CN105637365B - 对多组分被分析物的校准 - Google Patents

对多组分被分析物的校准 Download PDF

Info

Publication number
CN105637365B
CN105637365B CN201480027599.6A CN201480027599A CN105637365B CN 105637365 B CN105637365 B CN 105637365B CN 201480027599 A CN201480027599 A CN 201480027599A CN 105637365 B CN105637365 B CN 105637365B
Authority
CN
China
Prior art keywords
calibration
analyte
signal
analyzer
components
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
CN201480027599.6A
Other languages
English (en)
Chinese (zh)
Other versions
CN105637365A (zh
Inventor
W.克莱德
H-D.克雷默
P.斯卢卡
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.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
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 F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Publication of CN105637365A publication Critical patent/CN105637365A/zh
Application granted granted Critical
Publication of CN105637365B publication Critical patent/CN105637365B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00693—Calibration
    • 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
    • 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
    • G01N33/5308—Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00693—Calibration
    • G01N2035/00702—Curve-fitting; Parameter matching; Calibration constants
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/59—Transmissivity
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00—Features of devices classified in G01N21/00
    • G01N2201/12—Circuits of general importance; Signal processing
    • G01N2201/127—Calibration; base line adjustment; drift compensation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4737—C-reactive protein
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Quality & Reliability (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Electrochemistry (AREA)
CN201480027599.6A 2013-06-07 2014-06-04 对多组分被分析物的校准 Active CN105637365B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13171044.4A EP2811300A1 (en) 2013-06-07 2013-06-07 Calibration for multi-component assays
EP13171044.4 2013-06-07
PCT/EP2014/061571 WO2014195355A1 (en) 2013-06-07 2014-06-04 Calibration for multi-component assays

Publications (2)

Publication Number Publication Date
CN105637365A CN105637365A (zh) 2016-06-01
CN105637365B true CN105637365B (zh) 2018-04-24

Family

ID=48578854

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201480027599.6A Active CN105637365B (zh) 2013-06-07 2014-06-04 对多组分被分析物的校准

Country Status (7)

Country Link
US (1) US11378573B2 (enExample)
EP (2) EP2811300A1 (enExample)
JP (1) JP6419791B2 (enExample)
CN (1) CN105637365B (enExample)
CA (1) CA2904256C (enExample)
ES (1) ES2768198T3 (enExample)
WO (1) WO2014195355A1 (enExample)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2900201C (en) * 2014-08-25 2025-01-07 Bio Rad Laboratories Inc VALUE ASSIGNMENT TO CUSTOMIZABLE QUALITY CONTROLS
CN108369387B (zh) 2015-12-17 2020-11-03 Asml荷兰有限公司 使用非对称亚分辨率特征改善测量的光刻过程的光学量测术
WO2017216208A1 (en) * 2016-06-15 2017-12-21 Roche Diagnostics Gmbh Improved d-dimer assay calibration
WO2018099859A1 (en) * 2016-12-02 2018-06-07 Roche Diagnostics Gmbh Failure state prediction for automated analyzers for analyzing a biological sample
US11209417B2 (en) * 2017-10-12 2021-12-28 Carrot, Inc. Breath sensor apparatus and methods of use
CN111239426B (zh) * 2018-11-29 2023-12-01 深圳市帝迈生物技术有限公司 样本分析仪及其自动校准的方法
GB2579810B (en) * 2018-12-14 2023-04-26 Aeirtec Ltd Assay Analysis
CN113474662A (zh) 2018-12-28 2021-10-01 贝克曼库尔特有限公司 临床分析仪自动化系统诊断
JP2020201174A (ja) * 2019-06-12 2020-12-17 国立研究開発法人物質・材料研究機構 スペクトル解析装置用の成分同定装置及びその方法、コンピュータプログラム
EP3757547B1 (en) * 2019-06-28 2022-11-23 ABB Schweiz AG Turbidity calibration-correction apparatus and method for an automated calibration correction
EP4078652A1 (en) * 2019-12-17 2022-10-26 F. Hoffmann-La Roche AG Method for calibrating at least one mass spectrometry device
JP7583812B2 (ja) * 2019-12-17 2024-11-14 エフ． ホフマン－ラ ロシュ アーゲー 複数の反復ハードウェア構成要素を有する少なくとも１つの分析装置を較正するための方法
EP4084684A4 (en) 2019-12-31 2024-03-27 McNeil AB METHOD AND DEVICE FOR CALIBRATION OF BREATH SENSORS
CN112462078A (zh) * 2020-11-16 2021-03-09 三诺生物传感股份有限公司 一种用于荧光免疫分析仪台间差校准的方法
CN112730203B (zh) * 2020-12-29 2023-06-16 深圳市科曼医疗设备有限公司 血球分析仪的光学系统、光学增益校准方法和存储介质
AU2022206320A1 (en) * 2021-01-11 2023-07-27 Meso Scale Technologies, Llc. Assay system calibration systems and methods

