JP5404795B2 - 液体試験ストリップ及び方法 - Google Patents
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- 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
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- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- 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
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
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- 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
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
- G01N33/54388—Immunochromatographic test strips based on lateral flow
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- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
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- 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
- G01N33/536—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase
- G01N33/537—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
- G01N33/539—Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody involving precipitating reagent, e.g. ammonium sulfate
- G01N33/541—Double or second antibody, i.e. precipitating antibody
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/08—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a stream of discrete samples flowing along a tube system, e.g. flow injection analysis
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/06—Fluid handling related problems
- B01L2200/0647—Handling flowable solids, e.g. microscopic beads, cells, particles
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/16—Reagents, handling or storing thereof
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/069—Absorbents; Gels to retain a fluid
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
- B01L2300/087—Multiple sequential chambers
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/817—Enzyme or microbe electrode
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/97—Test strip or test slide
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/975—Kit
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S436/00—Chemistry: analytical and immunological testing
- Y10S436/807—Apparatus included in process claim, e.g. physical support structures
- Y10S436/808—Automated or kit
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S436/00—Chemistry: analytical and immunological testing
- Y10S436/823—Immunogenic carrier or carrier per se
Description
本発明とその好適な使用態様、他の目的、及び利点とは、添付の図面と実施形態の下記の詳細な説明を参照することで最も良く理解されるであろう。
ステップ21:検体1101を含む体液サンプルを準備する(図1Bに示すように)。
ステップ22:連続して配置された第1領域111、第2領域112、及び第3領域113を有する1つ以上のチャネル11を有する基板10を準備する。第1領域111は体液サンプルを導入するための領域であり、第1抗体1111を有する。第2領域112は中に第2抗体1121が固定されている。第1抗体1111と第2抗体1121とは体液サンプル中の検体1101の異なるエピトープを認識するよう構成されている。従って、第1抗体1111と第2抗体1121が同じ抗原を求めて互いに競合して抗原の認識を妨げない限り、第1抗体1111と第2抗体1121の両方が単クローン抗体(mAbs)か多クローン抗体(pAbs)のいずれかであってよい。光学基質1131と糖類オキシダーゼ1133からなる基質試薬1132とが第3領域113に入れられている。ペルオキシダーゼ1113はHRP(セイヨウワサビペルオキシダーゼ)、AP(アスコルビン酸ペルオキシダーゼ)、又は水素ペルオキシダーゼであってよい。光学基質1131は好ましくは5‐アミノ‐2,3‐ジヒドロ‐1,4‐フタラジンジオンであり、糖類1112は好ましくはグルコースであり、糖類オキシダーゼ1133はグルコースオキシダーゼである。また、糖類1112とペルオキシダーゼ1113は、第1実施形態で説明したのと同様にチャネル11に亘って配置される(図1B、図1F、図1G、及び図1Hを参照)。
10 基板
11 チャネル
111 第1領域
112 第2領域
113 第3領域
1101 検体
1111 第1抗体
1112 糖類
1113 ペルオキシダーゼ
1121 第2抗体
1131 光学基質
1132 基質試薬
1133 糖類オキシダーゼ
