JP6328655B2 - 反応時間を使用してアッセイを較正すること - Google Patents

反応時間を使用してアッセイを較正すること Download PDF

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JP6328655B2
JP6328655B2 JP2015542829A JP2015542829A JP6328655B2 JP 6328655 B2 JP6328655 B2 JP 6328655B2 JP 2015542829 A JP2015542829 A JP 2015542829A JP 2015542829 A JP2015542829 A JP 2015542829A JP 6328655 B2 JP6328655 B2 JP 6328655B2
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sample
reagent
compartment
signal
time
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JP2016500154A (ja
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ディン・チョン
スカリス・エドワード・アール
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オーソ・クリニカル・ダイアグノスティックス・インコーポレーテッド
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    • 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
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/557Immunoassay; Biospecific binding assay; Materials therefor using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502746Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means for controlling flow resistance, e.g. flow controllers, baffles
    • 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
    • G01N33/5302Apparatus specially adapted for immunological test procedures
    • 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
    • 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
    • G01N33/54306Solid-phase reaction mechanisms
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0825Test strips
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

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  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
JP2015542829A 2012-11-15 2013-11-15 反応時間を使用してアッセイを較正すること Active JP6328655B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261726626P 2012-11-15 2012-11-15
US61/726,626 2012-11-15
PCT/US2013/070341 WO2014078679A1 (en) 2012-11-15 2013-11-15 Calibrating assays using reaction time

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JP2016500154A JP2016500154A (ja) 2016-01-07
JP6328655B2 true JP6328655B2 (ja) 2018-05-23

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US (2) US9885712B2 (US07794700-20100914-C00194.png)
EP (1) EP2920591A4 (US07794700-20100914-C00194.png)
JP (1) JP6328655B2 (US07794700-20100914-C00194.png)
CN (2) CN110412265B (US07794700-20100914-C00194.png)
BR (1) BR112015011040A2 (US07794700-20100914-C00194.png)
CA (1) CA2891509C (US07794700-20100914-C00194.png)
IN (1) IN2015DN04062A (US07794700-20100914-C00194.png)
RU (1) RU2015121732A (US07794700-20100914-C00194.png)
WO (1) WO2014078679A1 (US07794700-20100914-C00194.png)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3129014A1 (en) 2012-11-15 2014-05-15 Ortho-Clinical Diagnostics, Inc. Quality/process control of a lateral flow assay device based on flow monitoring
US11002732B2 (en) * 2015-05-19 2021-05-11 Ortho-Clinical Diagnostics, Inc. Method of improving liquid sample flow in assay device
US10656151B2 (en) 2016-01-29 2020-05-19 Ortho-Clinical Diagnostics, Inc. Air capillary vent for a lateral flow assay device
JP2020507772A (ja) * 2017-02-10 2020-03-12 クイデル コーポレーション 制御流体フロー用チャネルを有する基材を用いたラテラルフローアッセイ
EP4160210A1 (en) * 2017-06-28 2023-04-05 Becton, Dickinson and Company Sandwich-type assays using decreasing signal portions of dose response curve to measure analytes, including analytes at high concentration
KR20190076624A (ko) * 2017-12-22 2019-07-02 삼성전자주식회사 검사 장치 및 그 제어방법
CA3088124A1 (en) * 2018-01-27 2019-08-01 Becton, Dickinsion And Company Multiplex lateral flow assay for differentiating bacterial infections from viral infections
CA3088126A1 (en) * 2018-01-27 2019-08-01 Becton, Dickinson And Company Multiplex lateral flow assay for differentiating bacterial infections from viral infections
JP7062285B2 (ja) * 2018-07-23 2022-05-16 国立研究開発法人産業技術総合研究所 アッセイプログラム及びアッセイ装置
CN110865197A (zh) * 2018-08-27 2020-03-06 襄阳中诚检测科技有限公司 一种分析分析物的离散样品等分试样的方法
JP7509800B2 (ja) * 2019-05-17 2024-07-02 クレオプティクス・アーゲー 被検体とリガンドとの間の反応の速度論的パラメータを決定するための方法

