CA2216214A1 - Single-device, multi-purposes membrane-based rapid immunoassay - Google Patents
Single-device, multi-purposes membrane-based rapid immunoassay Download PDFInfo
- Publication number
- CA2216214A1 CA2216214A1 CA002216214A CA2216214A CA2216214A1 CA 2216214 A1 CA2216214 A1 CA 2216214A1 CA 002216214 A CA002216214 A CA 002216214A CA 2216214 A CA2216214 A CA 2216214A CA 2216214 A1 CA2216214 A1 CA 2216214A1
- Authority
- CA
- Canada
- Prior art keywords
- membrane
- results
- purposes
- dots
- based rapid
- 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.)
- Abandoned
Links
- 239000012528 membrane Substances 0.000 title claims abstract description 26
- 238000003018 immunoassay Methods 0.000 title claims abstract description 8
- 238000000034 method Methods 0.000 abstract description 7
- 238000011045 prefiltration Methods 0.000 abstract description 6
- 239000002245 particle Substances 0.000 abstract description 4
- 102000003992 Peroxidases Human genes 0.000 abstract description 3
- 108040007629 peroxidase activity proteins Proteins 0.000 abstract description 3
- 210000000601 blood cell Anatomy 0.000 abstract description 2
- 238000002405 diagnostic procedure Methods 0.000 abstract description 2
- 239000012491 analyte Substances 0.000 description 10
- 238000002965 ELISA Methods 0.000 description 3
- 239000002250 absorbent Substances 0.000 description 2
- 230000002745 absorbent Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000012113 quantitative test Methods 0.000 description 2
- 102000002260 Alkaline Phosphatase Human genes 0.000 description 1
- 108020004774 Alkaline Phosphatase Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
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
- G01N33/543—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
- G01N33/54391—Immunochromatographic test strips based on vertical flow
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- Health & Medical Sciences (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
This invention is a method of developing a single device, multiple-purposes membrane based rapid immunoassay for diagnostic tests. By using biochemistry and immunology method, this invention can provide multiple results or semi-quantitative results in a single addition of sample. This invention is a device with a membrane which results can be interpreted visually by the pattern of the dots. This system uses peroxidase as the color developing system. By placing a pre-filter on the top of the reaction membrane, larger particles such as blood cells can be removed.
Description
Patent Application Date: January 7, 1999 Inventor: Jia Bei Zhu Address: 1629 Fosters Way Delta, BC., Canada Title: Single device, Multiple-Purposes , membrane based rapid immunoassay Abstract:
This invention is a method of developing a single device, multiple-purposes membrane based rapid immunoassay for diagnostic tests. By using biochemistry and immunology method, this invention oan provide multiple results or semi-quantitative results in a single addition of sample. This invention is a device with a membrane which results can be interpreted visually by the pattern of the dots. This system uses peroxidase as the color developing system. By placing a pre-filter on the top of the reaction membrane, larger particles such as blood cells can be removed.
Specification:
The membrane based rapid immunoassay provides a high sensitivity, fast and simple way of medical diagnosis. And it offers several advantages over the traditional enzyme linked immunosorbent assay (ELISA) method. As the technology of membrane and color developing system improve rapidly over the past few years, the use of membrane based immunoassay become more common.
For some application, the traditional color developing system using alkaline phosphatase or colloidal gold conjugate on membrane based system is not sensitive enough.
In this invention, horsedish peroxidase system is used and a pre-filter is located on the top of the reaction membrane.
Different ways of treatment is performed on the reaction membrane of the test kit during the manufacturing process. The dots and/or markers' pattern on the membrane are decided to give qualitative or semi-quantitative results. Sample is needed to add just once for either qualifying multiple analyte or semi-quantifying an analyte.
Comparing with ELISA method, no time-consuming and complicated lab procedures are required for conducting membrane based test kit.
' CA 02216214 1999-03-O1 In this invention, a pre-treated membrane is placed on an absorbent. A pre-filter is placed on the top of the membrane for separation of large particles. See figure 1.
