US4459360A
Expired / Lapsed
US
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Multiple-component binding assay system and method of making and using it
Assignee: Hitachi Chemical Diagnostics Inc
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Filing: 1981-10-05
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Granted: 1984-07-10
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Expires: 2001-10-05
Abstract
Abstract A multiple component binding assay system, and related methods of making and using it, having a plurality of coated filaments mounted at their opposite ends on a support, in a predetermined spaced relationship, for simultaneously screening a liquid test sample for a plurality of components. The system is particularly suitable for screening the sample for IgE class antibodies specific for certain allergens. The filaments are preferably cotton threads, each thread binding a different allergen through a covalent bond. The support, which is preferably cut away adjacent the mid-portion of each filament to reduce background interference, is composed of a plastic or other water insoluble material, permitting inexpensive and relatively simple manufacture. After any IgE class antibodies present in the liquid sample have reacted with the corresponding allergens coated on the filaments, they are detected using second antibodies labeled with radioactive, fluorescent or enzymatic tracers. By using a high energy radioactive tracer, such as 125I, autoradiographic techniques with phosphor screen enhancement allow for diagnostic analysis by a densitometer or even the unaided human eye.
Inventors
- 👤 Vincent A. Marinkovich
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 13:31
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/521; G01N33/53; G01N33/543; G01N33/544; G01N33/548; Y; Y10; Y10S; Y10S436/00; Y10S436/804; Y10S436/807; Y10S436/808; Y10S436/81
Claims Analysis
Total Claims: 64
Claim 1
Independent Claim
55 words
For use in the diagnostic analysis of a liquid specimen through binding assays, a diagnostic system comprising a plurality of filaments supported in a spaced relationship for simultaneous contact with said liquid specimen, at least two of said filaments being coated with binding assay components from different assays, for multiple, coincident measurement of said assays.
Claim 2
Dependent Claim
55 words
For use in the diagnostic analysis of a liquid specimen through binding assays, a diagnostic system comprising a plurality of filaments supported in a spaced relationship for simultaneous contact with said liquid specimen, at least two of said filaments being coated with binding assay components from different assays, for multiple, coincident measurement of said assays.
Claim 3
Dependent Claim
14 words
The diagnostic system of claim 1 wherein said binding assay component is an antigen.
Claim 4
Dependent Claim
14 words
The diagnostic system of claim 1 wherein said binding assay component is an allergen.
Claim 5
Dependent Claim
13 words
The diagnostic system of claim 1 wherein said filaments consist essentially of cotton.
Claim 6
Dependent Claim
11 words
The diagnostic system of claim 1 wherein said filaments are threads.
Claim 7
Dependent Claim
59 words
A diagnostic test kit useful in screening for the presence of multiple allergen-specific IgE class antibodies in a liquid test sample, said kit comprising a plurality of threads supported in a predetermined spaced relationship for simultaneous contact with said test sample, wherein at least two of said threads are coated with allergen compositions specific to different IgE class antibodies.
Claim 8
Dependent Claim
59 words
A diagnostic test kit useful in screening for the presence of multiple allergen-specific IgE class antibodies in a liquid test sample, said kit comprising a plurality of threads supported in a predetermined spaced relationship for simultaneous contact with said test sample, wherein at least two of said threads are coated with allergen compositions specific to different IgE class antibodies.
Claim 9
Dependent Claim
10 words
The kit of claim 6 wherein the threads are cotton.
Claim 10
Dependent Claim
13 words
The kit of claim 6 wherein the threads consist essentially of a polysaccharide.
Claim 11
Dependent Claim
18 words
The kit of claim 6 wherein each allergen composition is bound to a thread through a covalent bond.
Claim 12
Dependent Claim
15 words
The kit of claim 9 wherein said covalent bond is formed with a cyanogen halide.
Claim 13
Dependent Claim
25 words
The kit of claim 6 further comprising labeled antibodies reactive with said IgE for detection and measurement of IgE class antibodies bound to said thread.
Claim 14
Dependent Claim
20 words
The kit of claim 11 wherein the antibodies reactive with said IgE class antibodies are labeled with a radioactive tracer.
Claim 15
Dependent Claim
12 words
The kit of claim 12 wherein said radioactive tracer is 125 I.
Claim 16
Dependent Claim
20 words
The kit of claim 11 wherein the antibodies reactive with said IgE class antibodies are labelled with a fluorescent tracer.
Claim 17
Dependent Claim
19 words
The kit of claim 11 wherein the antibodies reactive with said IgE class antibodies are labelled with an enzyme.
Claim 18
Dependent Claim
22 words
The kit of claim 11 wherein the antibodies reactive with said IgE class antibodies are labeled with an enzyme substrate or coenzyme.
Claim 19
Independent Claim
76 words
A method of detecting the presence of biological agents in a liquid specimen through binding assays, said method comprising the steps of: incubating said liquid specimen with a plurality of filaments supported in a predetermined spaced relationship, at least two of said filaments being coated with binding assay components from different assays; and analyzing said filaments to coincidently determine which of the biological agents, interact with said binding assay component coated on each of said filaments.
