WO2008155579A1 - Monitoring an immunoassay - Google Patents
Monitoring an immunoassay Download PDFInfo
- Publication number
- WO2008155579A1 WO2008155579A1 PCT/GB2008/050466 GB2008050466W WO2008155579A1 WO 2008155579 A1 WO2008155579 A1 WO 2008155579A1 GB 2008050466 W GB2008050466 W GB 2008050466W WO 2008155579 A1 WO2008155579 A1 WO 2008155579A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- immunoassay
- fluid
- flow edge
- test
- monitoring
- Prior art date
Links
Classifications
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
Definitions
- a sample of bodily fluid such as blood, sweat, urine or saliva
- an immunoassay region which is normally in the form of a strip, and is drawn along the strip by capillary action.
- One zone of the strip at or near the upstream end of the strip, contains an antibody for a particular drug labelled (conjugated) with a suitable marker.
- the particular drug will, if it is present in the sample of bodily fluid, bind with the antibody.
- the strip further comprises one or more active zones which contain a drug-protein derivative specific to the drug that is being tested for.
- a typical immunoassay strip further includes a control region at or near its downstream end.
- a control region at or near its downstream end.
- a known reaction leading to a visible indication for example a colour change.
- a visible indication for example a colour change.
- the visible indication occurs in the control zone, this indicates that the sample of fluid has passed along the length of the strip to the control zone and that the test has been successfully run.
- the visible indication in the control zone may also be used in calibrating the results obtained in the various active zones of the strip.
- the determined value of the parameter could be input to a look-up table which outputs one or more desired correction factors to the test.
- a look-up table which outputs one or more desired correction factors to the test.
- one possible correction that may be made is to adjust the value of the incubation time and, in such a case, values of the incubation time may be stored in a look-up table, with the measured value of the parameter being input to the look-up table to determine the appropriate incubation time.
- Possible parameters that may be used in a method of the present invention include, but are not limited to, the time before movement of the flow edge of fluid is detected, speed of movement of the fluid flow edge across the immunoassay region, a change in speed of movement of the fluid flow edge, and the total time required for the fluid flow edge to cross the immunoassay region.
- Other parameters that may be used include the shape of flow edge of the fluid, and the variation in time of the area of the test strip in which flow is present and the area of the test strip in which flow is not present, as these may provide more information than a more simple measurement of the position of the flow edge.
- the description of taking at least one environmental factor into account is with particular reference to the observed speed of movement of the fluid flow edge, it is generally preferable to compensate for environmental factors such as temperature and/or humidity and/or tilt of the reader when the invention makes use of parameters other than the speed of movement of the fluid flow edge.
- the determined parameter representing the variation with time of the fluid flow edge is not compared with one or more thresholds but is input into a look-up table to obtain a correction, it is again preferable that the parameter is corrected for factors such as temperature and/or humidity and/or tilt of the reader before being input into the look-up table.
- the look-up table may store details of the required correction against one or more environmental parameter as well as against the parameter representing variation with time of the position of the flow edge of fluid - in this case, the value of the environmental parameter(s) are also input into the look-up table.
- Figure 1 shows only one embodiment of the present invention, and many other variations are possible. For example, it would be possible to perform the step of determining the shape of the fluid flow edge independently of the step of measuring the speed of movement of the fluid flow edge.
Abstract
Description
Claims
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08762574.5A EP2176663B1 (en) | 2007-06-20 | 2008-06-19 | Monitoring an immunoassay |
CN200880103289.2A CN101779125B (en) | 2007-06-20 | 2008-06-19 | monitoring an immunoassay |
