EP0326100A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Ion-capture assays and devices
Assignee: Abbott Laboratories
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Filing: 1989-01-25
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Granted: —
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Expires: 2009-01-25
Abstract
Abstract This invention presents novel separation and assay procedures which allows both the indicator and the capture reagents to be in solution to avoid problems of slowed immunoreaction kinetics. The separation procedure involves an analyte-specific soluble capture reagent, that is conjugated to a charged substance, and an insoluble solid phase material that is oppositely charged. A fluid sample suspected of containing the analyte is mixed with the capture reagent in solution to form a charged capture reagent/analyte complex. When binding is complete, the solution is contacted to the oppositely charged solid phase material to attract, attach, and separate the capture reagent/analyte complex from the fluid sample. With the appropriate indicator reagent, i.e., a second analyte-specific binding substance which is conjugated to a label capable of producing a detectable signal, both sandwich and competitive assays can be performed. The assay reaction complex can be separated from the solution by contact with the oppositely charged solid phase material, and the presence or amount of analyte is monitored by detecting the label of the indicator reagent.
Inventors
- 👤 Robert G. Hiltibran
- 👤 Yi-Her Jou
- 👤 Steven J. Kline
- 👤 Steven George Schultz
- 👤 Stephen Denham Stroupe
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-24 04:39
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/536; G01N33/537; G01N33/538; G01N33/543; G01N33/54353; G01N33/54366; G01N33/544; G01N33/548; G01N33/558; G01N33/575; G01N33/57565
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
199 words
A process for detecting an analyte in a fluid sample, comprising: a) providing (1) a soluble capture reagent, comprising a first binding member specific for the analyte conjugated to a first charged substance, (2) a soluble indicator reagent, comprising a second binding member specific for the analyte conjugated to a label capable of producing a detectable signal, and (3) an insoluble solid phase material which is oppositely charged with respect to said first charged substance; b) contacting the fluid sample with said capture reagent, whereby said capture reagent becomes bound to the analyte in the sample, thereby forming a capture reagent/analyte complex; c) contacting said capture reagent/analyte complex with said indicator reagent, whereby said indicator reagent becomes bound to the analyte, thereby forming a capture reagent/analyte/indicator reagent sandwich complex; d) separating said sandwich complex from the sample by contacting the sample with said solid phase material, whereby said solid phase material attracts and attaches to said first charged substance of said sandwich complex, thereby separating said sandwich complex from the sample; and e) detecting said label associated with said solid phase or unbound indicator reagent as an indication of the presence or amount of the analyte in the sample.
Claim 2
Dependent Claim
199 words
A process for detecting an analyte in a fluid sample, comprising: a) providing (1) a soluble capture reagent, comprising a first binding member specific for the analyte conjugated to a first charged substance, (2) a soluble indicator reagent, comprising a second binding member specific for the analyte conjugated to a label capable of producing a detectable signal, and (3) an insoluble solid phase material which is oppositely charged with respect to said first charged substance; b) contacting the fluid sample with said capture reagent, whereby said capture reagent becomes bound to the analyte in the sample, thereby forming a capture reagent/analyte complex; c) contacting said capture reagent/analyte complex with said indicator reagent, whereby said indicator reagent becomes bound to the analyte, thereby forming a capture reagent/analyte/indicator reagent sandwich complex; d) separating said sandwich complex from the sample by contacting the sample with said solid phase material, whereby said solid phase material attracts and attaches to said first charged substance of said sandwich complex, thereby separating said sandwich complex from the sample; and e) detecting said label associated with said solid phase or unbound indicator reagent as an indication of the presence or amount of the analyte in the sample.
Claim 3
Dependent Claim
20 words
The process according to Claim 1, wherein said capture reagent and said indicator reagent are simultaneously contacted with fluid sample.
Claim 4
Dependent Claim
41 words
The process according to Claim 1, wherein at least one of said capture reagent and said indicator reagent is specific for at least one ancillary specific binding member, said ancillary specific binding member being necessary for formation of said sandwich complex.
Claim 5
Dependent Claim
179 words
A process for detecting an analyte in a fluid sample, comprising: a) providing (1) a soluble capture reagent comprising a first binding member specific for the analyte conjugated to a first charged substance, (2) a soluble indicator reagent, comprising a second binding member specific for the first binding member conjugated to a label capable of producing a detectable signal, and (3) an insoluble solid phase material which is oppositely charged with respect to said first charged substance; b) contacting the fluid sample with said capture reagent and said indicator reagent, whereby the analyte in the sample competes with said indicator reagent to bind to said capture reagent, thereby forming capture reagent/analyte complex and capture reagent/indicator complex; c) separating said complexes from the sample by contacting the sample with said solid phase material, whereby said solid phase material attracts and attaches to said first charged substance, thereby separating said complexes from the sample; and d) detecting said label associated with said solid phase or unbound indicator reagent as an indication of the presence or amount of analyte in the sample.
Claim 6
Dependent Claim
179 words
A process for detecting an analyte in a fluid sample, comprising: a) providing (1) a soluble capture reagent comprising a first binding member specific for the analyte conjugated to a first charged substance, (2) a soluble indicator reagent, comprising a second binding member specific for the first binding member conjugated to a label capable of producing a detectable signal, and (3) an insoluble solid phase material which is oppositely charged with respect to said first charged substance; b) contacting the fluid sample with said capture reagent and said indicator reagent, whereby the analyte in the sample competes with said indicator reagent to bind to said capture reagent, thereby forming capture reagent/analyte complex and capture reagent/indicator complex; c) separating said complexes from the sample by contacting the sample with said solid phase material, whereby said solid phase material attracts and attaches to said first charged substance, thereby separating said complexes from the sample; and d) detecting said label associated with said solid phase or unbound indicator reagent as an indication of the presence or amount of analyte in the sample.
