DK2684056T3 - Method for monitoring anticoagulant therapy - Google Patents

Method for monitoring anticoagulant therapy Download PDF

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Publication number
DK2684056T3
DK2684056T3 DK12748059.8T DK12748059T DK2684056T3 DK 2684056 T3 DK2684056 T3 DK 2684056T3 DK 12748059 T DK12748059 T DK 12748059T DK 2684056 T3 DK2684056 T3 DK 2684056T3
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DK
Denmark
Prior art keywords
plasma
factor
coagulation
test
fiix
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DK12748059.8T
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English (en)
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Pall Torfi Onundarson
Brynja R Gudmundsdottir
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Flix Diagnostics
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Publication of DK2684056T3 publication Critical patent/DK2684056T3/da

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/56Measuring 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
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86Chemical 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Claims (14)

1. Fremgangsmåde til måling af aktiviteten af et vitamin K-antagonist-antikoagulationslægemiddel i en patient, og som er baseret på måling af kombineret aktivitet af både og kun koagulationsfaktorerne II og X i en testplasmaprøve fra patienten, hvilken fremgangsmåde omfatter: - blanding af testplasmaprøven med plasma, som kun mangler faktor II og faktor X, hvori forholdet mellem testplasmaprøven og mangelplasmaet er i intervallet fra 1:1 til 1:20, - tilsætning til testplasmaprøven af et eller flere koagulationsreagenser og calcium, og - bestemmelse af blodstørkningsevnen ved måling af blodstørkningstid eller thrombindannelse.
2. Fremgangsmåde ifølge krav 1, hvori det ene eller flere koagulationsreagenser er valgt fra gruppen bestående af: i) thromboplastin, ii) phospholipider, i i i) faktor IXa, iv) faktor Xla, v) faktor Xlla, vi) kallikrein, vii) exogen aktivator, inklusive slangegifte, som aktiverer faktor X, og viii) faktor Vila.
3. Fremgangsmåde ifølge krav 2, omfattende tilsætning af en kontaktaktivator valgt fra gruppen bestående af i) kaolinpartikler, ii) celit, iii) glaspartikler, iv) silicapartikler og v) ellaginsyre.
4. Fremgangsmåde ifølge ethvert af de foregående krav, som yderligere omfatter trinnet fortynding af testplasmaprøven med puffer eller saltopløsning.
5. Fremgangsmåde ifølge ethvert af de foregående krav, hvori koagulationsreagenset er fortyndet med vand, en vandig saltopløsning eller en pufret, vandig opløsning.
6. Fremgangsmåde ifølge ethvert af kravene 1 til 5, hvori mindst en komponent af koagulationsreagenset, mangelplasma eller calciumkilde er frysetørret, og hvori fremgangsmåden yderligere omfatter et trin til rekonstituering af denne mindst ene komponent.
7. Fremgangsmåde ifølge ethvert af kravene 1 til 6, hvori trinnet til bestemmelse af blodstørkningsevne omfater en fremgangsmåde valgt fra gruppen bestående af: - manuel/visuel koagulationsdetektion, - mekaniske og/eller elektroniske metoder til at observere viskositetsændringer, - optiske metoder til detektion af clotdannelse, - kromogen detektion under anvendelse af kromogene substrater, - fluorogen detektion under anvendelse af fluorogene substrater, og - luminogen detektion.
8. Testkit til måling af aktiviteten af et vitamin K-antagonist-antikoagulationslægemiddel i en patient, omfattende: - et koagulationsreagens, og - normal plasma, som kun mangler faktor II og faktor X, og som indeholder andre faktorer, inklusive faktor VII og IX (Fiix-deficient plasma), og - eventuelt omfattende en calciumionkilde.
9. Testkit ifølge krav 8 omfattende i en beholder koagulationsreagenset og det Fiix-deficiente plasma.
10. Testkit ifølge krav 8 eller 9 omfattende en første beholder omfattende koagulationsreagenset og det Fiix-deficiente plasma.
11. Testkit ifølge krav 8 omfattende i en første beholder koagulationsreagenset og i en anden beholder det Fiix-deficiente plasma.
12. Testkit ifølge ethvert af kravene 8 til 11, hvori koagulationsreagenset er valgt fra en eller flere af i) thromboplastin, ii) phospholipider, iii) faktor IXa, iv) faktor Xla, v) faktor Xlla, vi) kallikrein, vii) exogen aktivator, inklusive slangegifte, som aktiverer faktor X, og viii) faktor Vila.
13. Testkit ifølge krav 12, hvori koagulationsreagenset omfatter phospholipider, hvori kittet omfatter i en beholder koagulationsreagenset, en kontaktaktivator som beskrevet i krav 4, og Fiix-deficient plasma.
14. Testkit ifølge ethvert af kravene 8 til 13, hvori koagulationsreagenset og/eller det Fiix-deficiente plasma er frysetørret.
DK12748059.8T 2011-03-08 2012-03-08 Method for monitoring anticoagulant therapy DK2684056T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IS050010A IS2809B (is) 2011-03-08 2011-03-08 Blóðstorkumæling
PCT/IS2012/050005 WO2012120546A2 (en) 2011-03-08 2012-03-08 Method for monitoring anticoagulant therapy