During the test, sample is added onto the sample adding well (4), the purpose of the pre-filter( 1 ) is for large particles removal. Then the pre-filter is removed from the test kit and discard. Enzyme conjugate solution is then added onto the reaction membrane (2) and color developing solution is added. The absorbent underneath (3) is serve as a used liquid (sample and reagent) collection and also provides capillary action for the movement of the liquid through the membrane.
The treatment of the reaction membrane is depends on the function of the test kit.
Markers or/and dots of antigens or antibodies can be coated on the membrane to create patterns for different results. On a small piece of membrane (for cost reduction purpose, diameter of as small as l2mm can be used), for qualitative test kit, a dot or marker consists of the analyte,is coated for control purpose. One or more of the test dots) can be coated on for multiple items determination. For semi-quantitative test, a series of control dots ( consist of different concentration of the same analyte) are coated on the membrane so that the intensity of the color developing of each dot are directly proportional to the concentration of the analyte. By comparing the test dot with the control dots, semi-quantitative results canJ~e obtained from a single test kit.
For qualitative test, dots l,2,3,5,6 and 7 can be represented for six different analyte determination. The appearance of particular color dot after the test represents the positive result of the corresponding analyte. Dot 4 represents for the control dot. For semi-quantitative test format, dots 1,2,3,5,6 and 7 can be served as the internal control and the dot 4 is the test dot. During the interpretation of results, the color intensity of dot 4 (the test dot) is directly proportional to the concentration of the analyte and estimation of concentration can be obtained by comparing the test dot(dot4)q with the color intensity of the internal semi-quantitative control dots (Dots 1,2,3,5,6,and 7). The color intensity of dot l,2,3,5,6 and 7 is corresponding to different concentration of analyte and can be used as a internal reference for determination of the concentration of the analyte in the sample.
Claims:
The embodiments of the invention in which an exclusive property or privilege is claimed are defined as a single device, multi-purpose, membrane-based rapid immunoassay.
This invention is a method of developing a single device, multiple-purposes membrane based rapid immunoassay for diagnostic tests. By using biochemistry and immunology method, this invention oan provide multiple results or semi-quantitative results in a single addition of sample. This invention is a device with a membrane which results can be interpreted visually by the pattern of the dots. This system uses peroxidase as the color developing system. By placing a pre-filter on the top of the reaction membrane, larger particles such as blood cells can be removed.
Specification:
The membrane based rapid immunoassay provides a high sensitivity, fast and simple way of medical diagnosis. And it offers several advantages over the traditional enzyme linked immunosorbent assay (ELISA) method. As the technology of membrane and color developing system improve rapidly over the past few years, the use of membrane based immunoassay become more common.
For some application, the traditional color developing system using alkaline phosphatase or colloidal gold conjugate on membrane based system is not sensitive enough.
In this invention, horsedish peroxidase system is used and a pre-filter is located on the top of the reaction membrane.
Different ways of treatment is performed on the reaction membrane of the test kit during the manufacturing process. The dots and/or markers' pattern on the membrane are decided to give qualitative or semi-quantitative results. Sample is needed to add just once for either qualifying multiple analyte or semi-quantifying an analyte.
Comparing with ELISA method, no time-consuming and complicated lab procedures are required for conducting membrane based test kit.
' CA 02216214 1999-03-O1 In this invention, a pre-treated membrane is placed on an absorbent. A pre-filter is placed on the top of the membrane for separation of large particles. See figure 1.
During the test, sample is added onto the sample adding well (4), the purpose of the pre-filter( 1 ) is for large particles removal. Then the pre-filter is removed from the test kit and discard. Enzyme conjugate solution is then added onto the reaction membrane (2) and color developing solution is added. The absorbent underneath (3) is serve as a used liquid (sample and reagent) collection and also provides capillary action for the movement of the liquid through the membrane.
The treatment of the reaction membrane is depends on the function of the test kit.
