JPH07506429A - 血液凝固検定を行うためのテスト物品及び方法 - Google Patents
血液凝固検定を行うためのテスト物品及び方法Info
- Publication number
- JPH07506429A JPH07506429A JP5519301A JP51930193A JPH07506429A JP H07506429 A JPH07506429 A JP H07506429A JP 5519301 A JP5519301 A JP 5519301A JP 51930193 A JP51930193 A JP 51930193A JP H07506429 A JPH07506429 A JP H07506429A
- Authority
- JP
- Japan
- Prior art keywords
- membrane
- blood
- blood coagulation
- test article
- test
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/56—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
-
- 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
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/521—Single-layer analytical elements
- G01N33/523—Single-layer analytical elements the element being adapted for a specific analyte
-
- 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
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2337/00—N-linked chromogens for determinations of peptidases and proteinases
- C12Q2337/20—Coumarin derivatives
- C12Q2337/22—7-Amino-4-methylcoumarin, i.e. AMC, MCA
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- General Health & Medical Sciences (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- General Physics & Mathematics (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Food Science & Technology (AREA)
- Pathology (AREA)
- Cell Biology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- General Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.テスト物品であって: 血液凝固経路を実質的に妨害しない、側面の対位置においてアプリケーション外 面及びインジケーター外面をもつ透過性膜:その膜内に含浸された血液凝固開始 剤;及びその血液凝固経路の成分による活性化の間に検出可能なシグナルを作り 出す、その膜内に含浸された基質:を含んで成り、それにより、全血がその膜の アプリケーター外面に適用され、そして検出可能なシグナルがその血液凝固経路 成分の生成の結果としてそのインジケーター外面上に作り出されるような、テス ト物品。 2.透過性膜が、血液凝固経路を妨害しない親水性の非膨潤性材料から成る、請 求項1に記載のテスト物品。 3.材料が、ポリスルホンである、請求項2に記載のテスト物品。 4.ポリスルホンが、不斉構造である、請求項3に記載のテスト物5.透過性膜 が、血液凝固経路の妨害を阻害するように処理された親水性の非膨潤性材料であ る、請求項1に記載のテスト物品。 6.血液凝固開始剤が、外因性血液凝固経路を開始させる、請求項1に記載のテ スト物品。 7.血液凝固開始剤が、トロンボプラスチン、又は他の因子VII活性化物質か ら成る群から選ばれている、請求項6に記載のテスト物品。 8.血液凝固開始剤が、内因性血液凝固経路を開始させる、請求項1に記載のテ スト物品。 9.血液凝固開始剤が、エラグ酸、カオリン、シリカ、又は他の因子XII活性 化物質から成る群から選ばれている、請求項8に記載のテスト物品。 10.基質を活性化する血液凝固経路成分が、トロンビンである、請求項1に記 載のテスト物品。 11.トロンビン基質が、リポーター分子に共有結合したペプチドであり、ここ で、トロンビンがそのペプチドに結合し、そしてそのペプチドからリポーター分 子を解裂させ、検出可能なシグナルを作り出すような、請求項10に記載のテス ト物品。 12.検出可能なシグナルが、蛍光である、請求項11に記載のテスト物品。 13.血液凝固経路及び膜材料に適したpHを維持する膜内に含浸されたバッフ ァーをさらに含んで成る、請求項1に記載のテスト物品。 14.膜内に含浸されたカルシウムをさらに含んで成る、請求項1に記載のテス ト物品。 15.膜内に含浸された顔料をさらに含んで成る、請求項1に記載のテスト物品 。 16.膜内に含浸された流れ制御剤をさらに含んで成る、請求項1に記載のテス ト物品。 17.テスト物品であって: 透過性不斉ポリスルホン膜: その膜内に含浸されたトロンボプラスチン;及びその膜内に含浸されたトロンビ ン基質であって、蛍光リポーター分子に共有結合したトロンビン結合ペプチドを 含んで成り、それによりトロンビンがその基質から蛍光リポーターを放出するよ うなトロンビン基質; を含んで成り、 それにより、全血がその膜の1つの外面に適用されることができ、そして蛍光が そのトロンビン基質のトロンビン仲介解裂の結果としてその反対外面上で検出さ れるような、テスト物品。 