US4594327A
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Assay method for whole blood samples
Assignee: Siemens Healthcare Diagnostics GmbH Germany
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Filing: 1983-11-02
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Granted: 1986-06-10
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Expires: 2003-11-02
Abstract
Abstract Methods and compositions are provided for performing an assay on whole blood samples. The method is for a determination of an analyte which is a member of a specific binding pair (sbp) consisting of ligand and homologous receptor. The method involves a binding agent for the red blood cells in such sample, a solid bibulous element to which is bound at least one sbp member, and a signal-producing system. The method comprises combining the whole blood sample, the binding agent, and none or, where appropriate, one or more members of the signal producing system. The medium is next contacted with a portion of a solid bibulous element to which is bound one of the members of the specific binding pair to allow the medium to traverse such element (immunochromatography). The solid bibulous element is contacted with any remaining members of the signal producing system. Signal resulting from the signal producing system is detected and is related to the amount of the analyte in the sample.
Inventors
- 👤 Robert F. Zuk
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 09:55
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/80; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/962; Y10S435/966; Y10S435/97; Y10S435/975; Y10S436/00; Y10S436/807; Y10S436/808; Y10S436/81; Y10S436/825; Y10S436/827
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
137 words
A method for determining an analyte in a whole blood sample, said analyte being a member of a specific binding pair ("sbp member") selected from the group consisting of ligand and homologous receptor, which method comprises-- contacting in an aqueous medium (A) a bibulous element, at a predetermined region of said element, said element having an sbp member substantially uniformly bound to the surface thereof with (B) a whole blood sample and (C) a binding agent for red blood cells present in said whole blood sample whereby said medium traverses said element to define a border related to the amount of analyte and said red blood cells aggregate at an area on said element adjacent to the air-liquid interface; and determining said border by means of a signal producing system, which system includes a labeled sbp member.
Claim 2
Independent Claim
137 words
A method for determining an analyte in a whole blood sample, said analyte being a member of a specific binding pair ("sbp member") selected from the group consisting of ligand and homologous receptor, which method comprises-- contacting in an aqueous medium (A) a bibulous element, at a predetermined region of said element, said element having an sbp member substantially uniformly bound to the surface thereof with (B) a whole blood sample and (C) a binding agent for red blood cells present in said whole blood sample whereby said medium traverses said element to define a border related to the amount of analyte and said red blood cells aggregate at an area on said element adjacent to the air-liquid interface; and determining said border by means of a signal producing system, which system includes a labeled sbp member.
Claim 3
Dependent Claim
13 words
The method of claim 1 wherein the binding agent is an agglutinating agent.
Claim 4
Dependent Claim
16 words
The method of claim 1 wherein the binding agent is antibody specific for red blood cells.
Claim 5
Dependent Claim
12 words
The method of claim 1 wherein the binding agent is a lectin.
Claim 6
Dependent Claim
14 words
The method of claim 1 wherein the binding agent is a polymeric amino acid.
Claim 7
Dependent Claim
11 words
The method of claim 1 wherein the binding agent is polylysine.
Claim 8
Dependent Claim
18 words
The method of claim 1 wherein the pH of said medium is in the range of about 6-10.
Claim 9
Dependent Claim
19 words
The method of claim 1 wherein the ionic strength of said medium is in the range of about 0.1-0.4.
Claim 10
Independent Claim
208 words
A method for detecting the presence of a member of a specific binding pair ("sbp member") in a whole blood sample, said sbp member selected from the group consisting of ligand and homologous receptor, where said method involves (1) a binding agent for red blood cells in said sample; (2) a solid bibulous element to which is bound at least one sbp member; and (3) a signal producing system capable of producing a detectable signal, the members of which include at least one label which is bound to an sbp member, said method comprising: (a) combining in an aqueous medium a whole blood sample, a binding agent for aggregating red blood cells in said sample, and fewer than all the members of the signal producing system, (b) contacting a portion of said bibulous carrier with said aqueous medium to allow said medium to diffuse along said bibulous element and said aggregated red blood cells to concentrate in an area on said element adjacent the air/liquid interface, (c) contacting said bibulous element with any remaining members of the signal producing system, and (d) detecting the signal as a result of said signal producing system, wherein said signal is related to the amount of said sbp member in said sample.
Claim 11
Independent Claim
208 words
A method for detecting the presence of a member of a specific binding pair ("sbp member") in a whole blood sample, said sbp member selected from the group consisting of ligand and homologous receptor, where said method involves (1) a binding agent for red blood cells in said sample; (2) a solid bibulous element to which is bound at least one sbp member; and (3) a signal producing system capable of producing a detectable signal, the members of which include at least one label which is bound to an sbp member, said method comprising: (a) combining in an aqueous medium a whole blood sample, a binding agent for aggregating red blood cells in said sample, and fewer than all the members of the signal producing system, (b) contacting a portion of said bibulous carrier with said aqueous medium to allow said medium to diffuse along said bibulous element and said aggregated red blood cells to concentrate in an area on said element adjacent the air/liquid interface, (c) contacting said bibulous element with any remaining members of the signal producing system, and (d) detecting the signal as a result of said signal producing system, wherein said signal is related to the amount of said sbp member in said sample.
Claim 12
Dependent Claim
17 words
The method of claim 9 wherein the binding agent is antibody specific for said red blood cells.
Claim 13
Dependent Claim
207 words
A kit for use in a method for determining an analyte in a whole blood sample, said analyte being a member of a specific binding pair ("sbp member") selected from the group consisting of ligand and homologous receptor, which method comprises-- contacting in an aqueous medium (a) a bibulous element, at a predetermined region of said element, said element having an sbp member substantially uniformly bound to the surface thereof with (b) said whole blood sample and (c) a binding agent for red blood cells present in said whole blood sample; whereby said medium traverses said element to define a border related to the amount of analyte and said red blood cells aggregate at a region on said element corresponding to the air-liquid interface; and determining said border by means of a signal producing system, which system includes a labeled sbp member; said kit comprising in a packaged combination in predetermined ratios for combination with said sample according to said method, (a) a binding agent specific for said red blood cells, (b) a bibulous element to which is bound at least one sbp member, and (c) a signal producing system capable of producing a detectable signal in relation to the amount of analyte present in said sample.
Claim 14
Dependent Claim
207 words
A kit for use in a method for determining an analyte in a whole blood sample, said analyte being a member of a specific binding pair ("sbp member") selected from the group consisting of ligand and homologous receptor, which method comprises-- contacting in an aqueous medium (a) a bibulous element, at a predetermined region of said element, said element having an sbp member substantially uniformly bound to the surface thereof with (b) said whole blood sample and (c) a binding agent for red blood cells present in said whole blood sample; whereby said medium traverses said element to define a border related to the amount of analyte and said red blood cells aggregate at a region on said element corresponding to the air-liquid interface; and determining said border by means of a signal producing system, which system includes a labeled sbp member; said kit comprising in a packaged combination in predetermined ratios for combination with said sample according to said method, (a) a binding agent specific for said red blood cells, (b) a bibulous element to which is bound at least one sbp member, and (c) a signal producing system capable of producing a detectable signal in relation to the amount of analyte present in said sample.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1989-06-09 | 1989-12-09 | 1990-06-10 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1993-06-09 | 1993-12-09 | 1994-06-10 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1997-06-09 | 1997-12-09 | 1998-06-10 | $7700.00 | Window Closed / Lapsed |