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6277584B1 (en) * 1998-12-16 2001-08-21 Dade Behring Inc. Method for calibrating a chemical analyzer with improved accuracy at low signal levels
EP0898169B1 (en) * 1997-08-11 2002-02-06 F. Hoffmann-La Roche Ag Microparticle enhanced light scattering assay and microparticle reagents therefor
EP0790500B1 (en) * 1996-01-09 2002-06-05 Fuji Photo Film Co., Ltd. Method of determining calibration curve and analysis method and apparatus using the same
EP1801590A1 (en) * 2004-08-31 2007-06-27 DENKA SEIKEN Co., Ltd. Method of assaying antigen and reagent therefor
CN102227639A (zh) * 2008-12-04 2011-10-26 积水医疗株式会社 人体液中的半胱氨酸蛋白酶抑制剂c的测定方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2244326C (en) * 1997-08-11 2006-03-28 Shinichi Eda Microparticle enhanced light scattering agglutination assay and microparticle reagents therefor
DE60334365D1 (de) * 2002-03-22 2010-11-11 Animas Technologies Llc Leistungsverbesserung einer analytenüberwachungsvorrichtung
JP2009063335A (ja) * 2007-09-05 2009-03-26 Fujifilm Corp 生理活性物質と被験物質との相互作用の測定方法
CN102216784B (zh) * 2008-11-17 2014-07-09 株式会社日立高新技术 自动分析装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0790500B1 (en) * 1996-01-09 2002-06-05 Fuji Photo Film Co., Ltd. Method of determining calibration curve and analysis method and apparatus using the same
EP0898169B1 (en) * 1997-08-11 2002-02-06 F. Hoffmann-La Roche Ag Microparticle enhanced light scattering assay and microparticle reagents therefor
US6277584B1 (en) * 1998-12-16 2001-08-21 Dade Behring Inc. Method for calibrating a chemical analyzer with improved accuracy at low signal levels
EP1801590A1 (en) * 2004-08-31 2007-06-27 DENKA SEIKEN Co., Ltd. Method of assaying antigen and reagent therefor
CN102227639A (zh) * 2008-12-04 2011-10-26 积水医疗株式会社 人体液中的半胱氨酸蛋白酶抑制剂c的测定方法

Also Published As

Publication number Publication date
WO2014195355A1 (en) 2014-12-11
HK1220758A1 (zh) 2017-05-12
ES2768198T3 (es) 2020-06-22
CN105637365A (zh) 2016-06-01
CA2904256A1 (en) 2014-12-11
US20160084861A1 (en) 2016-03-24
EP3004880B1 (en) 2019-11-20
US11378573B2 (en) 2022-07-05
CA2904256C (en) 2019-09-10
EP3004880A1 (en) 2016-04-13
JP2016523359A (ja) 2016-08-08
JP6419791B2 (ja) 2018-11-07
EP2811300A1 (en) 2014-12-10

Similar Documents

Publication Publication Date Title
CN105637365B (zh) 对多组分被分析物的校准
Cox et al. Immunoassay methods
Campbell et al. Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool
Clarke et al. Challenges in implementing clinical liquid chromatography–tandem mass spectrometry methods–seeing the light at the end of the tunnel
Dimech et al. Time to address quality control processes applied to antibody testing for infectious diseases
Jasensky et al. Evaluation of three different point‐of‐care tests for quantitative measurement of canine C‐reactive protein
Loh et al. Lot-to-lot variation and verification
Kofinova et al. Measuring protein‐protein interactions and quantifying their dissociation constants with mass photometry
Mondésert et al. A French multicenter analytical evaluation of the automated Lumipulse G sNfL blood assay (Fujirebio®) and its comparison to four other immunoassays for serum neurofilament light chain assessment in clinical settings
Given et al. Development and validation of an alpha fetoprotein immunoassay using Gyros technology
Meng et al. Serum triglyceride measurements: the commutability of reference materials and the accuracy of results
US9594088B2 (en) Multiple time windows with associated calibration curves for extending the range of an assay
CN117760760A (zh) 仪器状态确定方法、装置、计算机设备和存储介质
Ramamohan et al. Application of mathematical models of system uncertainty to evaluate the utility of assay calibration protocols
HK1220758B (en) Calibration for multi-component assays
Geertjens et al. A general framework for straightforward model construction of multi-component thermodynamic equilibrium systems
US8548935B2 (en) Predicting a future property using reagents by measuring properties at points in time
Leonard Immunoassay validation
Özcan et al. Impact of laboratory technician experience on the accuracy of laboratory test results in scientific research
Mao et al. Development of Absolute Quantification Methods for Digital Immunoassays: Theoretical Framework and Establishment of Droplet-Based Digital Immunoassay Techniques
Chen et al. Biomarker Assay Development, Qualification, and Validation
Rageade et al. Numerical simulations: will they become mandatory for better management of measurement process?
GB2457678A (en) Method for predicting a future property

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 1220758

Country of ref document: HK

GR01 Patent grant
GR01 Patent grant