Claim 20
Independent Claim
76 words
A method of detecting the presence of biological agents in a liquid specimen through binding assays, said method comprising the steps of: incubating said liquid specimen with a plurality of filaments supported in a predetermined spaced relationship, at least two of said filaments being coated with binding assay components from different assays; and analyzing said filaments to coincidently determine which of the biological agents, interact with said binding assay component coated on each of said filaments.
Claim 21
Dependent Claim
11 words
The method of claim 17 wherein said binding assays are immunoassays.
Claim 22
Dependent Claim
12 words
The method of claim 17 wherein said binding assay components are allergens.
Claim 23
Dependent Claim
12 words
The method of claim 17 wherein said filaments are analyzed by autoradiography.
Claim 24
Independent Claim
106 words
A method of screening for the presence of multiple allergen-specific IgE class antibodies in a liquid test sample, said method comprising the steps of: incubating said test sample with a plurality of filaments supported on a support in a predetermined spaced relationship and coated with allergens specific to said IgE class antibodies; removing said filaments from said test sample; incubating said filaments with a solution containing labeled antibodies that are reactive with said IgE class antibodies; removing said filaments from said solution; and analyzing said filaments to determine the presence of said labeled antibodies; wherein at least two of said filaments are coated with different allergens.
Claim 25
Independent Claim
106 words
A method of screening for the presence of multiple allergen-specific IgE class antibodies in a liquid test sample, said method comprising the steps of: incubating said test sample with a plurality of filaments supported on a support in a predetermined spaced relationship and coated with allergens specific to said IgE class antibodies; removing said filaments from said test sample; incubating said filaments with a solution containing labeled antibodies that are reactive with said IgE class antibodies; removing said filaments from said solution; and analyzing said filaments to determine the presence of said labeled antibodies; wherein at least two of said filaments are coated with different allergens.
Claim 26
Dependent Claim
11 words
The method of claim 21 wherein the labeled antibodies are radioactive.
Claim 27
Dependent Claim
12 words
The method of claim 22 wherein the radioactive antibodies contain 125 I.
Claim 28
Dependent Claim
14 words
The method of claim 22 wherein the analysis is accomplished with a gamma counter.
Claim 29
Dependent Claim
35 words
The method of claim 22 wherein the analysis of the filament for the presence of labeled antibodies is accomplished by placing the filaments proximate to a film for exposing said film by said labeled antibodies.
Claim 30
Dependent Claim
23 words
The method of claim 25 wherein one or more phosphor screens are placed adjacent said film and said filaments to increase film exposure.
Claim 31
Dependent Claim
15 words
The method of claim 25 wherein the film is read by the unaided human eye.
Claim 32
Dependent Claim
13 words
The method of claim 25 wherein the film is read by a densitometer.
Claim 33
Dependent Claim
12 words
The method of claim 28 wherein the densitometer is a scanning densitometer.
Claim 34
Dependent Claim
11 words
The method of claim 21 wherein the labeled antibodies are fluorescent.
Claim 35
Dependent Claim
22 words
The method of claim 30 wherein the analysis of the filaments for the presence of labeled antibodies is accomplished with a fluorometer.
Claim 36
Dependent Claim
18 words
The method of claim 21 wherein the labelled antibodies are labeled with an enzyme, enzyme substrate or coenzyme.
Claim 37
Dependent Claim
13 words
The method of claim 21 wherein the analysis is accomplished with a spectrophotometer.
Claim 38
Dependent Claim
18 words
The method of claim 21 wherein a portion of the support is cut away to minimize background interference.
Claim 39
Dependent Claim
16 words
The method of claim 21 wherein the plurality of filaments comprises at least about eight filaments.
Claim 40
Independent Claim
52 words
A method of making an apparatus useful in the diagnostic analysis of liquid specimens through binding assays, said method comprising the steps of: coating each of a plurality of filaments with components of different binding assays; and attaching the coated filaments to a support such that they are arranged in spaced relationship.
Claim 41
Independent Claim
52 words
A method of making an apparatus useful in the diagnostic analysis of liquid specimens through binding assays, said method comprising the steps of: coating each of a plurality of filaments with components of different binding assays; and attaching the coated filaments to a support such that they are arranged in spaced relationship.
Claim 42
Dependent Claim
12 words
The method of claim 36 wherein said binding assay is an immunoassay.
Claim 43
Dependent Claim
13 words
The method of claim 36 wherein said binding assay component is an antigen.
Claim 44
Dependent Claim
13 words
The method of claim 36 wherein said binding assay component is an allergen.
Claim 45
Dependent Claim
14 words
The method of claim 36 wherein said support consists essentially of water insoluble material.
Claim 46
Dependent Claim
25 words
The method of claim 36 further comprising the step of cutting the support and attached filaments into a plurality of elongated strips of predetermined size.