18.血液凝固経路及び膜材料に適したpHを維持する膜内に含浸されたバッフ ァーをさらに含んで成る、請求項17に記載のテスト物品。 19.膜内に含浸されたカルシウムをさらに含んで成る、請求項117に記載の テスト物品。 20.膜内に含浸された顔料をさらに含んで成る、請求項17に記載のテスト物 品。 21.膜内に含浸された流れ制御剤をさらに含んで成る、請求項17に記載のテ スト物品。 22.患者の血液凝固能力の測定方法であって:全血サンプルを、透過性膜のア プリケーション外面に適用すること、ここで、その膜が血液凝固経路を実質的に 妨害せず、そして血液凝固開始剤、及びその血液凝固経路の成分による活性化の 間に検出可能なシグナルを作り出す基質が、その膜内に含浸されており;並びに その膜のインジケーター外面上で視覚的シグナルを検出すること、ここで、その インジケーター外面が上記アプリケーター外面に側面に対して置かれており、そ してその視覚的シグナルが、上記血液凝固開始剤及び血液の相互作用によりその 膜内で開始された血液凝固経路成分の生成から生じる、 を含んで成る方法。 23.全血サンプルが、適用に先立って測定されない、請求項22に記載の方法 。 24.全血サンプルが、指を刺すこと(finger prick)により得ら れる、請求項23に記載の方法。 25.室温において行われる、請求項22に記載の方法。 26.制御温度において行われる、請求項22に記載の方法。 27.検出可能なシグナルが蛍光である、請求項22に記載の方法。 28.検出可能なシグナルが温度補正される、請求項22に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US87466792A | 1992-04-27 | 1992-04-27 | |
US874,667 | 1992-04-27 | ||
PCT/US1993/003564 WO1993022453A1 (en) | 1992-04-27 | 1993-04-14 | Test article and method for performing blood coagulation assays |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH07506429A true JPH07506429A (ja) | 1995-07-13 |
JP3368279B2 JP3368279B2 (ja) | 2003-01-20 |
Family
ID=25364294
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP51930193A Expired - Lifetime JP3368279B2 (ja) | 1992-04-27 | 1993-04-14 | 血液凝固検定を行うためのテスト物品及び方法 |
Country Status (10)
Country | Link |
---|---|
US (1) | US5418143A (ja) |
EP (1) | EP0638127B1 (ja) |
JP (1) | JP3368279B2 (ja) |
AU (1) | AU4287593A (ja) |
CA (1) | CA2133983C (ja) |
DE (1) | DE69329280T2 (ja) |
DK (1) | DK0638127T3 (ja) |
ES (1) | ES2151509T3 (ja) |
GR (1) | GR3034647T3 (ja) |
WO (1) | WO1993022453A1 (ja) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000241384A (ja) * | 1999-02-23 | 2000-09-08 | Asulab Sa | 血液凝固時間を測定するための電気化学的システム |
JP2006126206A (ja) * | 1999-11-15 | 2006-05-18 | I-Stat Corp | 液体試料において凝血を分析する装置と方法 |
JP2006516743A (ja) * | 2003-02-05 | 2006-07-06 | ザ ジェネラル ホスピタル コーポレーション | Hiv診断関連用途のためのマイクロチップをベースとしたシステム |
JP2010085411A (ja) * | 2008-10-02 | 2010-04-15 | Siemens Healthcare Diagnostics Products Gmbh | 血液凝固アッセイ |
WO2014050926A1 (ja) * | 2012-09-28 | 2014-04-03 | 中外製薬株式会社 | 血液凝固反応の評価方法 |
JP2014514590A (ja) * | 2011-05-16 | 2014-06-19 | ザ・スウォッチ・グループ・リサーチ・アンド・ディベロップメント・リミテッド | トロンビンセンサの貯蔵寿命の増大 |
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US5344754A (en) * | 1993-01-13 | 1994-09-06 | Avocet Medical, Inc. | Assay timed by electrical resistance change and test strip |
US5418141A (en) * | 1994-05-06 | 1995-05-23 | Avocet Medical, Inc. | Test articles for performing dry reagent prothrombin time assays |