Family Cites Families (57)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4539295A (en) * 1983-06-30 1985-09-03 Beckman Instruments, Inc. Binary kinetic assay method and apparatus
ATE195022T1 (de) 1987-04-27 2000-08-15 Unilever Nv Spezifische bindungstestverfahren
US5120643A (en) 1987-07-13 1992-06-09 Abbott Laboratories Process for immunochromatography with colloidal particles
AU2684488A (en) 1988-06-27 1990-01-04 Carter-Wallace, Inc. Test device and method for colored particle immunoassay
US5252496A (en) 1989-12-18 1993-10-12 Princeton Biomeditech Corporation Carbon black immunochemical label
GB2243211A (en) 1990-04-20 1991-10-23 Philips Electronic Associated Analytical instrument and method of calibrating an analytical instrument
US5569608A (en) 1995-01-30 1996-10-29 Bayer Corporation Quantitative detection of analytes on immunochromatographic strips
US6258548B1 (en) 1997-06-05 2001-07-10 A-Fem Medical Corporation Single or multiple analyte semi-quantitative/quantitative rapid diagnostic lateral flow test system for large molecules
AU8148898A (en) 1997-06-23 1999-01-04 Luminex Corporation Interlaced lasers for multiple fluorescence measurement
US6436721B1 (en) 1997-07-25 2002-08-20 Bayer Corporation Device and method for obtaining clinically significant analyte ratios
HU222809B1 (hu) 1997-10-03 2003-10-28 77 Elektronika Műszeripari Kft. Eljárás és készülék kémiai összetevőnek anyagmintából, különösen vér glükóztartalmának vérmintából történő meghatározásához
US6830731B1 (en) 1998-01-05 2004-12-14 Biosite, Inc. Immunoassay fluorometer
SE521415C2 (sv) 1998-02-17 2003-10-28 Hans Goeran Evald Martin Metod för att framställa en gassensortillhörig detektor, samt en detektor framställd enligt metoden
EP1358987A3 (en) 1998-10-14 2004-03-03 Gyros AB A replication matrix
SE9903011D0 (sv) 1999-08-26 1999-08-26 Aamic Ab Sätt att framställa en plastprodukt och ett härför utnyttjat plastproduktformande arrangemang
WO2001020055A1 (en) 1999-09-10 2001-03-22 Åmic AB A method for the manufacturing of a matrix and a matrix manufactured according to the method
JP4562854B2 (ja) 2000-05-08 2010-10-13 パナソニック株式会社 クロマトグラフィー測定方法
US6519542B1 (en) 2000-05-09 2003-02-11 Agere Systems Inc Method of testing an unknown sample with an analytical tool
WO2001088534A2 (en) 2000-05-16 2001-11-22 Cygnus, Inc. Methods for improving performance and reliability of biosensors
JP2003004743A (ja) 2001-06-22 2003-01-08 Matsushita Electric Ind Co Ltd クロマトグラフィー定量測定装置
CN1287140C (zh) 2000-09-25 2006-11-29 松下电器产业株式会社 色层分析定量测量装置
US6541266B2 (en) 2001-02-28 2003-04-01 Home Diagnostics, Inc. Method for determining concentration of an analyte in a test strip
US20030119203A1 (en) * 2001-12-24 2003-06-26 Kimberly-Clark Worldwide, Inc. Lateral flow assay devices and methods for conducting assays
EP1493029B1 (en) 2002-04-10 2010-03-31 Response Biomedical Corporation Sensitive immunochromatographic assay
US7175992B2 (en) 2002-04-10 2007-02-13 Response Biomedical Corporation Sensitive immunochromatographic assay
SE0201738D0 (sv) 2002-06-07 2002-06-07 Aamic Ab Micro-fluid structures
DE10248555B4 (de) * 2002-10-18 2004-12-02 Roche Diagnostics Gmbh Verfahren und Analysesystem zur Ermittlung der Konzentration eines Analyten in einer Probe, die aus dem Analyten und der Probenmatrix besteht und Testelement dafür
US7118916B2 (en) 2002-10-21 2006-10-10 Lifescan, Inc. Method of reducing analysis time of endpoint-type reaction profiles
SE0400662D0 (sv) 2004-03-24 2004-03-24 Aamic Ab Assay device and method
SE527036C2 (sv) 2004-06-02 2005-12-13 Aamic Ab Analysanordning med reglerat flöde och motsvarande förfarande
