CA2838708C - Diagnostic devices, methods and systems for detecting platelet factor 4 (pf4)/heparin antibodies - Google Patents

Diagnostic devices, methods and systems for detecting platelet factor 4 (pf4)/heparin antibodies Download PDF

Info

Publication number
CA2838708C
CA2838708C CA2838708A CA2838708A CA2838708C CA 2838708 C CA2838708 C CA 2838708C CA 2838708 A CA2838708 A CA 2838708A CA 2838708 A CA2838708 A CA 2838708A CA 2838708 C CA2838708 C CA 2838708C
Authority
CA
Canada
Prior art keywords
antibody
conjugate
sample
zone
antibodies
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.)
Active
Application number
CA2838708A
Other languages
English (en)
French (fr)
Other versions
CA2838708A1 (en
Inventor
Suzette CHANCE
Gian Paolo Visentin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gen Probe Inc
Original Assignee
Gen Probe Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Gen Probe Inc filed Critical Gen Probe Inc
Publication of CA2838708A1 publication Critical patent/CA2838708A1/en
Application granted granted Critical
Publication of CA2838708C publication Critical patent/CA2838708C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • 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
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • 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
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • G01N33/54387Immunochromatographic test strips
    • G01N33/54388Immunochromatographic test strips based on lateral flow
    • 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
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/32Cardiovascular disorders

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Peptides Or Proteins (AREA)
CA2838708A 2011-06-09 2012-06-05 Diagnostic devices, methods and systems for detecting platelet factor 4 (pf4)/heparin antibodies Active CA2838708C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161495171P 2011-06-09 2011-06-09
US61/495,171 2011-06-09
PCT/US2012/040938 WO2012170435A2 (en) 2011-06-09 2012-06-05 Diagnostic devices, methods and systems for detecting platelet factor 4 (pf4)/heparin antibodies

Publications (2)

Publication Number Publication Date
CA2838708A1 CA2838708A1 (en) 2012-12-13
CA2838708C true CA2838708C (en) 2020-07-21

Family

ID=46317508

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2838708A Active CA2838708C (en) 2011-06-09 2012-06-05 Diagnostic devices, methods and systems for detecting platelet factor 4 (pf4)/heparin antibodies

Country Status (6)

Country Link
US (1) US9599623B2 (enExample)
EP (1) EP2718724B1 (enExample)
JP (1) JP6075799B2 (enExample)
AU (1) AU2012268393B2 (enExample)
CA (1) CA2838708C (enExample)
WO (1) WO2012170435A2 (enExample)

