US5137808A
Expired / Lapsed
US
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Immunoassay device
Assignee: Siemens Healthcare Diagnostics GmbH Germany
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Filing: 1989-07-31
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Granted: 1992-08-11
•
Expires: 2009-07-31
Abstract
Abstract A device is disclosed for conducting an assay method. The device comprises a housing, means enclosed in the housing for capturing a member of a specific binding pair in a zone and for allowing liquid to be transported by capillary action away from the zone, one or more self-contained liquid reagents enclosed in the housing for conducting an assay method for the determination of an analyte in the sample, and means in the housing for introducing the sample into the device. Preferably, the self-contained reagents are liquid reagents which are contained in a breakable container. The device of the invention finds use in assay methods for the determination of an analyte in a sample suspected of containing the analyte. Kits for conducting an assay method are also disclosed.
Inventors
- 👤 Edwin F. Ullman
- 👤 Pyare Khanna
- 👤 Rohan Peries
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 18:56
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; Y; Y10; Y10S; Y10S435/00; Y10S435/975; Y10S436/00; Y10S436/807; Y10S436/81
Claims Analysis
Total Claims: 74
Claim 1
Independent Claim
86 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) means enclosed in said housing for capturing a member of a specific binding pair in a zone and for allowing liquid to be transported by capillary action away from said zone, (c) one or more liquid reagents releasably contained in said housing for subsequent use in conducting an assay method for the determination of an analyte in a sample, and (d) means in said housing for introducing the sample into the device.
Claim 2
Independent Claim
86 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) means enclosed in said housing for capturing a member of a specific binding pair in a zone and for allowing liquid to be transported by capillary action away from said zone, (c) one or more liquid reagents releasably contained in said housing for subsequent use in conducting an assay method for the determination of an analyte in a sample, and (d) means in said housing for introducing the sample into the device.
Claim 3
Dependent Claim
24 words
The device of claim 1 wherein the means in (b) comprises a bibulous material that is immunosorbing or is capable of being rendered immunosorbing.
Claim 4
Dependent Claim
24 words
The device of claim 1 wherein said means in (b) comprises bibulous material having a member of a specific binding pair (sbp) bound thereto.
Claim 5
Dependent Claim
15 words
The device of claim 3 wherein said sbp member is an antibody or an antigen.
Claim 6
Dependent Claim
21 words
The device of claim 2 wherein a second piece of bibulous material is in liquid receiving relationship with said bibulous material.
Claim 7
Dependent Claim
13 words
The device of claim 5 wherein said bibulous material is a cellulose material.
Claim 8
Dependent Claim
18 words
The device of claim 1 wherein said liquid reagent or reagents are contained in a water insoluble container.
Claim 9
Dependent Claim
23 words
The device of claim 1 wherein said means in (b) is a bibulous material capable of entrapping beads coated with an sbp member.
Claim 10
Dependent Claim
15 words
The device of claim 1 wherein one or more of said liquid reagents are aqueous.
Claim 11
Dependent Claim
36 words
The device of claim 1 wherein one or more of said liquid reagents contain members of a signal producing system capable of generating a signal in relation to the amount of an analyte in the sample.
Claim 12
Dependent Claim
24 words
The device of claim 2 wherein said bibulous material has in contact with it a dry water soluble sbp member conjugated to a label.
Claim 13
Dependent Claim
25 words
The device of claim 11 wherein said label is selected from the group consisting of catalysts, enzymes, chromogens, radioactive substances, dispersible particles, and solid supports.
Claim 14
Dependent Claim
16 words
The device of claim 1 wherein said means in (d) is an opening in said device.
Claim 15
Dependent Claim
14 words
The device of claim 13 wherein said opening is adjacent to an immunosorbing zone.
Claim 16
Dependent Claim
12 words
The device of claim 2 wherein said bibulous material is a strip.
Claim 17
Dependent Claim
28 words
The device of claim 15 wherein said means for capturing a member of an sbp is a complementary sbp non-diffusively bound to said zone of said bibulous material.
Claim 18
Dependent Claim
15 words
The device of claim 1 which further comprises means for releasing said confined liquid reagent.
Claim 19
Independent Claim
94 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) bibulous material enclosed in said housing for capturing a member of a specific binding pair in a zone and for allowing liquid to be transporting by capillary action away from said zone, (c) one or more liquid reagents releasably contained in said housing for subsequently being rendered capable of traversing said bibulous material in conducting an assay method for the determination of an analyte in a sample, and (d) means in said housing for introducing the sample into the device.
Claim 20
Independent Claim
94 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) bibulous material enclosed in said housing for capturing a member of a specific binding pair in a zone and for allowing liquid to be transporting by capillary action away from said zone, (c) one or more liquid reagents releasably contained in said housing for subsequently being rendered capable of traversing said bibulous material in conducting an assay method for the determination of an analyte in a sample, and (d) means in said housing for introducing the sample into the device.
Claim 21
Dependent Claim
20 words
The device of claim 18 wherein said bibulous material has a member of a specific binding pair (sbp) bound thereto.
