ES2652495T3 - Método para detectar anticoagulantes lúpicos - Google Patents

Método para detectar anticoagulantes lúpicos Download PDF

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Publication number
ES2652495T3
ES2652495T3 ES12800902.4T ES12800902T ES2652495T3 ES 2652495 T3 ES2652495 T3 ES 2652495T3 ES 12800902 T ES12800902 T ES 12800902T ES 2652495 T3 ES2652495 T3 ES 2652495T3
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blood
sample
time
coagulation
blood sample
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English (en)
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Masahiro IEKO
Chizuru Morikawa
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SCHOOL JURIDICAL PERSON HIGASHI-NIPPON-GAKUEN
Sekisui Medical Co Ltd
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SCHOOL JURIDICAL PERSON HIGASHI-NIPPON-GAKUEN
Sekisui Medical Co Ltd
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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
    • G01N33/86—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
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/10—Musculoskeletal or connective tissue disorders
    • G01N2800/101—Diffuse connective tissue disease, e.g. Sjögren, Wegener's granulomatosis
    • G01N2800/104—Lupus erythematosus [SLE]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/24—Immunology or allergic disorders

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  • 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)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Organic Chemistry (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medicinal Chemistry (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Rehabilitation Therapy (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (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)

Abstract

Un método para detectar anticoagulantes lúpicos, comprendiendo el método las siguientes etapas (A), (B) y (C): (A) añadir una composición solución tampón que contiene factores de coagulación sanguínea a cada una de una muestra de sangre y una muestra diluida de la muestra de sangre antes de la medición o en el momento de la medición del tiempo de coagulación sanguínea; (B) medir los tiempos de coagulación sanguínea para las diversas muestras de la etapa (A); y (C) comparar los tiempos de coagulación sanguínea para las diversas muestras obtenidas en la etapa (B), donde cuando la relación (tiempo de coagulación de la muestra diluida) / (tiempo de coagulación de la muestra de sangre) es menor de un valor de corte calculado a partir de valores medidos de plasmas de personas sanas sin anormalidad de coagulación, la muestra de sangre se considera que es positiva para anticoagulante lúpico.

Description

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Como se enumera en la Tabla 4, en los plasmas de pacientes deficientes en factor de coagulación (FVIII y FIX) en los que se niega la presencia de AL, los valores resultado fueron mayores de o iguales al valor de corte en el ensayo de cribado de TTPA, de manera que es difícil la discriminación de la positividad de AL. Por otro lado, en el ensayo de TVVRd, el ensayo de mezcla, y los Inventos 1 y 2, los valores resultado eran todos negativos. El método de la presente invención implica un sistema en el que los factores de coagulación se complementan a un plasma de ensayo; sin embargo, puesto que el método incluye un proceso de comparación de los valores obtenidos antes y después de la dilución, los resultados obtenidos en un estado en el que simplemente los factores de coagulación son deficientes, y los resultados en el caso que es positivo a inhibidor no son ambiguos. La discriminación se puede hacer claramente como en el caso del ensayo de TVVRd o el ensayo de mezcla.
imagen8
Como se enumera en la Tabla 5, en el grupo de administrado con heparina/no AL, los valores resultado en siete ejemplos de ocho ejemplos son todos mayores de o iguales al valor de corte en el ensayo de cribado de TTPA, de manera que es difícil la discriminación a partir de la positividad de AL. Además, en el ensayo de TVVRd, dos ejemplos de ocho ejemplos mostraron falsa positividad (en la tabla, indicado como “positivo*”). Por otro lado, los resultados eran todos negativos en las Invenciones 1 y 2.
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Claims (1)

  1. imagen1
ES12800902.4T 2011-06-17 2012-06-15 Método para detectar anticoagulantes lúpicos Active ES2652495T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2011135173 2011-06-17
JP2011135173 2011-06-17
PCT/JP2012/065433 WO2012173259A1 (ja) 2011-06-17 2012-06-15 ループスアンチコアグラントの検出方法

Publications (1)

Publication Number Publication Date
ES2652495T3 true ES2652495T3 (es) 2018-02-02

Family

ID=47357237

Family Applications (1)

Application Number Title Priority Date Filing Date
ES12800902.4T Active ES2652495T3 (es) 2011-06-17 2012-06-15 Método para detectar anticoagulantes lúpicos

Country Status (7)

Country Link
US (1) US9977038B2 (es)
EP (1) EP2722674B1 (es)
JP (1) JP6028314B2 (es)
KR (1) KR101979865B1 (es)
CA (1) CA2839117C (es)
ES (1) ES2652495T3 (es)
WO (1) WO2012173259A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE540132C2 (sv) 2014-05-22 2018-04-10 Zafena Ab Analysmetod för bestämning av antikoagulanter i blod eller blodplasma
JP6499488B2 (ja) * 2015-03-31 2019-04-10 学校法人東日本学園 凝固時間の測定方法、ループスアンチコアグラントの存否の判定方法及びループスアンチコアグラント検出用試薬キット
JP6837851B2 (ja) * 2017-01-31 2021-03-03 シスメックス株式会社 血液検体の判定方法、並びに血液検体の分析のための装置及びコンピュータプログラム
JP6873833B2 (ja) * 2017-06-09 2021-05-19 シスメックス株式会社 血液検体の判定方法、血液検体分析装置及びコンピュータプログラム

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5543145A (en) * 1984-09-17 1996-08-06 Baxter International, Inc. Pharmaceutical composition and method for the suppression of factor VIII inhibitor production
JPH0650999B2 (ja) 1988-09-12 1994-07-06 日本商事株式会社 血液凝固因子安定化法
US4877741A (en) 1988-10-24 1989-10-31 The United States Of America As Represented By The Secretary Of The Air Force Treatment of human plasma with brown recluse spider toxin to emulate a lupus anticoagulant
EP1562047B1 (en) 2004-02-06 2008-05-14 Sysmex Corporation Reagent kit for detecting lupus anticoagulant
US7932021B2 (en) 2005-07-28 2011-04-26 American Diagnostica, Inc. Lupus anticoagulant testing
CN101221189B (zh) 2007-01-12 2012-08-15 上海太阳生物技术有限公司 一种用于测定活化部分凝血活酶时间aptt的体外诊断试剂盒
CN102066947B (zh) 2008-06-18 2015-10-14 积水医疗株式会社 凝血时间延长原因的判定方法

Also Published As

Publication number Publication date
WO2012173259A1 (ja) 2012-12-20
EP2722674A4 (en) 2015-02-25
CN103649758A (zh) 2014-03-19
CA2839117A1 (en) 2012-12-20
US20140127725A1 (en) 2014-05-08
JPWO2012173259A1 (ja) 2015-02-23
JP6028314B2 (ja) 2016-11-16
CA2839117C (en) 2019-09-17
KR20140034230A (ko) 2014-03-19
EP2722674A1 (en) 2014-04-23
KR101979865B1 (ko) 2019-05-17
US9977038B2 (en) 2018-05-22
EP2722674B1 (en) 2017-11-29

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