Ltd Diagnostic reagent kit

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS4117920Y1 (en) * 1964-03-09 1966-08-19
JPS5873866A (en) * 1981-10-28 1983-05-04 Toray Ind Inc Immunological method for detection
JPS61213770A (en) * 1985-03-20 1986-09-22 Toyobo Co Ltd Diagnostic reagent kit

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