Claim 22
Dependent Claim
15 words
The device of claim 19 wherein said sbp member is an antibody or an antigen.
Claim 23
Dependent Claim
21 words
The device of claim 18 wherein a second piece of bibulous material is in liquid receiving relationship with said bibulous material.
Claim 24
Dependent Claim
13 words
The device of claim 18 wherein said bibulous material is a cellulose material.
Claim 25
Dependent Claim
19 words
The device of claim 18 wherein said liquid reagent or reagents are contained in a container within said housing.
Claim 26
Dependent Claim
23 words
The device of claim 18 wherein said means in (b) is a bibulous material capable of entrapping beads coated with an sbp member.
Claim 27
Dependent Claim
15 words
The device of claim 18 wherein one or more of said liquid reagents are aqueous.
Claim 28
Dependent Claim
36 words
The device of claim 18 wherein one or more of said liquid reagents contain members of a signal producing system capable of generating a signal in relation to the amount of an analyte in the sample.
Claim 29
Dependent Claim
24 words
The device of claim 18 wherein said bibulous material has in contact with it a dry water soluble sbp member conjugated to a label.
Claim 30
Dependent Claim
25 words
The device of claim 27 wherein said label is selected from the group consisting of catalysts, enzymes, chromogens, radioactive substances, dispersible particles, and solid supports.
Claim 31
Dependent Claim
16 words
The device of claim 18 wherein said means in (d) is an opening in said device.
Claim 32
Dependent Claim
14 words
The device of claim 29 wherein said opening is adjacent to an immunosorbing zone.
Claim 33
Dependent Claim
12 words
The device of claim 18 wherein said bibulous material is a strip.
Claim 34
Dependent Claim
28 words
The device of claim 19 wherein said means for capturing a member of an sbp is a complementary sbp non-diffusively bound to said zone of said bibulous material.
Claim 35
Dependent Claim
17 words
The device of claim 23 which further comprises means for releasing said liquid reagent from said container.
Claim 36
Dependent Claim
96 words
A method for conducting an assay for an analyte in a sample suspected of containing said analyte, which method comprises: (a) introducing a test solution comprising said sample into the device of claim 35 through said means of (d), (b) allowing said test solution to traverse at least a portion of said bibulous material, (c) releasing said liquid reagent to allow said liquid reagent to traverse at least a portion of said bibulous material, and (d) observing said bibulous material for the presence of a signal in relation to the presence of analyte in said sample.
Claim 37
Dependent Claim
96 words
A method for conducting an assay for an analyte in a sample suspected of containing said analyte, which method comprises: (a) introducing a test solution comprising said sample into the device of claim 1 through said means of (d), (b) allowing said test solution to traverse at least a portion of said bibulous material, (c) releasing said liquid reagent to allow said liquid reagent to traverse at least a portion of said bibulous material, and (d) observing said bibulous material for the presence of a signal in relation to the presence of analyte in said sample.
Claim 38
Independent Claim
101 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) bibulous material enclosed in said housing, said bibulous material having a component of a signal producing system bound thereto and a liquid contacting portion, said bibulous material being capable of allowing liquid to be transported by capillary action away from said liquid contacting portion, (c) one or more liquid reagents confined for subsequent release in at least one breakable container enclosed in said housing, said container being separate from or integral with said housing, and (d) means in said housing for introducing a sample into the device.
Claim 39
Independent Claim
101 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) bibulous material enclosed in said housing, said bibulous material having a component of a signal producing system bound thereto and a liquid contacting portion, said bibulous material being capable of allowing liquid to be transported by capillary action away from said liquid contacting portion, (c) one or more liquid reagents confined for subsequent release in at least one breakable container enclosed in said housing, said container being separate from or integral with said housing, and (d) means in said housing for introducing a sample into the device.
Claim 40
Dependent Claim
11 words
The device of claim 36 wherein said bibulous material is immunosorbing.
Claim 41
Dependent Claim
22 words
The device of claim 36 wherein said component of said signal producing system is a member of a specific binding pair (sbp).
Claim 42
Dependent Claim
15 words
The device of claim 38 wherein said sbp member is an antibody or an antigen.
Claim 43
Dependent Claim
21 words
The device of claim 36 wherein a second piece of bibulous material is in liquid receiving relationship with said bibulous material.
Claim 44
Dependent Claim
13 words
The device of claim 36 wherein said bibulous material is a cellulose material.
Claim 45
Dependent Claim
19 words
The device of claim 36 wherein said liquid reagent or reagents are contained in a water insoluble breakable container.
Claim 46
Dependent Claim
28 words
The device of claim 36 wherein said liquid reagent or reagents are contained in a container that is integral with said housing, said container having a breakable seal.
Claim 47
Dependent Claim
15 words
The device of claim 36 wherein one or more of said liquid reagents are aqueous.
Claim 48
Dependent Claim
37 words
The device of claim 36 wherein one or more of said liquid reagents contain other members of said signal producing system capable of generating a signal in relation to the amount of an analyte in the sample.
Claim 49
Dependent Claim
24 words
The device of claim 36 wherein said component of said signal producing system is a dry water soluble sbp member conjugated to a label.