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI498166B (zh) * 2013-07-02 2015-09-01 Univ Nat Taiwan 以表面電漿共振定量分析之自動操作檢測程序的多孔性薄膜微流體裝置
EP3063544B1 (en) * 2013-10-29 2021-05-26 Versiti Blood Research Institute Foundation, Inc. Method of detecting platelet activating antibodies that cause heparin-induced thrombocytopenia/thrombosis
CN105980842B (zh) * 2013-12-06 2019-12-17 奥索临床诊断有限公司 具有清洗口的测定装置
GB2523135A (en) * 2014-02-13 2015-08-19 Molecular Vision Ltd Assay device
US20150044707A1 (en) * 2014-02-18 2015-02-12 Melinda Sanders At-Home Blood Pregnancy Test Kit
CN104076014A (zh) * 2014-06-30 2014-10-01 安徽师范大学 一种荧光传感器,其制备方法,用途以及检测Heparin分子的方法
GB2528657B (en) * 2014-07-24 2019-03-13 Intelligent Fingerprinting Ltd Sample analysing device
BR112017005121A2 (pt) * 2014-09-23 2018-07-31 Tearlab Res Inc sistemas e métodos para integração de coleta de lágrima microfluídica e análise de fluxo lateral de analitos de interesse.
RU2702645C2 (ru) * 2014-12-11 2019-10-09 Критикал Кэа Дайэгностикс, Инк. Тестовый аппарат и способы для сердечного биологического маркера st2
US10324089B2 (en) 2014-12-11 2019-06-18 Critical Care Diagnostics, Inc. Test apparatus and methods for ST2 cardiac biomarker
GB2535998A (en) 2015-02-27 2016-09-07 Intelligent Fingerprinting Ltd A device for receiving and analysing a sample
KR101635956B1 (ko) * 2015-03-16 2016-07-06 (주)큐브바이오 천공 부재를 구비하는 진단 키트
EP3392655B1 (en) * 2015-12-18 2020-08-19 FUJIFILM Corporation Immunochromatographic kit
CN108780076A (zh) 2016-01-27 2018-11-09 隐蔽色彩股份有限公司 用于检测液体中目标物质的可穿戴装置
US10073092B2 (en) * 2016-02-19 2018-09-11 Andrew Wang Apparatus for assay strip(s) with specimen loading to multiple zones and related methods
WO2017151642A1 (en) * 2016-02-29 2017-09-08 Flora Bioscience, Inc. Detection apparatus
WO2018128749A1 (en) * 2017-01-06 2018-07-12 Dnt Scientific Research, Llc Rapid diagnostic test device by driven flow technology
EP3413051B1 (de) * 2017-06-09 2020-07-29 Siemens Healthcare Diagnostics Products GmbH Aktivierungstest zur diagnose einer heparin-induzierten thrombozytopenie
US10458974B2 (en) * 2017-06-09 2019-10-29 Optimum Imaging Diagnostics LLC Universal testing system for quantitative analysis
EP3438667B1 (de) * 2017-08-02 2020-12-30 Siemens Healthcare Diagnostics Products GmbH Bindungstest zur diagnose einer heparin-induzierten thrombozytopenie
CN107727851A (zh) * 2017-11-15 2018-02-23 北京舜雷科技有限公司 一种免疫凝集和胶体金层析试纸条相结合的用于检测hit抗体的系统
WO2019202395A1 (en) * 2018-04-20 2019-10-24 Biokit Research & Developments, S.L.U. Heparin-induced thrombocytopenia assay
USD959015S1 (en) * 2020-06-05 2022-07-26 Zhejiang Orient Gene Biotech Co., LTD COVID immunoassay test device
USD954982S1 (en) * 2020-06-30 2022-06-14 Hangzhou Biotest Biotech Co., Ltd. COVID immunoassay test device
USD954983S1 (en) * 2020-09-04 2022-06-14 Hangzhou Biotest Biotech Co., Ltd. COVID immunoassay test device
CN112842334A (zh) * 2021-02-08 2021-05-28 德莫德(苏州)机械科技有限公司 一种翻转式加样及按压式加液的一体化胶体金卡盒
USD977673S1 (en) * 2021-03-26 2023-02-07 Zhejiang Orient Gene Biotech Co., LTD Test card
USD1069617S1 (en) * 2021-03-29 2025-04-08 Owen Mumford Limited Testing device
KR102281805B1 (ko) * 2021-04-22 2021-07-26 주식회사 제트바이오텍 형광염료를 이용한 건식 타입 형광 정량분석 체외 진단키트 및 그 제조방법
USD1025392S1 (en) * 2022-01-25 2024-04-30 Acon Biotech (Hangzhou) Co.Ltd. Test device
USD990704S1 (en) * 2022-07-14 2023-06-27 Andon Health Co., Ltd. Test strip for medical or laboratory purposes
USD1054585S1 (en) * 2023-01-14 2024-12-17 Zhejiang Orient Gene Biotech Co., LTD Test card
CA219722S (en) * 2023-01-16 2024-06-27 Zhejiang Orient Gene Biotech Co Ltd Test card
USD1053379S1 (en) * 2023-01-19 2024-12-03 Zhejiang Orient Gene Biotech Co., LTD United test card
USD1101961S1 (en) * 2023-04-28 2025-11-11 Charles River Laboratories International, Inc. Cartridge
CA221817S (en) * 2023-05-24 2024-09-25 Zhejiang Orient Gene Biotech Co Ltd Test card
CA221818S (en) * 2023-05-24 2024-10-22 Zhejiang Orient Gene Biotech Co Ltd Test card
USD1086484S1 (en) * 2023-06-26 2025-07-29 Hangzhou Biotest Biotech Co., Ltd Liquid sample test device
CN117471105B (zh) * 2023-12-27 2024-03-26 北京芯迈微生物技术有限公司 双向双驱序贯式血小板hla抗体检测的微流控芯片及应用