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US7148067B2 (en) * | 2004-08-31 | 2006-12-12 | The Board Of Trustees Of The University Of Illinois | Thromboplastin reagents |
EP1853926A2 (en) * | 2005-02-16 | 2007-11-14 | The Board Of Trustees Of The University Of Illinois | Procoagulants based on metal-chelating lipids |
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-
1993
- 1993-04-14 JP JP51930193A patent/JP3368279B2/ja not_active Expired - Lifetime
- 1993-04-14 DK DK93912264T patent/DK0638127T3/da active
- 1993-04-14 ES ES93912264T patent/ES2151509T3/es not_active Expired - Lifetime
- 1993-04-14 EP EP93912264A patent/EP0638127B1/en not_active Expired - Lifetime
- 1993-04-14 DE DE69329280T patent/DE69329280T2/de not_active Expired - Lifetime
- 1993-04-14 WO PCT/US1993/003564 patent/WO1993022453A1/en active IP Right Grant
- 1993-04-14 CA CA002133983A patent/CA2133983C/en not_active Expired - Lifetime
- 1993-04-14 AU AU42875/93A patent/AU4287593A/en not_active Abandoned
-
1994
- 1994-02-09 US US08/196,816 patent/US5418143A/en not_active Expired - Lifetime
-
2000
- 2000-10-20 GR GR20000402334T patent/GR3034647T3/el unknown
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000241384A (ja) * | 1999-02-23 | 2000-09-08 | Asulab Sa | 血液凝固時間を測定するための電気化学的システム |
JP4662596B2 (ja) * | 1999-02-23 | 2011-03-30 | アスラブ ソシエテ アノニム | 血液凝固時間を測定するための電気化学的システム |
JP2006126206A (ja) * | 1999-11-15 | 2006-05-18 | I-Stat Corp | 液体試料において凝血を分析する装置と方法 |
JP2006516743A (ja) * | 2003-02-05 | 2006-07-06 | ザ ジェネラル ホスピタル コーポレーション | Hiv診断関連用途のためのマイクロチップをベースとしたシステム |
JP2010085411A (ja) * | 2008-10-02 | 2010-04-15 | Siemens Healthcare Diagnostics Products Gmbh | 血液凝固アッセイ |
JP2014514590A (ja) * | 2011-05-16 | 2014-06-19 | ザ・スウォッチ・グループ・リサーチ・アンド・ディベロップメント・リミテッド | トロンビンセンサの貯蔵寿命の増大 |
WO2014050926A1 (ja) * | 2012-09-28 | 2014-04-03 | 中外製薬株式会社 | 血液凝固反応の評価方法 |
JPWO2014050926A1 (ja) * | 2012-09-28 | 2016-08-22 | 中外製薬株式会社 | 血液凝固反応の評価方法 |
US11078518B2 (en) | 2012-09-28 | 2021-08-03 | Chugai Seiyaku Kabushiki Kaisha | Method for evaluating blood coagulation reaction |
Also Published As
Publication number | Publication date |
---|---|
JP3368279B2 (ja) | 2003-01-20 |
EP0638127A1 (en) | 1995-02-15 |
GR3034647T3 (en) | 2001-01-31 |
EP0638127B1 (en) | 2000-08-23 |
WO1993022453A1 (en) | 1993-11-11 |
CA2133983A1 (en) | 1993-11-11 |
DE69329280T2 (de) | 2001-03-15 |
AU4287593A (en) | 1993-11-29 |
ES2151509T3 (es) | 2001-01-01 |
EP0638127A4 (en) | 1997-03-19 |
DK0638127T3 (da) | 2000-12-18 |
US5418143A (en) | 1995-05-23 |
DE69329280D1 (de) | 2000-09-28 |
CA2133983C (en) | 2004-04-06 |
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