Claim 50
Dependent Claim
25 words
The device of claim 46 wherein said label is selected from the group consisting of catalysts, enzymes, chromogens, radioactive substances, dispersible particles, and solid supports.
Claim 51
Dependent Claim
16 words
The device of claim 36 wherein said means in (d) is an opening in said device.
Claim 52
Dependent Claim
14 words
The device of claim 48 wherein said opening is adjacent to an immunosorbing zone.
Claim 53
Dependent Claim
12 words
The device of claim 36 wherein said bibulous material is a strip.
Claim 54
Dependent Claim
26 words
The device of claim 50 wherein said component of a signal producing system is an sbp member non-diffusively bound in a zone of said bibulous material.
Claim 55
Dependent Claim
15 words
The device of claim 36 which further comprises means for releasing said confined liquid reagent.
Claim 56
Independent Claim
102 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) bibulous material enclosed in said housing, said bibulous material having a component of a signal producing system bound thereto and a contact portion and being capable of allowing liquid to be transported by capillary action away from said contact portion, (c) one or more liquid reagents releasably contained in said housing for subsequently being rendered capable of traversing said bibulous material in conducting an assay method for the determination of an analyte in a sample, and (d) means in said housing for introducing the sample into the device.
Claim 57
Independent Claim
102 words
A device for conducting an assay method, said device comprising: (a) a housing, (b) bibulous material enclosed in said housing, said bibulous material having a component of a signal producing system bound thereto and a contact portion and being capable of allowing liquid to be transported by capillary action away from said contact portion, (c) one or more liquid reagents releasably contained in said housing for subsequently being rendered capable of traversing said bibulous material in conducting an assay method for the determination of an analyte in a sample, and (d) means in said housing for introducing the sample into the device.
Claim 58
Dependent Claim
22 words
The device of claim 53 wherein said component of said signal producing system is a member of a specific binding pair (sbp).
Claim 59
Dependent Claim
15 words
The device of claim 54 wherein said sbp member is an antibody or an antigen.
Claim 60
Dependent Claim
21 words
The device of claim 53 wherein a second piece of bibulous material is in liquid receiving relationship with said bibulous material.
Claim 61
Dependent Claim
13 words
The device of claim 53 wherein said bibulous material is a cellulose material.
Claim 62
Dependent Claim
20 words
The device of claim 53 wherein said liquid reagent or reagents are contained in a breakable container within said housing.
Claim 63
Dependent Claim
28 words
The device of claim 53 wherein said liquid reagent or reagents are contained in a container that is integral with said housing, said container having a breakable seal.
Claim 64
Dependent Claim
15 words
The device of claim 53 wherein one or more of said liquid reagents are aqueous.
Claim 65
Dependent Claim
37 words
The device of claim 53 wherein one or more of said liquid reagents contain other members of said signal producing system capable of generating a signal in relation to the amount of an analyte in the sample.
Claim 66
Dependent Claim
24 words
The device of claim 53 wherein said component of said signal producing system is a dry water soluble sbp member conjugated to a label.
Claim 67
Dependent Claim
25 words
The device of claim 62 wherein said label is selected from the group consisting of catalysts, enzymes, chromogens, radioactive substances, dispersible particles, and solid supports.
Claim 68
Dependent Claim
16 words
The device of claim 53 wherein said means in (d) is an opening in said device.
Claim 69
Dependent Claim
14 words
The device of claim 64 wherein said opening is adjacent to an immunosorbing zone.
Claim 70
Dependent Claim
12 words
The device of claim 53 wherein said bibulous material is a strip.
Claim 71
Dependent Claim
26 words
The device of claim 64 wherein said component of said signal producing system is an sbp member non-diffusively bound in a zone on said bibulous material.
Claim 72
Dependent Claim
17 words
The device of claim 58 which further comprises means for releasing said liquid reagent from said container.
Claim 73
Dependent Claim
96 words
A method for conducting an assay for an analyte in a sample suspected of containing said analyte, which method comprises: (a) introducing a test solution comprising said analyte into the device of claim 36 through said means of (d) (b) allowing said test solution to traverse at least a portion of said bibulous material, (c) breaking said breakable container to allow said liquid reagent to traverse at least a portion of said bibulous material, and (d) observing said bibulous material for the presence of a signal in relation to the presence of analyte in said sample.
Claim 74
Dependent Claim
96 words
A method for conducting an assay for an analyte in a sample suspected of containing said analyte, which method comprises: (a) introducing a test solution comprising said analyte into the device of claim 53 through said means of (d), (b) allowing said test solution to traverse at least a portion of said bibulous material, (c) releasing said liquid reagent to allow said liquid reagent to traverse at least a portion of said bibulous material, and (d) observing said bibulous material for the presence of a signal in relation to the presence of analyte in said sample.
References Cited (Backward Citations)
US4918025A
Cited
US4857453A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1995-08-11 | 1996-02-10 | 1996-08-11 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-08-11 | 2000-02-10 | 2000-08-11 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-08-11 | 2004-02-10 | 2004-08-11 | $7700.00 | Window Closed / Lapsed |