Claims (2)
- 連続して配置された、体液サンプルを導入するために使用される第1領域と、第2領域と、第3領域とを有する1つ以上のチャネルを有する基板を備える体液中の検体の定量分析のための試験ストリップであって、
該体液サンプル中の検体を認識するために該第1領域に入れられた第1抗体と、
該第1領域又は該第2領域に入れられた糖類と、
該第1領域又は該第2領域に入れられたペルオキシダーゼと、
該体液サンプル中の検体を認識するために該第2領域内に固定された第2抗体と、
該第3領域に入れられた光学基質及び糖類オキシダーゼと
を備え、
該第1抗体と該第2抗体とは該体液サンプル中の該検体の異なるエピトープを認識するよう構成され、
該検体を含む該体液サンプルを該チャネルに導入すると直ちに、該検体は該第1抗体と結合し、該第1抗体、該糖類、及び該ペルオキシダーゼは該体液サンプルと一緒に流れ、該検体は該第2抗体と結合し、該第1抗体及び該第2抗体と結合した該検体、該検体と結合した該第1抗体、及び該検体と結合した該第1抗体と共役する該ペルオキシダーゼとが該第2領域内に保持され、該糖類、該検体と結合していない該第1抗体、及び該検体と結合していない該第1抗体と共役する該ペルオキシダーゼとが該体液サンプルと一緒に該第3領域へ流れ、該糖類は該第3領域に到達し該糖類オキシダーゼの触媒作用で過酸化水素を生成し、次に該光学基質は該第3領域に到達した該ペルオキシダーゼの触媒作用により該過酸化水素と反応して光学信号を生成する、液体試験ストリップ。 - 検体を含む体液サンプルを準備するステップと;
連続して配置された、体液サンプルを導入するために使用される第1領域と、第2領域と、第3領域とを有する1つ以上のチャネルを有する基板を準備するステップと、
ここで、該基板は、
該体液サンプル中の該検体を認識するために該第1領域に入れられた第1抗体と、
該第1領域又は該第2領域に入れられた糖類と、
該第1領域又は該第2領域に入れられたペルオキシダーゼと、
該体液サンプル中の該検体を認識するために該第2領域内に固定された第2抗体と、
該第3領域に入れられた光学基質及び糖類オキシダーゼと
を更に備え、
該第1抗体と該第2抗体とは該検体の異なるエピトープを認識するよう構成され、
該体液サンプルを該チャネルの該第1領域に導入して、該第1抗体、該糖類、及び該ペルオキシダーゼが該体液サンプルと一緒に流れるのを可能にするステップと;
該検体、該検体と結合した該第1抗体、該第2抗体、該検体と結合した該第1抗体と共役する該ペルオキシダーゼとが該第2領域内に保持されるのを可能にするステップと、
該糖類、該検体と結合していない第1抗体、該検体と結合していない該第1抗体と共役する該ペルオキシダーゼ、及び該検体とが、該体液サンプルと一緒に該第3領域へ流れ、該第3領域に到達した該糖類が該糖類オキシダーゼの触媒作用で過酸化水素を生成するのを可能にするステップと、
該第3領域に到達した該ペルオキシダーゼの触媒作用により該光学基質が該過酸化水素と反応して光学信号を生成するのを可能にするステップと;
該生成された光学信号を検出するステップと
を含む体液中の検体の定量分析のための検出方法。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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PCT/CN2008/001750 WO2010043075A1 (zh) | 2008-10-17 | 2008-10-17 | 流体检测试片及其测试方法 |
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JP2012505418A JP2012505418A (ja) | 2012-03-01 |
JP5404795B2 true JP5404795B2 (ja) | 2014-02-05 |
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JP2011531321A Expired - Fee Related JP5404795B2 (ja) | 2008-10-17 | 2008-10-17 | 液体試験ストリップ及び方法 |
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US (1) | US7964370B2 (ja) |
EP (1) | EP2352026B1 (ja) |
JP (1) | JP5404795B2 (ja) |
KR (1) | KR101178009B1 (ja) |
CN (1) | CN102171566B (ja) |
AU (1) | AU2008362976B2 (ja) |
ES (1) | ES2429114T3 (ja) |
IL (1) | IL211964A0 (ja) |
WO (1) | WO2010043075A1 (ja) |
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2008
- 2008-10-17 EP EP08877352.8A patent/EP2352026B1/en not_active Not-in-force
- 2008-10-17 JP JP2011531321A patent/JP5404795B2/ja not_active Expired - Fee Related
- 2008-10-17 KR KR1020117008110A patent/KR101178009B1/ko not_active IP Right Cessation
- 2008-10-17 CN CN2008801313561A patent/CN102171566B/zh not_active Expired - Fee Related
- 2008-10-17 US US12/442,446 patent/US7964370B2/en not_active Expired - Fee Related
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CN102171566A (zh) | 2011-08-31 |
CN102171566B (zh) | 2013-10-23 |
AU2008362976A1 (en) | 2010-04-22 |
US20100255512A1 (en) | 2010-10-07 |
EP2352026A4 (en) | 2012-04-11 |
ES2429114T3 (es) | 2013-11-13 |
KR20110073504A (ko) | 2011-06-29 |
JP2012505418A (ja) | 2012-03-01 |
AU2008362976B2 (en) | 2013-03-28 |
WO2010043075A1 (zh) | 2010-04-22 |
KR101178009B1 (ko) | 2012-08-28 |
US7964370B2 (en) | 2011-06-21 |
EP2352026B1 (en) | 2013-08-14 |
EP2352026A1 (en) | 2011-08-03 |
IL211964A0 (en) | 2011-06-30 |
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