US4843000A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Simultaneous calibration heterogeneous immunoassay
Assignee: Siemens Healthcare Diagnostics GmbH Germany
•
Filing: 1985-05-21
•
Granted: 1989-06-27
•
Expires: 2005-05-21
Abstract
Abstract An assay method and compositions are provided for determining the presence of an analyte in a sample. The analyte is a member of an immunological pair (mip) comprising ligand and receptor. By providing a first measurement surface capable of specifically binding a labelled reagent in an amount depending upon the presence of analyte in the sample and a second calibration surface capable of binding a second labeled reagent in a manner unaffected by the presence of analyte in the sample, calibration of individual tests can be accomplished simulataneously with the performance of the test itself. A signal producing system includes an enzyme bonded to a mip which defines the first labeled reagent for binding to the measurement surface and the same enzyme conjugated to a ligand capable of binding to the calibration surface. Preferably, both labeled reagents have the same composition and the calibration surface includes anti-(first enzyme).
Inventors
- 👤 David J. Litman
- 👤 Edwin F. Ullman
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 17:46
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/58; G01N33/581; G01N33/52; G01N33/53; G01N33/536; G01N33/542; G01N33/543; G01N33/54306; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S436/00; Y10S436/807; Y10S436/81
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
184 words
In a method for determining the presence in a sample of an analyte, which analyte is a member of a specific binding pair ("mip") consisting of ligand and receptor ("antiligand"), said method employing at least one catalyst including a catalyst bound to a mip ("catalyst-bound-mip") and a solute which is catalytically transformed by a catalyst bound to a mip-containing measurement first surface to produce a detectable signal at said first surface in proportion to the amount of catalyst-bound-mip bound to said first surface, wherein contacting of said first surface with said sample and said catalyst-bound-mip results in binding of said catalyst-bound-mip to said first surface in proportion to the amount of analyte in said sample, the improvement which comprises: having adjacent to said first surface a calibration second surface to which said catalyst is directly bound in an amount to produce a signal level at said second surface corresponding to a predetermined amount of analyte and said analyte in said sample is determined by comparing the intensity of the signal at said first surface to the intensity of the signal at said second surface.
Claim 2
Dependent Claim
184 words
In a method for determining the presence in a sample of an analyte, which analyte is a member of a specific binding pair ("mip") consisting of ligand and receptor ("antiligand"), said method employing at least one catalyst including a catalyst bound to a mip ("catalyst-bound-mip") and a solute which is catalytically transformed by a catalyst bound to a mip-containing measurement first surface to produce a detectable signal at said first surface in proportion to the amount of catalyst-bound-mip bound to said first surface, wherein contacting of said first surface with said sample and said catalyst-bound-mip results in binding of said catalyst-bound-mip to said first surface in proportion to the amount of analyte in said sample, the improvement which comprises: having adjacent to said first surface a calibration second surface to which said catalyst is directly bound in an amount to produce a signal level at said second surface corresponding to a predetermined amount of analyte and said analyte in said sample is determined by comparing the intensity of the signal at said first surface to the intensity of the signal at said second surface.
Claim 3
Dependent Claim
12 words
A method according to claim 1, wherein said catalyst is an enzyme.
Claim 4
Dependent Claim
228 words
In a method for determining the presence in a sample of an analyte, which analyte is a member of a specific binding pair ("mip") consisting of ligand and receptor ("antiligand"), said method employing at least one catalyst including catalyst bound to a mip ("catalyst-bound-mip") and a solute which is catalytically transformed by a catalyst bound to a mip-containing measurement first surface to produce a detectable signal at said first surface in proportion to the amount of catalyst-bound-mip bound to said first surface, wherein contacting of said first surface with said sample and said catalyst-bound-mip results in binding of said catalyst-bound-mip to said first surface in proportion to the amount of analyte in said sample, the improvement which comprises: having adjacent to said first surface a calibration second surface to which said first catalyst binds by means of mip complex formation in an amount to produce a signal level at said second surface corresponding to a pre-determined amount of analyte, wherein the binding of said catalyst to said calibration second surface involves a determinant site on said catalyst or a determinant site on the catalyst-bound-mip other than the determinant site involved in the binding of said catalyst-bound-mip to said measurement first surface, whereby said analyte in said sample is determined by comparing the intensity of signal at said second surface to the intensity of signal at said first surface.