NZ582704A NZ582704A (en) | 2007-06-20 | 2008-06-19 | Monitoring an immunoassay |
US12/665,501 US9360478B2 (en) | 2007-06-20 | 2008-06-19 | Monitoring an immunoassay |
JP2010512778A JP5341074B2 (en) | 2007-06-20 | 2008-06-19 | Method for monitoring immunoassay quality and immunoassay reader |
AU2008264991A AU2008264991B2 (en) | 2007-06-20 | 2008-06-19 | Monitoring an immunoassay |
US15/150,791 US10473572B2 (en) | 2007-06-20 | 2016-05-10 | Monitoring an immunoassay |
US16/580,354 US10928288B2 (en) | 2007-06-20 | 2019-09-24 | Monitoring an immunoassay |
US17/175,801 US20210239587A1 (en) | 2007-06-20 | 2021-02-15 | Monitoring an immunoassay |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0711932.4 | 2007-06-20 | ||
GB0711932.4A GB2450351B (en) | 2007-06-20 | 2007-06-20 | Monitoring an Immunoassay |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/665,501 A-371-Of-International US9360478B2 (en) | 2007-06-20 | 2008-06-19 | Monitoring an immunoassay |
US15/150,791 Continuation US10473572B2 (en) | 2007-06-20 | 2016-05-10 | Monitoring an immunoassay |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2008155579A1 true WO2008155579A1 (en) | 2008-12-24 |
Family
ID=38352575
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2008/050466 WO2008155579A1 (en) | 2007-06-20 | 2008-06-19 | Monitoring an immunoassay |
Country Status (9)
Country | Link |
---|---|
US (4) | US9360478B2 (en) |
EP (1) | EP2176663B1 (en) |
JP (2) | JP5341074B2 (en) |
CN (2) | CN101779125B (en) |
AU (1) | AU2008264991B2 (en) |
GB (1) | GB2450351B (en) |
HK (1) | HK1126553A1 (en) |
NZ (1) | NZ582704A (en) |
WO (1) | WO2008155579A1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2011209036A (en) * | 2010-03-29 | 2011-10-20 | Fujifilm Corp | Measuring instrument |
JP2015215355A (en) * | 2010-02-23 | 2015-12-03 | ベー.エル.アー.ハー.エム.エス ゲゼルシャフト ミット ベシュレンクテル ハフツング | Method for determining marker in small amount of body fluid sample |
US9939438B2 (en) | 2012-10-23 | 2018-04-10 | Robert Bosch Gmbh | Sensor integration in lateral flow immunoassays and its applications |
US10509031B2 (en) | 2012-11-15 | 2019-12-17 | Ortho-Clinical Diagnostics, Inc. | Quality/process control of a lateral flow assay device based on flow monitoring |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
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GB2450351B (en) * | 2007-06-20 | 2012-01-18 | Cozart Bioscience Ltd | Monitoring an Immunoassay |
AU2008207371B2 (en) * | 2007-09-01 | 2014-05-22 | Abbott Rapid Diagnostics International Unlimited Company | Assay device with shared zones |
GB2460660B (en) | 2008-06-04 | 2013-05-22 | Alere Switzerland Gmbh | Assay reader device & method for measuring hCG |
GB2483077A (en) | 2010-08-25 | 2012-02-29 | Concateno Uk Ltd | Sample testing assay apparatus and method |
DK2609416T3 (en) | 2010-08-26 | 2023-08-07 | Charm Sciences Inc | Analysis of the lateral flow assay |
WO2014126918A1 (en) | 2013-02-12 | 2014-08-21 | Charm Sciences, Inc. | Assessing assay analysis development |
GB201312998D0 (en) * | 2013-07-19 | 2013-09-04 | Cambridge temperature concepts ltd | Acquiring reliable data |
US10101342B2 (en) * | 2014-02-12 | 2018-10-16 | Church & Dwight Co., Inc. | Devices and methods for electronic analyte assaying |
ES2879813T3 (en) * | 2015-09-04 | 2021-11-23 | Qualigen Inc | Systems and procedures for sample verification |
CN110268266B (en) * | 2017-02-08 | 2022-11-29 | 富士胶片株式会社 | Immunity inspection device |
TW202321665A (en) * | 2019-01-07 | 2023-06-01 | 美商伊路米納有限公司 | System and method for detecting and analyzing fluid |
GB202019775D0 (en) * | 2020-12-15 | 2021-01-27 | Ams Int Ag | Lateral Flow Test Device |
US20230204266A1 (en) * | 2021-12-29 | 2023-06-29 | Christopher Franzese | Tracker for monitoring a discharge of a fluid from a tank |
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US20100206055A1 (en) | 2010-08-19 |
JP5341074B2 (en) | 2013-11-13 |
CN101779125B (en) | 2017-04-12 |
US20200018676A1 (en) | 2020-01-16 |
AU2008264991A1 (en) | 2008-12-24 |
AU2008264991B2 (en) | 2013-08-29 |
EP2176663A1 (en) | 2010-04-21 |
CN101779125A (en) | 2010-07-14 |
EP2176663B1 (en) | 2018-04-18 |
CN106052750B (en) | 2020-02-14 |
US9360478B2 (en) | 2016-06-07 |
US10473572B2 (en) | 2019-11-12 |
NZ582704A (en) | 2012-06-29 |
HK1126553A1 (en) | 2009-09-04 |
US10928288B2 (en) | 2021-02-23 |
US20210239587A1 (en) | 2021-08-05 |
JP2013140182A (en) | 2013-07-18 |
US20160252441A1 (en) | 2016-09-01 |
GB2450351B (en) | 2012-01-18 |
GB2450351A (en) | 2008-12-24 |
GB0711932D0 (en) | 2007-08-01 |
JP2010530534A (en) | 2010-09-09 |
CN106052750A (en) | 2016-10-26 |
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