Patent US4968604A successfully refreshed from Google Patents.
US4968604A
Expired / Lapsed
US
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Method and test kit for detection of antibodies
Assignee: Poniard Pharmaceuticals Inc
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Filing: 1989-07-20
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Granted: 1990-11-06
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Expires: 2009-07-20
Abstract
Abstract Assay methods and test kits for detection of antibodies having specificities for a variety of determinants in patient samples are disclosed. The assay is especially suitable for use in evaluating patients for their suitability to receive diagnostic and therapeutic immunoconjugates comprising immunoglobulin constituents derived, at least in part, from a non-human source. The assay methods and test kits utilize a target substance (e.g., immunoglobulin) which has substantially the same binding characteristics as a portion of the immunoconjugate proposed for in vivo administration. A plurality of target substance densities are used for assaying each patient specimen to provide an indication of both the level and relative affinity of circulating antibody capable of binding to the immunoconjugate proposed for treatment. According to preferred embodiments, the assay utilizes a dipstick or test strip format wherein multiple densities of a target substance are bound to a support medium in a predetermined spatial relationship, preferably in a side-by-side relationship.
Inventors
- 👤 Shannon M. Beatty
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 08:52
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/521; G01N33/523; G01N33/68; G01N33/6854; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S436/00; Y10S436/807; Y10S436/808; Y10S436/809; Y10S436/81
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
57 words
A support medium having a plurality of densities of a target substance bound thereto in a predetermined spatial relationship, wherein said target substance bas binding characteristics similar to binding characteristics of a diagnostic or therapeutic substance proposed for in vivo administration to a patient to permit evaluation of said patient's response to said diagnostic or therapeutic substance.
Claim 2
Dependent Claim
57 words
A support medium having a plurality of densities of a target substance bound thereto in a predetermined spatial relationship, wherein said target substance bas binding characteristics similar to binding characteristics of a diagnostic or therapeutic substance proposed for in vivo administration to a patient to permit evaluation of said patient's response to said diagnostic or therapeutic substance.
Claim 3
Dependent Claim
18 words
A support medium according to claim 1, wherein said target substance is covalently bound to said support medium.
Claim 4
Dependent Claim
16 words
A support medium according to claim 1, wherein said predetermined spatial relationship is a side-by-side relationship.
Claim 5
Dependent Claim
30 words
A support medium according to claim 3, wherein said plurality of densities of said target substance provides a plurality of patient specimen test regions arranged in ascending order of density.
Claim 6
Dependent Claim
38 words
A support medium according to claim 1, wherein said target substance is a target immunoglobulin, and said target immunoglobulin has binding characteristics similar to binding characteristics of a carrier moiety of said immunoconjugate proposed for in vivo administration.
Claim 7
Dependent Claim
27 words
A support medium according to claim 5, wherein said target immunoglobulin and said carrier moiety are derived, at least in part, from the same species of origin.
Claim 8
Dependent Claim
26 words
A support medium according to claim 5, wherein specificity determining regions of said target immunoglobulin are identical to corresponding specificity determining regions of said carrier moiety.
Claim 9
Dependent Claim
25 words
A support medium according to claim 5, wherein said target immunoglobulin and said carrier moiety are derived, at least in part, from a murine source.
Claim 10
Dependent Claim
23 words
A support medium according to claim 5, wherein said target immunoglobulin and said carrier moiety comprise a monoclonal antibody or a fragment thereof.
Claim 11
Dependent Claim
16 words
A support medium according to claim 1, wherein said diagnostic or therapeutic substance is an immunoconjugate.
Claim 12
Dependent Claim
27 words
A support medium according to claim 10, wherein said target substance has binding characteristics similar to an effector moiety of said immunoconjugate proposed for in vivo administration.
Claim 13
Dependent Claim
17 words
A support medium according to claim 11, wherein said effector moiety of said immunoconjugate comprises a toxin.
Claim 14
Dependent Claim
45 words
A support medium according to claim 1, additionally comprising at least one control region provided on said support medium, said control region having a predetermined density of said target substance bound thereto, and additionally having a predetermined density of antibody bound to said target substance.
Claim 15
Dependent Claim
49 words
A support medium according to claim 13, comprising a high control region and a low control region provided on said support medium, said high control region having a relatively high density of antibody immobilized thereon, and said low control region having a relatively low density of antibody immobilized thereon.