Publications (1)

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DK2684056T3 true DK2684056T3 (da) 2017-07-10

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US (2) US9234902B2 (da)
EP (1) EP2684056B1 (da)
CN (1) CN103534595B (da)
DK (1) DK2684056T3 (da)
ES (1) ES2636318T3 (da)
IN (1) IN2013MN01890A (da)
IS (1) IS2809B (da)
RU (1) RU2607658C2 (da)
WO (1) WO2012120546A2 (da)

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US11181534B2 (en) 2014-04-04 2021-11-23 Bloodworks Routine laboratory and point-of-care (POC) testing for hemostasis
CN106574922B (zh) * 2014-05-05 2020-06-05 美国血液技术公司 用于检测纤维蛋白溶解和纤溶亢进的方法学和试剂
SE540132C2 (sv) * 2014-05-22 2018-04-10 Zafena Ab Analysmetod för bestämning av antikoagulanter i blod eller blodplasma
CN106461327B (zh) 2014-06-09 2019-12-13 泰尔茂比司特公司 冻干法
JP6871673B2 (ja) * 2015-03-31 2021-05-12 学校法人東日本学園 血液検体を判定するための方法、装置及びコンピュータプログラム、並びに血液検体分析装置
US11480559B2 (en) * 2016-01-07 2022-10-25 Fujimori Kogyo Co., Ltd. Blood collection tube, reagent, and method for analyzing blood characteristics using same
RU2655302C1 (ru) * 2017-05-15 2018-05-24 Федеральное государственное бюджетное образовательное учреждение высшего образования "Самарский государственный медицинский университет" Министерства здравоохранения Российской Федерации Способ прогнозирования эффективности антикоагулянтной терапии у больных с фибрилляцией предсердий, перенесших инсульт
RU2660706C1 (ru) * 2017-09-26 2018-07-09 федеральное государственное бюджетное учреждение "Национальный медицинский исследовательский центр профилактической медицины" Министерства здравоохранения Российской Федерации (ФГБУ "НМИЦ ПМ" Минздрава России) Скрининг-тест определения контактного пути коагуляции (СТОКПК)
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US11609043B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
CN110361531B (zh) * 2019-08-02 2023-04-11 天津医科大学总医院 一种检测微粒促凝活性的实验方法
CN114778858A (zh) * 2022-06-23 2022-07-22 深圳市帝迈生物技术有限公司 一种狼疮抗凝物检测试剂盒

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Also Published As

Publication number Publication date
ES2636318T3 (es) 2017-10-05
EP2684056A2 (en) 2014-01-15
WO2012120546A2 (en) 2012-09-13
WO2012120546A3 (en) 2012-11-29
CN103534595B (zh) 2016-03-09
US20120231485A1 (en) 2012-09-13
RU2013144950A (ru) 2015-04-20
RU2607658C2 (ru) 2017-01-10
IN2013MN01890A (da) 2015-09-25
IS2809B (is) 2012-10-15
US20160108457A1 (en) 2016-04-21
EP2684056B1 (en) 2017-05-03
US9234902B2 (en) 2016-01-12
CN103534595A (zh) 2014-01-22

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