Claim 7
Dependent Claim
21 words
The process according the Claim 4 wherein said capture reagent and said indicator reagent are sequentially contacted to the fluid sample.
Claim 8
Dependent Claim
40 words
The process according to Claim 4, wherein at least one of said capture reagent and said indicator reagent is specific for at least one ancillary specific binding member, said ancillary specific binding member being necessary for formation of said complexes.
Claim 9
Dependent Claim
118 words
A process for separating an analyte from a fluid sample, comprising: a) providing (1) a soluble capture reagent comprising a binding member specific for the analyte conjugated to a first charged substance, and (2) an insoluble solid phase material which is oppositely charged with respect to said first charged substance; b) contacting the fluid sample with said capture reagent, whereby said capture reagent becomes bound to the analyte in the sample thereby forming a capture reagent/analyte complex; and c) separating said capture reagent/analyte complex from the sample by contacting the sample with said solid phase material, whereby said solid phase material attracts and attaches to said first charged substance, thereby separating said capture reagent/analyte complex from the sample.
Claim 10
Dependent Claim
118 words
A process for separating an analyte from a fluid sample, comprising: a) providing (1) a soluble capture reagent comprising a binding member specific for the analyte conjugated to a first charged substance, and (2) an insoluble solid phase material which is oppositely charged with respect to said first charged substance; b) contacting the fluid sample with said capture reagent, whereby said capture reagent becomes bound to the analyte in the sample thereby forming a capture reagent/analyte complex; and c) separating said capture reagent/analyte complex from the sample by contacting the sample with said solid phase material, whereby said solid phase material attracts and attaches to said first charged substance, thereby separating said capture reagent/analyte complex from the sample.
Claim 11
Dependent Claim
45 words
A process according to Claims 1, 4 and 7, wherein a second charged substance which is oppositely charged with respect to said first charged substance is retained on said solid phase material, wherein said second charged substance attracts and attaches to said first charged substance.
Claim 12
Dependent Claim
55 words
The process according to Claims 1, 4 and 7, further comprising, contacting the capture reagent with a second charged substance which is oppositely charged with respect to said first charged substance, wherein said second charged substance attracts and attaches to said first charged substance prior to contacting said capture reagent with said solid phase material.
Claim 13
Dependent Claim
24 words
The process according to Claim 8, wherein said first charged substance is an anionic substance and said second charged substance is a cationic substance.
Claim 14
Dependent Claim
34 words
The process according to Claims 1, 4 and 7 wherein a plurality of charged microparticles are retained by said solid phase material, said microparticles being oppositely charged with respect to said first charged substance.
Claim 15
Dependent Claim
33 words
The process according to Claims 1, 4 and 7, wherein said capture reagent is specific for at least one ancillary specific binding member, said ancillary specific binding member being specific for the analyte.
Claim 16
Dependent Claim
80 words
A sandwich immunoassay kit for determining the presence or amount of an analyte in a fluid sample, comprising: a. a soluble capture reagent, comprising a first binding member specific for the analyte conjugated to a first charged substance; b. a soluble indicator reagent, comprising a second binding member specific for the analyte conjugated to a label capable of producing a detectable signal; and c. an insoluble solid phase material which is oppositely charged with respect to said first charged substance.
Claim 17
Dependent Claim
80 words
A sandwich immunoassay kit for determining the presence or amount of an analyte in a fluid sample, comprising: a. a soluble capture reagent, comprising a first binding member specific for the analyte conjugated to a first charged substance; b. a soluble indicator reagent, comprising a second binding member specific for the analyte conjugated to a label capable of producing a detectable signal; and c. an insoluble solid phase material which is oppositely charged with respect to said first charged substance.
Claim 18
Dependent Claim
81 words
A competitive immunoassay kit for determining the presence or amount of an analyte in a fluid sample, comprising: a. a soluble capture reagent, comprising a first binding member specific for the analyte conjugated to a first charged substance; b. a soluble indicator reagent, comprising a second binding member specific for the capture reagent conjugated to a label capable of producing a detectable signal; and c. an insoluble solid phase material which is oppositely charged with respect to said first charged substance.
Claim 19
Dependent Claim
81 words
A competitive immunoassay kit for determining the presence or amount of an analyte in a fluid sample, comprising: a. a soluble capture reagent, comprising a first binding member specific for the analyte conjugated to a first charged substance; b. a soluble indicator reagent, comprising a second binding member specific for the capture reagent conjugated to a label capable of producing a detectable signal; and c. an insoluble solid phase material which is oppositely charged with respect to said first charged substance.
Claim 20
Dependent Claim
36 words
The kit according to Claims 13 and 14, further comprising a second charged substance which is oppositely charged with respect to said first charged substance, said second charged substance being retained on said solid phase material.
Claim 21
Dependent Claim
38 words
A compound comprising a specific binding member conjugated to a charged substance, and second charged substance which is oppositely charged with respect to said first charged substance, said first and second substances being ionically bound to each other.
Claim 22
Dependent Claim
38 words
A compound comprising a specific binding member conjugated to a charged substance, and second charged substance which is oppositely charged with respect to said first charged substance, said first and second substances being ionically bound to each other.
References Cited (Backward Citations)
No citation records indexed.
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