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EP0196845A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Processes for the stabilization of prostate specific antigen in natural matrices

Assignee: Hybritech Inc
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Filing: 1986-03-21
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Granted: —
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Expires: 2006-03-21
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Abstract

Abstract Processes for preparing stable natural matrices for prostrate specific antigen (PSA) are disclosed. Biological carrier fluids for PSA obtained from a suitable mammal are modified to inhibit the activity of components of the biological fluids destabilizing to PSA. The stable natural matrices, prepared in accordance with the present invention. are useful in the measurement of PSA in a sample by means of an immunoassay.

Inventors

  • 👤 Tina Susan Berger
  • 👤 Linda Patricia Ivor

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-07 16:10
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/575; G01N33/57525

Claims Analysis

Total Claims: 26
Claim 1
Independent Claim 54 words
A process for preparing a stable natural matrix for use in the measurement of prostate specific antigen (PSA) in a fluid sample by means of an immunoassay comprising modifying a biological carrier fluid for PSA obtained from a suitable mammal to inhibit the activity of components of said biologic fluid destabilizing to said PSA.
Claim 2
Dependent Claim 54 words
A process for preparing a stable natural matrix for use in the measurement of prostate specific antigen (PSA) in a fluid sample by means of an immunoassay comprising modifying a biological carrier fluid for PSA obtained from a suitable mammal to inhibit the activity of components of said biologic fluid destabilizing to said PSA.
Claim 3
Dependent Claim 15 words
The process according to claim 1 wherein said biologic fluid comprises blood, serum or plasma.
Claim 4
Dependent Claim 15 words
The process according to claims 1 or claim 2 wherein said mammal is a human.
Claim 5
Dependent Claim 12 words
The process according to claim 3 wherein said mammal is a female.
Claim 6
Dependent Claim 19 words
The process according to claim 1 or claim 2 wherein said natural matrix is used as a calibrator matrix.
Claim 7
Dependent Claim 18 words
The process according to claim 1 or claim 2 wherein said natural matrix is used as a diluent.
Claim 8
Dependent Claim 18 words
The process according to claim 1 or claim 2 wherein said immunoassay is a monoclonal antibody-based immunometric assay.
Claim 9
Dependent Claim 14 words
The process according to claim 7 wherein said immunoassay is a "two-site" immunometric assay.
Claim 10
Dependent Claim 28 words
The process according to claim 7 wherein the said immunometric assay is accomplished by means selected from the group consisting of radiometric means, enzymatic means and fluorometric means.
Claim 11
Dependent Claim 42 words
The process according to claim 1 or claim 2 wherein said modifying step comprises adjusting the pH of said biological fluid to a pH, and for a period of time, effective to inhibit the destabilizing activity of components of said biological fluid.
Claim 12
Dependent Claim 55 words
The process according to claim 10 wherein said modifying step further comprises increasing the pH of said biological fluid to at least about pH 9 for a period of time effective to inhibit the activity of the components of said biological fluid and thereafter decreasing the pH of said biological fluid to about pH 7.
Claim 13
Dependent Claim 18 words
The process according-to claim 11 wherein the pH of said biological fluid is increased to about pH 12.
Claim 14
Dependent Claim 38 words
The process according to claim 1 or claim 2 wherein said modifying step comprises treating said biological fluid with a chaotropic agent for a time sufficient to inhibit the destabilizing activity of the components of the biological fluid.
Claim 15
Dependent Claim 49 words
A process for stabilizing prostate specific antigen (PSA) in a serum-based matrix for use in the measurement of said PSA in a fluid sample by means of an immunoassay comprising modifying serum obtained from a suitable human female to inhibit the activity of serum components destabilizing to said PSA.
Claim 16
Dependent Claim 49 words
A process for stabilizing prostate specific antigen (PSA) in a serum-based matrix for use in the measurement of said PSA in a fluid sample by means of an immunoassay comprising modifying serum obtained from a suitable human female to inhibit the activity of serum components destabilizing to said PSA.
Claim 17
Dependent Claim 16 words
The process according to claim 14 wherein said serum-based matrix is used as a calibrator matrix.
Claim 18
Dependent Claim 16 words
The process according to claim 14 wherein said serum-based matrix composition is used as a diluent.
Claim 19
Dependent Claim 32 words
The process according to claim 14 wherein said modifying step further comprises shifting the pH of said serum for a period of time effective to inhibit the activity of said serum components.
Claim 20
Dependent Claim 50 words
The process according to claim 17 wherein said modifying step further comprises increasing the pH of said serum to at least about pH 9 for a period of time effective to inhibit the activity of said serum components and thereafter decreasing the pH of said serum to about pH 7.
Claim 21
Dependent Claim 18 words
The process according to claim 18 wherein the pH of said serum is increased to about pH 12.
Claim 22
Dependent Claim 33 words
The process according to claim 14 wherein said modifying step comprises treating the serum with a chaotropic agent for a time sufficient to inhibit the destabilizing activity of the components of the serum.
Claim 23
Dependent Claim 43 words
A stable natural matrix produced according to the process of claim 1 or claim 2 or produced according to the process of claim 11 or claim 12 or a stable serum-based matrix produced according to the process of claim 17 or claim 18.
Claim 24
Dependent Claim 51 words
A process for preparing a stable natural matrix for use in the measurement of antigen in a fluid sample by means of an immunoassay comprising modifying a biological carrier fluid for antigen obtained from a suitable mammal to inhibit the activity of components of said biologic fluid destabilizing to said antigen.
Claim 25
Dependent Claim 51 words
A process for preparing a stable natural matrix for use in the measurement of antigen in a fluid sample by means of an immunoassay comprising modifying a biological carrier fluid for antigen obtained from a suitable mammal to inhibit the activity of components of said biologic fluid destabilizing to said antigen.
Claim 26
Dependent Claim 11 words
The process according to claim 22 wherein said antigen is calcitonin.

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