JP2013140182A - イムノアッセイのモニタリング - Google Patents
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- 238000003018 immunoassay Methods 0.000 title claims abstract description 124
- 238000012544 monitoring process Methods 0.000 title claims abstract description 40
- 239000012530 fluid Substances 0.000 claims abstract description 119
- 238000000034 method Methods 0.000 claims abstract description 71
- 230000008859 change Effects 0.000 claims description 16
- 238000012937 correction Methods 0.000 claims description 16
- 238000011534 incubation Methods 0.000 claims description 16
- 230000007613 environmental effect Effects 0.000 claims description 11
- 238000007689 inspection Methods 0.000 claims description 8
- 238000012360 testing method Methods 0.000 abstract description 69
- 238000001514 detection method Methods 0.000 abstract description 8
- 238000005259 measurement Methods 0.000 abstract description 5
- 238000012875 competitive assay Methods 0.000 abstract description 3
- 238000011161 development Methods 0.000 abstract 1
- 210000001124 body fluid Anatomy 0.000 description 10
- 239000003814 drug Substances 0.000 description 9
- 229940079593 drug Drugs 0.000 description 9
- 239000010839 body fluid Substances 0.000 description 8
- 239000003550 marker Substances 0.000 description 6
- 230000009471 action Effects 0.000 description 5
- 230000008569 process Effects 0.000 description 4
- 230000002250 progressing effect Effects 0.000 description 4
- 238000003556 assay Methods 0.000 description 3
- 230000000007 visual effect Effects 0.000 description 3
- 239000012491 analyte Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000027455 binding Effects 0.000 description 2
- 238000009739 binding Methods 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000003068 static effect Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000011144 upstream manufacturing Methods 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 1
- 238000002820 assay format Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 238000001454 recorded image Methods 0.000 description 1
- 238000002310 reflectometry Methods 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 210000004243 sweat Anatomy 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01D—MEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
- G01D21/00—Measuring or testing not otherwise provided for
- G01D21/02—Measuring two or more variables by means not covered by a single other subclass
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N11/00—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties
- G01N11/02—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties by measuring flow of the material
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54306—Solid-phase reaction mechanisms
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
- G01N33/54388—Immunochromatographic test strips based on lateral flow
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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Abstract
【解決手段】イムノアッセイをモニタリングする方法であって、イムノアッセイ領域を横切る流体の流動端の位置を決定することを含む方法。この方法により、例えば、検査で起こりうるエラーの早期検出が可能になる。例えば、流体の流動端の移動速度を、検査中の各時点での流体の流動端の位置の測定から決定することができ、決定した移動速度を1つまたは複数の閾値と比較して、検査が正常に進行しているか否かを決定することができる。イムノアッセイをモニタリングする別の方法は、イムノアッセイ領域の基準区域の時間経過による変化をモニタリングすることを含む。これにより、検査が正常に進行しているか否かについての情報を早期にユーザに提供できる。この方法を用いて、検査の進行中に検査の条件を改善する方法を提供することもできる。この方法は、競合アッセイに適用することができる。
【選択図】図1
Description
イムノアッセイ領域を横切る流体の流動端(flow edge)の位置を決定することと、
イムノアッセイ領域を横切る流体の流動端の位置の時間経過による変化を表すパラメータの値を決定することと、
