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US4254082A
Expired / Lapsed
US
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Specific binding-adsorbent assay test means
Assignee: Bayer Corp
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Filing: 1978-06-12
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Granted: 1981-03-03
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Expires: 1998-06-12
Abstract
Abstract A method and test means for determining a specific binding substance, such as an antigen or hapten, in a liquid sample wherein a solid, nonspecific adsorbent is contacted, preferably in sequence, with the sample and a labeled form of a binding partner for the substance to be determined, such as a labeled antibody. The amount of label which becomes associated with the adsorbent by binding of the labeled binding partner to the adsorbed substance to be determined, i.e., in a sandwich fashion, is a function of the amount of the substance to be determined in the liquid sample. Preferably, the adsorbent is an ion exchange material, and the assay steps are carried out under pH conditions between the isoelectric points (pI values) of the substance to be determined and the labeled binding partner. The method and test means are particularly suited for the detection of hepatitis B surface (HBs) antigen, especially where the label is a radioactive material and a column format is employed. The resultant radioimmunoadsorbent (RI-AdTM) assay and test means for HBs antigen offers significant manufacturing and user advantages over the prior art methods and test means.
Inventors
- 👤 Lloyd A. Schick
- 👤 Stephen K. Carpenter
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 15:15
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; Y; Y10; Y10S; Y10S436/00; Y10S436/804; Y10S436/82
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
87 words
Test means for determining a specific binding substance in a liquid sample comprising (a) a labeled specific binding partner for said substance having a pI value different from that of said substance; (b) a solid ion exchange adsorbent (i) of an anionic type when the pI value of said substance to be determined is less than that of said labeled binding partner, or (ii) of a cationic type when the pI value of said substance to be determined is greater than that of said labeled binding partner.
Claim 2
Dependent Claim
87 words
Test means for determining a specific binding substance in a liquid sample comprising (a) a labeled specific binding partner for said substance having a pI value different from that of said substance; (b) a solid ion exchange adsorbent (i) of an anionic type when the pI value of said substance to be determined is less than that of said labeled binding partner, or (ii) of a cationic type when the pI value of said substance to be determined is greater than that of said labeled binding partner.
Claim 3
Dependent Claim
35 words
Test means as in claim 1 which additionally comprises a liquid for washing said adsorbent having a pH between the pI value of said substance to be determined and that of said labeled binding partner.
Claim 4
Dependent Claim
17 words
Test means as in claim 1 wherein said specific binding partner is labeled with a radioactive material.
Claim 5
Dependent Claim
22 words
Test means as in claim 1 wherein said ion exchange material is in a particulate form and is contained in a column.
Claim 6
Dependent Claim
51 words
Test means for detecting hepatitis B surface antigen in a sample of serum or plasma, comprising (a) a solid anion exchange material; (b) labeled antibody to hepatitis B surface antigen having a pI value greater than about 8; and (c) a wash liquid having a pH of between 5 and 8.
Claim 7
Dependent Claim
51 words
Test means for detecting hepatitis B surface antigen in a sample of serum or plasma, comprising (a) a solid anion exchange material; (b) labeled antibody to hepatitis B surface antigen having a pI value greater than about 8; and (c) a wash liquid having a pH of between 5 and 8.
Claim 8
Dependent Claim
15 words
Test means as in claim 5 wherein said antibody is labeled with a radioactive material.
Claim 9
Dependent Claim
15 words
Test means as in claim 5 wherein said anion exchange material is a diethylaminoethyl-substituted cellulose.
Claim 10
Dependent Claim
16 words
Test means as in claim 5 wherein said anion exchange material is in a particulate form.
Claim 11
Dependent Claim
17 words
Test means as in claim 8 wherein said particulate anion exchange material is contained in a column.
Claim 12
Dependent Claim
15 words
Test means as in claim 5 wherein said anion exchange material is a diethylaminoethyl-substituted polymer.
Claim 13
Dependent Claim
12 words
Test means as in claim 10 wherein the polymer is a polysaccharide.
Claim 14
Dependent Claim
64 words
Test means for detecting hepatitis B surface antigen in a sample of serum or plasma, comprising (a) a column containing a particulate form of an anion exchange material equilibrated in a buffer having a pH of between 5 and 8; (b) a radiolabeled form of an antibody to hepatitis B surface antigen; and (c) a buffer having a pH of between 5 and 8.
Claim 15
Dependent Claim
64 words
Test means for detecting hepatitis B surface antigen in a sample of serum or plasma, comprising (a) a column containing a particulate form of an anion exchange material equilibrated in a buffer having a pH of between 5 and 8; (b) a radiolabeled form of an antibody to hepatitis B surface antigen; and (c) a buffer having a pH of between 5 and 8.
Claim 16
Dependent Claim
13 words
Test means as in claim 12 wherein said anion exchange material is DEAE-cellulose.
Claim 17
Dependent Claim
12 words
Test means as in claim 12 wherein said buffers are phosphate buffers.
Claim 18
Dependent Claim
14 words
Test means as in claim 12 wherein said antibody is labeled with 125 I.
Claim 19
Dependent Claim
33 words
Test means as in claim 12, capable of detecting hepatitis B surface antigen in the form of its immune complex with an antibody which additionally comprises a solution of an immunochemical-bond weakening agent.
Claim 20
Dependent Claim
13 words
Test means as in claim 16 wherein said anion exchange material is DEAE-cellulose.
Claim 21
Dependent Claim
15 words
Test means as in claim 17 wherein said bond weakening agent is a chaotropic agent.
Claim 22
Dependent Claim
15 words
Test means as in claim 18 wherein said chaotropic agent is urea, guanidine, or thiocyanate.
Claim 23
Dependent Claim
12 words
Test means as in claim 18 wherein said chaotropic agent is urea.
Claim 24
Dependent Claim
13 words
Test means as in claim 20 wherein said anion exchange material is DEAE-cellulose.
Claim 25
Dependent Claim
21 words
Test means as in claim 21 wherein said urea solution contains urea at a concentration of between 2 and 8 molar.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1984-03-02 | 1984-09-01 | 1985-03-03 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1988-03-02 | 1988-09-01 | 1989-03-03 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1992-03-02 | 1992-09-01 | 1993-03-03 | $7700.00 | Window Closed / Lapsed |