EP0421294A2
Expired / Lapsed
EP
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Improved self-performing immunochromatographic device
Assignee: Abbott Laboratories
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Filing: 1990-09-28
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Granted: —
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Expires: 2010-09-28
Abstract
Abstract Improved chromatographic strip binding assay devices are provided for determining the presence or amount of an analyte present in a patient sample. Assay label reagents interact with capture reagents immobilized in a testing region on the strip substrate to generate a visually detectable image indicative of the test result. The test result images include a minus sign (-) to indicate a negative test result for analyte which image is generated if the suspect analyte is absent in the patient sample and a plus sign (+) to indicate a positive test result for analyte which image is generated if the suspect analyte is present or is present at a pre-determined concentration in the patient sample. The immobilized capture reagents responsible for the location and configuration of the test result images are applied to the strip at an angled orientation with respect to the fluid flow direction of the strip to ensure that sharp substantially complete test result images are formed during performance of the assay. The devices provide substantially self-performing assays having inherently clear test results which are not subject to misinterpretation by the skilled or untrained user.
Inventors
- 👤 Eugene W. Osikowicz
- 👤 Russell B. Richerson
- 👤 Michael J. Beggs
- 👤 Frank J. Walsworth
- 👤 Paul P. Brookhart
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-07 12:27
CPC Classifications
G; G01; G01N; G01N30/00; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
260 words
A chromatographic strip binding assay device for detecting the presence or amount of an analyte present in a patient sample of the type which develops a visually detectable plus sign (+) to indicate a positive test result for analyte or a visually detectable minus sign (-) to indicate a negative test result for analyte, said device including: a chromatographic strip substrate having a length and narrow width capable of conveying fluids in a fluid flow direction generally parallel to the length of said strip, said strip including a sample contact region whereat a fluid patient sample and other assay reagents may be contacted with said strip and a testing region disposed on said strip at a downstream location from said sample contact region, said testing region including a patient test bar defined by a first capture reagent specific for the analyte being tested for immobilized on said strip testing region in a generally rectangular configuration and a procedural control bar defined by a second capture reagent specific for an assay label immobilized on said strip testing region in a generally rectangular configuration, said patient test bar and procedural control bar intersecting each other in a generally perpendicular manner at the testing region; and the test result imaging improvement comprising: said patient test bar and said procedural control bar each being immobilized on said strip testing region in an angled orientation with respect to the fluid flow direction of said strip to minimize the distance travelled by an added migrating fluid across both the patient test bar and procedural control bar.
Claim 2
Dependent Claim
260 words
A chromatographic strip binding assay device for detecting the presence or amount of an analyte present in a patient sample of the type which develops a visually detectable plus sign (+) to indicate a positive test result for analyte or a visually detectable minus sign (-) to indicate a negative test result for analyte, said device including: a chromatographic strip substrate having a length and narrow width capable of conveying fluids in a fluid flow direction generally parallel to the length of said strip, said strip including a sample contact region whereat a fluid patient sample and other assay reagents may be contacted with said strip and a testing region disposed on said strip at a downstream location from said sample contact region, said testing region including a patient test bar defined by a first capture reagent specific for the analyte being tested for immobilized on said strip testing region in a generally rectangular configuration and a procedural control bar defined by a second capture reagent specific for an assay label immobilized on said strip testing region in a generally rectangular configuration, said patient test bar and procedural control bar intersecting each other in a generally perpendicular manner at the testing region; and the test result imaging improvement comprising: said patient test bar and said procedural control bar each being immobilized on said strip testing region in an angled orientation with respect to the fluid flow direction of said strip to minimize the distance travelled by an added migrating fluid across both the patient test bar and procedural control bar.
Claim 3
Dependent Claim
40 words
A device as in Claim 1, wherein the angular orientations of the patient test bar and the procedural control bar with respect to the fluid flow direction are defined by complementary angles varying between about 30° to about 60°, respectively.
Claim 4
Dependent Claim
31 words
A device as in Claim 1, wherein the angled orientation of the patient test bar and the procedural control bar with respect to the fluid flow direction is about 45°, respectively.
Claim 5
Dependent Claim
13 words
A device as in Claim 1, wherein the chromatographic strip substrate comprises nitrocellulose.
Claim 6
Dependent Claim
19 words
A device as in Claim 1, wherein said first capture reagent comprises a specific binding pair member for analyte.
Claim 7
Dependent Claim
21 words
A device as in Claim 5, wherein first capture reagent is selected from the group comprising an antigen or an antibody.
Claim 8
Dependent Claim
20 words
A device as in Claim 1, wherein the second capture reagent comprises a specific binding pair member for assay label.
Claim 9
Dependent Claim
22 words
A device as in Claim 7, wherein the second capture reagent is selected from the group comprising an antigen or an antibody.
Claim 10
Dependent Claim
45 words
A device as in Claim 1 further comprising a housing for surrounding and holding the strip, said housing including a sample entry aperture disposed adjacent the sample entry region of the strip and a test result window disposed adjacent the testing region of said strip.
Claim 11
Dependent Claim
30 words
A device as in Claim 1 further comprising a conjugate pad including a porous pad substrate having an assay label therein disposed adjacent said strip at the sample entry region.
Claim 12
Dependent Claim
51 words
A device as in Claim 10, wherein said first capture reagent comprises an antibody specific for the analyte being tested for, said second capture reagent comprises immobilized analyte; and the assay label in the conjugate pad comprises an antibody specific for the analyte being tested for conjugated to a labelling substance.
Claim 13
Dependent Claim
15 words
A device as in Claim 11, wherein the labelling substance is a selenium colloid label.
Claim 14
Dependent Claim
55 words
A device as in Claim 10, wherein said first capture reagent comprises an antibody specific for the analyte being tested for, said second capture reagent comprises an antibody specific for assay label; and the assay label in the conjugate pad comprises an antibody specific for the analyte being tested for conjugated to a labelling substance.
Claim 15
Dependent Claim
15 words
A device as in Claim 13, wherein said labelling substance is a selenium colloid label.
Claim 16
Dependent Claim
71 words
A device as in Claim 1, further comprising an end of test indicator region on said strip at a downstream location from the testing region and defined by an indicator reagent capable of generating a visually detectable signal upon contact with any testing fluids to indicate that fluids have flowed to the end of test region and that the test result indicated at the testing region is a final test result.
Claim 17
Dependent Claim
16 words
A device as in Claim 11, wherein said second capture reagent comprises an immobilized antibody/analyte complex.
Claim 18
Dependent Claim
46 words
A device as in Claim 13, wherein said assay label comprises a monoclonal antibody from a first species specific for the analyte being tested for and said second capture reagent comprises an antibody from a second species specific for the monoclonal antibody of the first species.
Claim 19
Dependent Claim
29 words
A device as in Claim 17, wherein the assay label comprises a mouse monoclonal antibody specific for analyte and the second capture reagent comprises a specific anti-mouse IgG antibody.
References Cited (Backward Citations)
No citation records indexed.
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