US4461829A
Expired / Lapsed
US
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Homogeneous specific binding assay element and lyophilization production method
Assignee: Bayer Corp
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Filing: 1981-09-14
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Granted: 1984-07-24
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Expires: 2001-09-14
Abstract
Abstract A homogeneous specific binding assay element, a method for its preparation, and a method for its use in determining a ligand in or the ligand binding capacity of a liquid sample are disclosed. The test element comprises a solid carrier incorporated with reagents for a homogeneous specific binding assay system which produces a detectable response, usually an electromagnetic radiation signal, that is a function of the presence or amount of the ligand in or the ligand binding capacity of the sample. There is further disclosed a method for preparing a homogeneous specific binding assay element for determining a ligand in or the ligand binding capacity of a liquid sample by incorporating a carrier with a composition which includes a label conjugate, comprising a label component coupled to a ligand moiety or a specific binding analog thereof, and a reagent reactive with the label conjugate, which method comprises (a) incorporating the carrier with the reagent reactive with the label conjugate in a first liquid; (b) subjecting the carrier of (a) to conditions effective to reversibly suspend or reduce the activity of the reagent therein; (c) incorporating the carrier of (b) with the label conjugate; (d) subjecting the carrier of (c) to a temperature effective to freeze the reagent reactive with the label conjugate and the label conjugate; and (e) lyophilizing the reagent and label conjugate in the carrier of (d).
Inventors
- 👤 Alfred C. Greenquist
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 17:45
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/58; G01N33/582; G01N33/53; G01N33/536; G01N33/542; G01N33/543; G01N33/54366; G01N33/54386; G01N33/581; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/97; Y10S436/00; Y10S436/807; Y10S436/81
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
120 words
A test device for determining a ligand in, or the ligand binding capacity of, a test sample, the device comprising a support member having a substantially planar side, a carrier member affixed to the substantially planar side, the carrier member comprising a substantially bibulous material, and a reagent system homogeneously incorporated with, but not bound to, the carrier member, the reagent system comprising ingredients capable of participating in a specific binding assay and including a label conjugate and a specific binding partner to the conjugate and the ligand, the conjugate comprising a label bound to the ligand or a specific binding analogue thereof, the conjugate and specific binding partner therefor being present in the carrier substantially unbound to one another.
Claim 2
Dependent Claim
120 words
A test device for determining a ligand in, or the ligand binding capacity of, a test sample, the device comprising a support member having a substantially planar side, a carrier member affixed to the substantially planar side, the carrier member comprising a substantially bibulous material, and a reagent system homogeneously incorporated with, but not bound to, the carrier member, the reagent system comprising ingredients capable of participating in a specific binding assay and including a label conjugate and a specific binding partner to the conjugate and the ligand, the conjugate comprising a label bound to the ligand or a specific binding analogue thereof, the conjugate and specific binding partner therefor being present in the carrier substantially unbound to one another.
Claim 3
Dependent Claim
23 words
The test device of claim 1 in which the label conjugate is a fluor bound to the ligand or specific binding analogue thereof.
Claim 4
Dependent Claim
13 words
The test device of claim 1 in which the label conjugate is unbelliferone-ligand.
Claim 5
Dependent Claim
23 words
The test device of claim 1 in which the reagent system additionally includes a component capable of cleaving the label from the conjugate.
Claim 6
Dependent Claim
24 words
The test device of claim 4 in which the label is an enzyme substrate and the compound is an enzyme reactive with the substrate.
Claim 7
Dependent Claim
19 words
The test device of claim 5 in which the label is a β-galactoside moiety and the enzyme is β-galactosidase.
Claim 8
Dependent Claim
18 words
The test device of claim 6 in which the label conjugate is β-galactosyl-umbelliferone-ligand or specific binding analogue thereof.
Claim 9
Independent Claim
182 words
A method for preparing a test device for determining a ligand in, or the ligand binding capacity of, a test sample, the method comprising the sequential steps of incorporating a carrier member with a reagent system in a first solvent, the reagent system being capable of producing a detectable response to the presence of a label conjugate, and including a specific binding partner to the conjugate and a component capable of cleaving the label from the conjugate to produce a detectable response, drying the carrier member, to remove the first solvent cooling the dried carrier member to a temperature sufficient to substantially prevent the component from cleaving the label, further incorporating the carrier member with the label conjugate in a second solvent, the conjugate comprising the label coupled to the ligand or specific binding analogue thereof, the label being a moiety cleavable by the component to produce a detectable response, cooling the carrier member to a temperature sufficient to freeze the second solvent at a rate sufficient to prevent substantial cleavage of the label by the component, and lyophilizing the carrier member.
Claim 10
Independent Claim
182 words
A method for preparing a test device for determining a ligand in, or the ligand binding capacity of, a test sample, the method comprising the sequential steps of incorporating a carrier member with a reagent system in a first solvent, the reagent system being capable of producing a detectable response to the presence of a label conjugate, and including a specific binding partner to the conjugate and a component capable of cleaving the label from the conjugate to produce a detectable response, drying the carrier member, to remove the first solvent cooling the dried carrier member to a temperature sufficient to substantially prevent the component from cleaving the label, further incorporating the carrier member with the label conjugate in a second solvent, the conjugate comprising the label coupled to the ligand or specific binding analogue thereof, the label being a moiety cleavable by the component to produce a detectable response, cooling the carrier member to a temperature sufficient to freeze the second solvent at a rate sufficient to prevent substantial cleavage of the label by the component, and lyophilizing the carrier member.
Claim 11
Dependent Claim
28 words
The method of claim 8 in which the label is a substrate for an enzyme, and the component is the enzyme for which the label is a substrate.
Claim 12
Dependent Claim
29 words
The method of claim 8 in which the ligand is theophylline, the label conjugate is theophylline-umbelliferone-galactose, the component is β-galactosidase and the specific binding partner is antibody to theophylline.
Claim 13
Dependent Claim
18 words
The method of claim 8 in which the label is a β-galactoside moiety and the component is β-galactosidase.
Claim 14
Dependent Claim
16 words
The method of claim 11 in which the label conjugate is β-galactosyl-umbelliferone-ligand or ligand binding analogue.
References Cited (Backward Citations)
US3905767A
Cited
US4017597A
Cited
US4230797A
Cited
US4059407A
Cited
US4094647A
Cited
US4279992A
Cited
US4260392A
Cited
US4258001A
Cited
US4299916A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1987-07-24 | 1988-01-23 | 1988-07-24 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-07-24 | 1992-01-23 | 1992-07-24 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-07-24 | 1996-01-23 | 1996-07-24 | $7700.00 | Window Closed / Lapsed |