このパラメータの値からイムノアッセイの質についての情報を取得することと、を含む。
Claims (22)
- イムノアッセイの質をモニタリングする方法であって、
イムノアッセイ領域を横切る流体の流動端の位置を決定する工程と、
前記イムノアッセイ領域を横切る前記流体の流動端の位置の時間経過による変化を表すパラメータの値を決定する工程と、
前記パラメータの値から前記イムノアッセイの質についての情報を取得することと、を含む方法。 - 前記決定されたパラメータの値から前記検査の性能に対する補正を得ることを含む、請求項1に記載の方法。
- 前記決定されたパラメータの値を基準値と比較することを含む、請求項1または2に記載の方法。
- 前記決定されたパラメータの値を基準値と比較する前記ことにおいて、少なくとも1つの環境因子を考慮することを含む、請求項3に記載の方法。
- 前記少なくとも1つの環境因子が周囲温度を含む、請求項4に記載の方法。
- 前記少なくとも1つの環境因子が周囲湿度を含む、請求項4または5に記載の方法。
- 前記少なくとも1つの環境因子が、前記イムノアッセイ領域の傾斜を含む、請求項4、5、または6に記載の方法。
- 参照表を用いて前記補正を得ることを含む、請求項2に記載の方法。
- 前記パラメータが、前記流体の流動端の移動が検出される前の時間、前記流体の流動端の移動速度、前記流体の流動端の移動速度の変化、および前記流体の流動端が前記イムノアッセイ領域を横切る時間からなる群から選択される、請求項1〜8のいずれか1項に記載の方法。
- 前記イムノアッセイ領域を横切る前記流体の流動端の移動の開始を決定することを含む、請求項1〜9のいずれか1項に記載の方法。
- 前記流体の流動端が前記イムノアッセイ領域の活性部分の境界にいつ達するかを決定することをさらに含む、請求項1〜10のいずれか1項に記載の方法。
- 前記イムノアッセイのインキュベーション時間の決定に、前記流体の流動端が前記境界に達するまでの観察時間を考慮に入れることを含む、請求項10に記載の方法。
- 前記流体の流動端の形状をモニタリングすることをさらに含む、請求項1〜12のいずれか1項に記載の方法。
- 前記イムノアッセイ領域の流体を含む部分の時間経過による変化をモニタリングすることを含む、請求項1に記載の方法。
- 別のイムノアッセイ領域を横切る前記流体の流動端の位置を決定することをさらに含む、請求項1〜14のいずれか1項に記載の方法。
- 前記イムノアッセイ領域を横切る前記流体の流動端の移動速度を、前記別のイムノアッセイ領域を横切る前記流体の流動端の移動速度と比較することを含む、請求項15に記載の方法。
- 前記イムノアッセイ領域を横切る前記流体の流動端の移動時間を、前記別のイムノアッセイ領域を横切る前記流体の流動端の移動時間と比較することを含む、請求項15に記載の方法。
- イムノアッセイをモニタリングする方法において、
イムノアッセイ領域を横切る流体の流動端の形状をモニタリングすることを含む、方法。 - 前記決定した流体の流動端の形状を基準形状と比較することを含む、請求項18に記載の方法。
- イムノアッセイの質をモニタリングする方法において、
イムノアッセイ領域の基準区域の時間経過による変化をモニタリングすることを含む、方法。 - 前記基準区域の決定したパラメータを所定閾値と比較することを含む、請求項20に記載の方法。
- 請求項1〜21のいずれか1項に記載の方法を実施できるように適合されたイムノアッセイリーダー。
Applications Claiming Priority (2)
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GB0711932.4 | 2007-06-20 | ||
GB0711932.4A GB2450351B (en) | 2007-06-20 | 2007-06-20 | Monitoring an Immunoassay |
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JP2010512778A Division JP5341074B2 (ja) | 2007-06-20 | 2008-06-19 | イムノアッセイの質をモニタリングする方法及びイムノアッセイリーダー |
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JP2013086550A Pending JP2013140182A (ja) | 2007-06-20 | 2013-04-17 | イムノアッセイのモニタリング |
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Country Status (9)
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US (4) | US9360478B2 (ja) |
EP (1) | EP2176663B1 (ja) |
JP (2) | JP5341074B2 (ja) |
CN (2) | CN101779125B (ja) |
AU (1) | AU2008264991B2 (ja) |
GB (1) | GB2450351B (ja) |
HK (1) | HK1126553A1 (ja) |
NZ (1) | NZ582704A (ja) |
WO (1) | WO2008155579A1 (ja) |
Cited By (1)
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GB2450351B (en) | 2007-06-20 | 2012-01-18 | Cozart Bioscience Ltd | Monitoring an Immunoassay |
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US20200018676A1 (en) | 2020-01-16 |
US9360478B2 (en) | 2016-06-07 |
CN101779125B (zh) | 2017-04-12 |
AU2008264991B2 (en) | 2013-08-29 |
JP2010530534A (ja) | 2010-09-09 |
WO2008155579A1 (en) | 2008-12-24 |
US10473572B2 (en) | 2019-11-12 |
HK1126553A1 (en) | 2009-09-04 |
EP2176663A1 (en) | 2010-04-21 |
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US11988586B2 (en) | 2024-05-21 |
JP5341074B2 (ja) | 2013-11-13 |
GB2450351A (en) | 2008-12-24 |
CN106052750B (zh) | 2020-02-14 |
AU2008264991A1 (en) | 2008-12-24 |
US20100206055A1 (en) | 2010-08-19 |
GB2450351B (en) | 2012-01-18 |
CN101779125A (zh) | 2010-07-14 |
GB0711932D0 (en) | 2007-08-01 |
EP2176663B1 (en) | 2018-04-18 |
CN106052750A (zh) | 2016-10-26 |
NZ582704A (en) | 2012-06-29 |
US10928288B2 (en) | 2021-02-23 |
US20160252441A1 (en) | 2016-09-01 |
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