Claim 47
Dependent Claim
16 words
The method of claim 36 wherein said binding assay component is covalently bound to said filament.
Claim 48
Dependent Claim
12 words
The method of claim 36 wherein said filament is a cotton thread.
Claim 49
Independent Claim
77 words
A method of making a miniature apparatus for use in the simultaneous determination of the presence of multiple allergen-specific IgE class antibodies in a liquid test sample, said method comprising the steps of: coating a filament with an allergen composition specific to at least one of said IgE class antibodies; and attaching a plurality of said filaments to a support; wherein at least two of said filaments attached to said support are coated with different allergen compositions.
Claim 50
Independent Claim
77 words
A method of making a miniature apparatus for use in the simultaneous determination of the presence of multiple allergen-specific IgE class antibodies in a liquid test sample, said method comprising the steps of: coating a filament with an allergen composition specific to at least one of said IgE class antibodies; and attaching a plurality of said filaments to a support; wherein at least two of said filaments attached to said support are coated with different allergen compositions.
Claim 51
Dependent Claim
25 words
The method of claim 44 further comprising the step of cutting said support and attached filaments into a plurality of elongated strips of predetermined size.
Claim 52
Dependent Claim
17 words
The method of claim 44 wherein one of said allergen composition comprises a mixture of related allergens.
Claim 53
Dependent Claim
27 words
The method of claim 46 wherein said mixture is a grass mix, mugwort mix, olive mix, ragweed mix, walnut mix, alternaria mix, dematiaceae mix or penicillium mix.
Claim 54
Dependent Claim
15 words
The method of claim 44 wherein said allergen composition is a defatted and extracted allergen.
Claim 55
Dependent Claim
15 words
The method of claim 48 wherein said allergen composition is covalently bound to said filament.
Claim 56
Dependent Claim
12 words
The method of claim 49 wherein said filament is a cotton thread.
Claim 57
Dependent Claim
14 words
The method of claim 50 wherein said covalent bond is formed with cyanogen bromide.
Claim 58
Dependent Claim
42 words
The diagnostic system of claim 1 wherein: the system further includes an elongated, flat support on which the plurality of filaments are supported; and the filaments are oriented substantially parallel to each other and perpendicular to the longitudinal axis of the support.
Claim 59
Dependent Claim
17 words
The diagnostic system of claim 52 wherein the support contacts the filaments only at their respective ends.
Claim 60
Independent Claim
147 words
A method of detecting the presence of multiple biological agents in a liquid specimen through binding assays, comprising steps of: incubating the liquid specimen with a diagnostic device having a plurality of filaments secured to a support member, at least two of the filaments being coated with binding assay components that react with different biological agents that might be present in the specimen; separating the liquid specimen and the diagnostic device from each other; incubating the diagnostic device with a solution containing labeled components that will bind to any of the biological agents that might have bound to the binding assay components in the first step of incubating; separating the diagnostic device and the solution from each other; and positioning the diagnostic device proximate to a photographic film, to expose a pattern in the film indicative of the presence of labeled components on each of the filaments.
Claim 61
Independent Claim
147 words
A method of detecting the presence of multiple biological agents in a liquid specimen through binding assays, comprising steps of: incubating the liquid specimen with a diagnostic device having a plurality of filaments secured to a support member, at least two of the filaments being coated with binding assay components that react with different biological agents that might be present in the specimen; separating the liquid specimen and the diagnostic device from each other; incubating the diagnostic device with a solution containing labeled components that will bind to any of the biological agents that might have bound to the binding assay components in the first step of incubating; separating the diagnostic device and the solution from each other; and positioning the diagnostic device proximate to a photographic film, to expose a pattern in the film indicative of the presence of labeled components on each of the filaments.
Claim 62
Dependent Claim
48 words
The method of claim 54 wherein: the labeled components present in the solution used in the second step of incubating are labeled with a radioactive tracer; and the method further includes a step of positioning a phosphor screen adjacent to the photographic film, to enhance the film exposure.
Claim 63
Dependent Claim
81 words
The method of claim 54 wherein: the filaments are secured at least at their opposite ends to the support member in a substantially parallel and spaced apart relationship such that the step of positioning results in a pattern of spaced lines being exposed in the film, each such line having an exposure indicative of the concentration of labeled components on the corresponding filament; and the method further includes a step of measuring the exposure of the spaced lines in the film.
Claim 64
Dependent Claim
46 words
The method of claim 54 wherein: the biological agents detected by the method are allergen-specific IgE class antibodies; the binding assay components coated on the filaments are allergens; and the labeled components contained in the solution used in the second step of incubating are anti-IgE antibodies.
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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) | 1987-07-10 | 1988-01-09 | 1988-07-10 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-07-10 | 1992-01-09 | 1992-07-10 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-07-10 | 1996-01-09 | 1996-07-10 | $7700.00 | Window Closed / Lapsed |