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4981786A (en) * 1987-09-04 1991-01-01 Syntex (U.S.A.) Inc. Multiple port assay device
US5466582A (en) 1990-08-09 1995-11-14 Serbio Thrombocytopenia determination
US5972717A (en) 1995-05-10 1999-10-26 The Blood Center Research Foundation, Inc. Method and kit for detecting heparin induced thrombocytopenia
US5972718A (en) * 1996-02-28 1999-10-26 The Blood Center Research Foundation Method of detecting heparin-induced thrombocytopenia
DE19927783A1 (de) * 1999-06-18 2000-12-21 Roche Diagnostics Gmbh Element zur Bestimmung eines Analyts in einer Flüssigkeit, entsprechendes Bestimmungsverfahren unter Verwendung des Elementes sowie Kit zur Bestimmugn eines Analyts
US6964854B1 (en) 1999-07-13 2005-11-15 Science & Technology Corporation Compositions and methods useful for the diagnosis and treatment of heparin induced thrombocytopenia/thrombosis
US6713309B1 (en) * 1999-07-30 2004-03-30 Large Scale Proteomics Corporation Microarrays and their manufacture
DE60031576D1 (en) 1999-08-30 2006-12-07 Wesagen Diagnostisches assay für typ-2-heparin induzierte thrombocytopenie
EP2144064A3 (en) 2004-10-04 2010-05-26 Akers Biosciences, Inc. Methods and kits for detecting heparin/platelet factor 4 antibodies
US7629127B2 (en) * 2005-01-21 2009-12-08 Dexall Biomedical Labs, Inc. Method for the visual detection of specific antibodies by the use of lateral flow assays
US7871781B2 (en) * 2005-05-23 2011-01-18 Phadia Ab Two step lateral flow assay methods and devices
FR2902884B1 (fr) 2006-06-23 2008-12-26 Hyphen Biomed Soc Par Actions Procede pour la detection des anticorps heparine-dependants et le diagnostic des pathologies immunes ou auto-immnues potentialisees par l'heparine telle que la thrombopenie induite par l'heparine
JP4198182B1 (ja) * 2007-12-28 2008-12-17 有限会社バイオデバイステクノロジー イムノクロマト分析法及びイムノクロマト分析キット
US8940495B2 (en) * 2008-02-29 2015-01-27 BioMedomics, Inc Rapid and sensitive method for quantitative determination of the level of heparin—PF4 complex induced immunoglobulin antibodies
JP5642361B2 (ja) * 2008-07-03 2014-12-17 ジョンソン・アンド・ジョンソン・アーベー 循環抗体の分析のための方法
WO2010024271A1 (ja) * 2008-08-27 2010-03-04 三菱化学メディエンス株式会社 修飾抗ヘパリン/pf4複合体抗体及びhit抗体標準品
US10114012B2 (en) * 2008-10-31 2018-10-30 The Board Of Trustees Of The Leland Stanford Junior University Methods and assays for detecting and quantifying pure subpopulations of white blood cells in immune system disorders

Also Published As

Publication number Publication date
JP6075799B2 (ja) 2017-02-08
US20150064800A1 (en) 2015-03-05
EP2718724A2 (en) 2014-04-16
WO2012170435A2 (en) 2012-12-13
US9599623B2 (en) 2017-03-21
JP2014517311A (ja) 2014-07-17
CA2838708A1 (en) 2012-12-13
AU2012268393B2 (en) 2016-09-15
WO2012170435A3 (en) 2013-06-13
EP2718724B1 (en) 2017-08-09
AU2012268393A1 (en) 2014-01-16

Similar Documents

Publication Publication Date Title
CA2838708C (en) Diagnostic devices, methods and systems for detecting platelet factor 4 (pf4)/heparin antibodies
US9250236B2 (en) Method to increase specificity and/or accuracy of lateral flow immunoassays
AU2013277910B2 (en) Quick test device and method
US20100129841A1 (en) Detection of a blood coagulation activity marker in a body fluid sample
US12422444B2 (en) Lateral flow immunoassays for the detection of antibodies against biological drugs
US10302654B2 (en) Anti-VLA-4 related assays
CN111868528A (zh) 侧向流动免疫测定条状装置
JPH08509806A (ja) 方法およびアッセイ
JP6751055B2 (ja) イムノクロマトグラフィーを利用した癌胎児性フィブロネクチンの検出方法
CN106556703A (zh) 一种慢性肾脏病标志物suPAR检测试剂盒和制备方法
JP2009258095A (ja) クロマトグラフィー分析用ストリップの製造方法
CN115097129A (zh) 一种用于胎盘生长因子和可溶性fms样酪氨酸激酶-1的检测试剂组合
JP6168580B1 (ja) イムノクロマトグラフィーを利用した癌胎児性フィブロネクチンの検出方法
WO2019026870A1 (ja) sFlt-1(可溶型血管内皮増殖因子受容体-1)の新規測定法
JP2004189665A (ja) 抗c反応性タンパク質抗体、この抗体を用いたバイオセンサ、この抗体の作製方法、及びこの抗体を用いた免疫測定方法
US12429488B2 (en) Monoclonal antibody against D-dimer and diagnosis agent for detecting D-dimer, crosslinked fibrin and its derivatives containing D-dimer by using the antibody
JP2019028053A (ja) sFlt−1(可溶型血管内皮増殖因子受容体−1)の新規測定法

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20170530