Claim 16
Dependent Claim
24 words
A support medium according to claim 14, wherein said antibody bound to said target substance at said control regions comprises immune human serum immunoglobulins.
Claim 17
Dependent Claim
30 words
An assay kit comprising a support medium according to claim 1, and a vial containing an enzyme-labeled probe reagent capable of binding to antibodies that bind to said target substance.
Claim 18
Dependent Claim
19 words
An assay kit according to claim 16, wherein said enzyme-labeled probe reagent comprise HRPO-labeled F(ab') 2 mouse anti-human IgG.
Claim 19
Dependent Claim
27 words
An assay kit according to claim 16, additionally comprising a vial containing a chromogenic substrate capable of reacting with said enzyme-labeled probe reagent to provide visible color.
Claim 20
Dependent Claim
23 words
An assay kit according to claim 18, wherein said chromogenic substrate is selected from the group consisting of: ABTS; TMB; DAB; and OPD.
Claim 21
Dependent Claim
42 words
An assay kit according to claim 16, wherein said target substance is an immunoglobulin and said immunoglobulin is derived, at least in part, from a non-human source, and said enzyme-labeled probe is derived, at least in part, from the same non-human source.
Claim 22
Dependent Claim
23 words
An immunoassay kit according to claim 16, additionally comprising a color gradient chart for comparison with visible color produced in patient test regions.
Claim 23
Independent Claim
155 words
A method for detecting the presence of antibodies in a patient test specimen capable of binding to a diagnostic or therapeutic substance proposed for in vivo administration to the patient, comprising sequentially: contacting a plurality of patient specimen test regions corresponding to a plurality of densities of a target substance with the patient test specimen for an antibody binding incubation period, wherein said target substance has binding characteristics similar to binding characteristics of the diagnostic or therapeutic substance proposed for in vivo administration; removing unbound constituents of the patient test specimen from said patient specimen test regions; contacting said plurality of patient specimen test regions with a labeled probe reagent capable of binding to antibody immobilized on said plurality of patient specimen test regions for a a labeled probe binding incubation period; removing unbound constituents of said labeled probe reagent; and determining the quantity of said labeled probe at each said patient specimen test region.
Claim 24
Independent Claim
155 words
A method for detecting the presence of antibodies in a patient test specimen capable of binding to a diagnostic or therapeutic substance proposed for in vivo administration to the patient, comprising sequentially: contacting a plurality of patient specimen test regions corresponding to a plurality of densities of a target substance with the patient test specimen for an antibody binding incubation period, wherein said target substance has binding characteristics similar to binding characteristics of the diagnostic or therapeutic substance proposed for in vivo administration; removing unbound constituents of the patient test specimen from said patient specimen test regions; contacting said plurality of patient specimen test regions with a labeled probe reagent capable of binding to antibody immobilized on said plurality of patient specimen test regions for a a labeled probe binding incubation period; removing unbound constituents of said labeled probe reagent; and determining the quantity of said labeled probe at each said patient specimen test region.
Claim 25
Dependent Claim
69 words
A method according to claim 22, wherein said labeled probe comprises an enzyme-labeled probe, and said method additionally comprises contacting said plurality of patient specimen test regions with a chromogenic substrate capable of reacting with said enzyme-labeled probe, and removing constituents of said chromogenic substrate which have not reacted with said enzyme-labeled probe prior to determining the quantity of said labeled probe at each said patient specimen test region.
Claim 26
Dependent Claim
31 words
A method according to claim 22, wherein said target substance is a target immunoglobulin and has binding characteristics similar to a carrier moiety of an immunoconjugate proposed for in vivo administration.
Claim 27
Dependent Claim
17 words
A method according to claim 24, wherein said target immunoglobulin is functionally equivalent to said carrier moiety.
Claim 28
Dependent Claim
25 words
A method according to claim 25, wherein specificity determining regions of said target immunoglobulin are identical to corresponding specificity determining regions of said carrier moiety.
Claim 29
Dependent Claim
26 words
A method according to claim 24, wherein said target immunoglobulin and said carrier moiety are derived, at least in part, from the same species of origin.
Claim 30
Dependent Claim
26 words
A method according to claim 22, wherein said target substance has binding characteristics similar to an effector moiety of an immunoconjugate proposed for in vivo administration.
References Cited (Backward Citations)
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