Claim 5
Dependent Claim
228 words
In a method for determining the presence in a sample of an analyte, which analyte is a member of a specific binding pair ("mip") consisting of ligand and receptor ("antiligand"), said method employing at least one catalyst including catalyst bound to a mip ("catalyst-bound-mip") and a solute which is catalytically transformed by a catalyst bound to a mip-containing measurement first surface to produce a detectable signal at said first surface in proportion to the amount of catalyst-bound-mip bound to said first surface, wherein contacting of said first surface with said sample and said catalyst-bound-mip results in binding of said catalyst-bound-mip to said first surface in proportion to the amount of analyte in said sample, the improvement which comprises: having adjacent to said first surface a calibration second surface to which said first catalyst binds by means of mip complex formation in an amount to produce a signal level at said second surface corresponding to a pre-determined amount of analyte, wherein the binding of said catalyst to said calibration second surface involves a determinant site on said catalyst or a determinant site on the catalyst-bound-mip other than the determinant site involved in the binding of said catalyst-bound-mip to said measurement first surface, whereby said analyte in said sample is determined by comparing the intensity of signal at said second surface to the intensity of signal at said first surface.
Claim 6
Independent Claim
53 words
A method according to any of claims 1, 2, or 3, wherein said signal producing system includes two enzymes as catalysts, wherein the product of one enzyme is the substrate of the other enzyme, and one of the enzymes is bound to each of said first and second surfaces prior to said contacting.
Claim 7
Dependent Claim
29 words
A method according to claim 4, wherein said solute is a dye precursor which undergoes an enzyme catalyzed reaction to produce an insoluable dye which binds to said surface.
Claim 8
Dependent Claim
11 words
A method according to claim 5, wherein said catalyst-bound-mip is enzyme-bound-antiligand.
Claim 9
Dependent Claim
11 words
A method according to claim 5, wherein said catalyst-bound-mip is enzyme-bound-ligand.
Claim 10
Dependent Claim
259 words
In a method for determining the presence in a sample of an analyte, which analyte is a member of a specific binding pair ("mip") consisting of ligand and receptor "antiligand") said method employing a signal producing system having at least two enzymes, including one enzyme bound to a mip ("enzyme-bound-mip"), and a solute dye precursor which is catalytically transformed to an insoluable dye by one of said enzymes bound to a mip-containing measurement first surface, said insoluble dye producing a detectable signal at said first surface in proportion to the amount of analyte, where said mip at said first surface provides for binding of enzyme-bound-mip through mip complex formation to said first surface, wherein contacting of said first surface with said sample and said enzyme-bound-mip results in binding of said enzyme-bound-mip to said surface in proportion to the amount of analyte in said sample, the improvement which comprises: during said contacting, having adjacent to said first surface a calibration second surface to which enzyme of said enzyme-bound-mip becomes bound through mip complex formation in an amount to produce a signal level at said second surface corresponding to a pre-determined amount of analyte, wherein the mip complex formation on said calibration second surface involves a determinant site on said enzyme or a dterminant site on the enzyme-bound-mip other than the determinant site involved in the mip complex formation on said measurement first surface, whereby said analyte in said sample is determined by comparing the intensity of signal at said second surface to the intensity of signal at said first surface.
Claim 11
Dependent Claim
259 words
In a method for determining the presence in a sample of an analyte, which analyte is a member of a specific binding pair ("mip") consisting of ligand and receptor "antiligand") said method employing a signal producing system having at least two enzymes, including one enzyme bound to a mip ("enzyme-bound-mip"), and a solute dye precursor which is catalytically transformed to an insoluable dye by one of said enzymes bound to a mip-containing measurement first surface, said insoluble dye producing a detectable signal at said first surface in proportion to the amount of analyte, where said mip at said first surface provides for binding of enzyme-bound-mip through mip complex formation to said first surface, wherein contacting of said first surface with said sample and said enzyme-bound-mip results in binding of said enzyme-bound-mip to said surface in proportion to the amount of analyte in said sample, the improvement which comprises: during said contacting, having adjacent to said first surface a calibration second surface to which enzyme of said enzyme-bound-mip becomes bound through mip complex formation in an amount to produce a signal level at said second surface corresponding to a pre-determined amount of analyte, wherein the mip complex formation on said calibration second surface involves a determinant site on said enzyme or a dterminant site on the enzyme-bound-mip other than the determinant site involved in the mip complex formation on said measurement first surface, whereby said analyte in said sample is determined by comparing the intensity of signal at said second surface to the intensity of signal at said first surface.
References Cited (Backward Citations)
US4315907A
Cited
US4299916A
Cited
US4391904A
Cited
US4366241A
Cited
US4366241B1
Cited
US4533629A
Cited
US4540659A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-06-26 | 1992-12-26 | 1993-06-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-06-26 | 1996-12-26 | 1997-06-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-06-26 | 2000-12-26 | 2001-06-27 | $7700.00 | Window Closed / Lapsed |