US7439079B2 (en) * 2005-04-29 2008-10-21 Kimberly-Clark Worldwide, Inc. Assay devices having detection capabilities within the hook effect region
US7635594B2 (en) 2005-05-09 2009-12-22 Theranos, Inc. Point-of-care fluidic systems and uses thereof
SE529254C2 (sv) 2005-06-17 2007-06-12 Aamic Ab Optiskt testsystem
SE528233C2 (sv) 2005-06-20 2006-09-26 Aamic Ab Metod och medel för att åstadkomma vätsketransport
US20090093968A1 (en) 2005-07-14 2009-04-09 Ryoko Kawamata Analysis device and analysis method
JP4581898B2 (ja) 2005-08-05 2010-11-17 パナソニック株式会社 試験片測定装置
CA2620079A1 (en) 2005-08-23 2007-03-01 Paul C. Harris Multi-directional immunochromatographic assays
US7829347B2 (en) * 2005-08-31 2010-11-09 Kimberly-Clark Worldwide, Inc. Diagnostic test kits with improved detection accuracy
US8116740B2 (en) 2005-09-21 2012-02-14 Nokia Corporation Mobile communication terminal and method
EP1965212B1 (en) * 2005-10-31 2012-01-18 National University Corporation Hokkaido University Non-liquid phase type chemiluminescent enzyme immunoassay method and assay kit
US20070178450A1 (en) 2006-01-27 2007-08-02 Microphage (Tm) Incorporation Method and apparatus for determining level of microorganisms using bacteriophage
SE529711C2 (sv) 2006-03-22 2007-11-06 Aamic Ab Fluorescensläsare
GB2436616A (en) * 2006-03-29 2007-10-03 Inverness Medical Switzerland Assay device and method
US7618369B2 (en) 2006-10-02 2009-11-17 Abbott Diabetes Care Inc. Method and system for dynamically updating calibration parameters for an analyte sensor
US8224415B2 (en) 2009-01-29 2012-07-17 Abbott Diabetes Care Inc. Method and device for providing offset model based calibration for analyte sensor
SE531948C2 (sv) 2006-06-20 2009-09-15 Aamic Ab Analysanordning för vätskeprover innefattande filter i direkt kontakt med projektioner
ATE449966T1 (de) 2006-09-15 2009-12-15 Hoffmann La Roche Biochemische marker für akute lungenembolie
JP5026090B2 (ja) 2007-01-09 2012-09-12 浜松ホトニクス株式会社 免疫クロマト試験片の測定装置
ES2377112T3 (es) 2007-08-03 2012-03-22 B.R.A.H.M.S Gmbh Método para el diagnóstico de una infección bacteriana
JP2009047590A (ja) 2007-08-21 2009-03-05 Aisin Seiki Co Ltd 濃度測定用イムノクロマトデバイス及びその濃度測定用イムノクロマトデバイスを用いた濃度測定方法
EP2212698B1 (en) 2007-11-14 2014-01-08 Nigel Robert Caterer Methods of quantification for lateral flow devices
WO2009075894A1 (en) * 2007-12-13 2009-06-18 Beckman Coulter, Inc Device and methods for detecting a target cell
JP5117939B2 (ja) 2008-06-24 2013-01-16 株式会社生体分子計測研究所 生体分子検査装置、生体分子検査チップ、生体分子検査方法、及び生体分子検査プログラム
JP5166208B2 (ja) 2008-10-28 2013-03-21 シスメックス株式会社 検体分析装置、検体分析装置の校正方法及びコンピュータプログラム
JP2010117290A (ja) 2008-11-14 2010-05-27 Panasonic Corp 液体試料成分の分析装置および分析方法
EP2478369A4 (en) 2009-03-25 2012-11-14 Lyzer Diagnostics Inc APPARATUS AND METHODS FOR ANALYZING VARIABLES RELATED TO FLUIDS
EP2616797B1 (en) * 2010-09-15 2017-01-11 MBIO Diagnostics Inc. System and method for detecting multiple molecules in one assay

Also Published As

Publication number Publication date
RU2015121732A (ru) 2017-01-10
EP2920591A1 (en) 2015-09-23
US20180156791A1 (en) 2018-06-07
CA2891509A1 (en) 2014-05-22
IN2015DN04062A (US07794700-20100914-C00194.png) 2015-10-09
CN104937418A (zh) 2015-09-23
EP2920591A4 (en) 2016-10-19
CN110412265A (zh) 2019-11-05
US11287424B2 (en) 2022-03-29
BR112015011040A2 (pt) 2017-07-11
CN110412265B (zh) 2023-04-11
JP2016500154A (ja) 2016-01-07
WO2014078679A1 (en) 2014-05-22
US9885712B2 (en) 2018-02-06
CA2891509C (en) 2021-05-11
CN104937418B (zh) 2019-08-23
US20140134653A1 (en) 2014-05-15

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