Markers or/and dots of antigens or antibodies can be coated on the membrane to create patterns for different results. On a small piece of membrane (for cost reduction purpose, diameter of as small as l2mm can be used), for qualitative test kit, a dot or marker consists of the analyte,is coated for control purpose. One or more of the test dots) can be coated on for multiple items determination. For semi-quantitative test, a series of control dots ( consist of different concentration of the same analyte) are coated on the membrane so that the intensity of the color developing of each dot are directly proportional to the concentration of the analyte. By comparing the test dot with the control dots, semi-quantitative results canJ~e obtained from a single test kit.
For qualitative test, dots l,2,3,5,6 and 7 can be represented for six different analyte determination. The appearance of particular color dot after the test represents the positive result of the corresponding analyte. Dot 4 represents for the control dot. For semi-quantitative test format, dots 1,2,3,5,6 and 7 can be served as the internal control and the dot 4 is the test dot. During the interpretation of results, the color intensity of dot 4 (the test dot) is directly proportional to the concentration of the analyte and estimation of concentration can be obtained by comparing the test dot(dot4)q with the color intensity of the internal semi-quantitative control dots (Dots 1,2,3,5,6,and 7). The color intensity of dot l,2,3,5,6 and 7 is corresponding to different concentration of analyte and can be used as a internal reference for determination of the concentration of the analyte in the sample.
Claims:
The embodiments of the invention in which an exclusive property or privilege is claimed are defined as a single device, multi-purpose, membrane-based rapid immunoassay.
Claims
Claims:
The embodiments of the invention in which an exclusive property or privilege is claimed are defined as a single device, multi-purpose, membrane-based rapid immunoassay.
The embodiments of the invention in which an exclusive property or privilege is claimed are defined as a single device, multi-purpose, membrane-based rapid immunoassay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002216214A CA2216214A1 (en) | 1997-11-17 | 1997-11-17 | Single-device, multi-purposes membrane-based rapid immunoassay |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002216214A CA2216214A1 (en) | 1997-11-17 | 1997-11-17 | Single-device, multi-purposes membrane-based rapid immunoassay |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2216214A1 true CA2216214A1 (en) | 1999-05-17 |
Family
ID=29275053
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002216214A Abandoned CA2216214A1 (en) | 1997-11-17 | 1997-11-17 | Single-device, multi-purposes membrane-based rapid immunoassay |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2216214A1 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2427271A (en) * | 2005-06-16 | 2006-12-20 | Porvair Filtration Group Ltd | Diagnostic device |
| EP3187876A1 (en) * | 2011-01-18 | 2017-07-05 | Symbolics, LLC | Lateral flow assays using two dimensional features |
| US9874556B2 (en) | 2012-07-18 | 2018-01-23 | Symbolics, Llc | Lateral flow assays using two dimensional features |
-
1997
- 1997-11-17 CA CA002216214A patent/CA2216214A1/en not_active Abandoned
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2427271A (en) * | 2005-06-16 | 2006-12-20 | Porvair Filtration Group Ltd | Diagnostic device |
| GB2427272A (en) * | 2005-06-16 | 2006-12-20 | Porvair Filtration Group Ltd | Diagnostic device |
| US7354614B2 (en) | 2005-06-16 | 2008-04-08 | Porvair Filtration Group Ltd. | Diagnostic device |
| GB2427272B (en) * | 2005-06-16 | 2009-11-18 | Porvair Filtration Group Ltd | Immunochromatographic assay device and method |
| EP3187876A1 (en) * | 2011-01-18 | 2017-07-05 | Symbolics, LLC | Lateral flow assays using two dimensional features |
| US9851366B2 (en) | 2011-01-18 | 2017-12-26 | Symbolics, Llc | Lateral flow assays using two dimensional features |
| US9874576B2 (en) | 2011-01-18 | 2018-01-23 | Symbolics, Llc | Lateral flow assays using two dimensional features |
| US11016090B2 (en) | 2011-01-18 | 2021-05-25 | Symbolics, Llc | Lateral flow assays using two dimensional features |
| US9874556B2 (en) | 2012-07-18 | 2018-01-23 | Symbolics, Llc | Lateral flow assays using two dimensional features |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |