US5206140A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Assay for soluble crosslinked fibrin polymers
Assignee: University of Rochester
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Filing: 1990-03-26
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Granted: 1993-04-27
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Expires: 2010-03-26
Abstract
Abstract This invention relates to an assay for fibrin polymers for use in the diagnosis of patients at risk of thrombosis and in monitoring the effects of treatment in such patients. More particularly, the present invention relates to an assay for soluble crosslinked fibrin polymers in patent samples involving the in vitro treatment of the sample with a proteolytic enzyme such as t-PA which generates the D-dimer fragment of soluble fibrin polymers. The amount of D-dimer formed is determined by an immunoassay specific for D-dimer. The measurement of D-dimer is thus a useful reflection of the hypercoagulability state and the test may be useful for assessing pre-thrombotic or thrombotic disorders such as myocardial infarction, pulmonary embolism and deep vein thrombosis, as well as for soluble fibrin formation in neoplastic, immune, inflammatory states, or other pathologic conditions, and for evaluations of therapy such as with anticoagulants that are used to treat these conditions.
Inventors
- 👤 Victor J. Marder
- 👤 Charles W. Francis
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 02:38
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/86; C; C12; C12Q; C12Q1/00; C12Q1/56; G01N2333/00; G01N2333/435; G01N2333/745; G01N2333/75; G01N2333/90; G01N2333/914; G01N2333/948; G01N2333/972; G01N2333/9726
Claims Analysis
Total Claims: 20
Claim 1
Independent Claim
43 words
A process for the in vitro determination of crosslinked soluble fibrin polymers in a patient sample which comprises contacting said sample with at least one proteolytic enzyme to generate the D-dimer fragment of said fibrin polymers and measuring the amount of said D-dimer.
Claim 2
Dependent Claim
43 words
A process for the in vitro determination of crosslinked soluble fibrin polymers in a patient sample which comprises contacting said sample with at least one proteolytic enzyme to generate the D-dimer fragment of said fibrin polymers and measuring the amount of said D-dimer.
Claim 3
Dependent Claim
64 words
A process for the in vitro determination of crosslinked soluble fibrin polymers in a patient sample which comprises (a) adding a plasminogen activator to said sample, wherein said plasminogen activator activates endogenous fibrin-bound plasminogen and converts the plasminogen to plasmin; (b) contacting said sample with exogenous plasminogen to generate the D-dimer fragment of said fibrin polymers; and (c) measuring the amount of said D-dimer.
Claim 4
Dependent Claim
64 words
A process for the in vitro determination of crosslinked soluble fibrin polymers in a patient sample which comprises (a) adding a plasminogen activator to said sample, wherein said plasminogen activator activates endogenous fibrin-bound plasminogen and converts the plasminogen to plasmin; (b) contacting said sample with exogenous plasminogen to generate the D-dimer fragment of said fibrin polymers; and (c) measuring the amount of said D-dimer.
Claim 5
Dependent Claim
13 words
The process according to claim 1 in which the proteolytic enzyme is plasminogen.
Claim 6
Dependent Claim
15 words
The process according to claim 1 in which the proteolytic enzyme is a plasminogen activator.
Claim 7
Dependent Claim
17 words
The process according to claim 1 in which the proteolytic enzymes are plasminogen and a plasminogen activator.
Claim 8
Dependent Claim
21 words
The process according to any one of claims 2, 4 or 5 in which the plasminogen activator is tissue plasminogen activator.
Claim 9
Dependent Claim
25 words
The process according to claim 2 or 5 in which an effective amount of the plasminogen is from about 1 unit/ml to about 10 units/ml.
Claim 10
Dependent Claim
24 words
The process according to claim 1 or 2 in which the amount of said D-dimer is measured by an immunoassay specific to said D-dimer.
Claim 11
Dependent Claim
24 words
The process according to claim 8 in which an antibody that is reactive with D-dimer preferentially over fibrin polymers is used in said immunoassay.
Claim 12
Dependent Claim
20 words
The process according to claim 8 in which a monoclonal antibody is used in said immunoassay to bind said D-dimer.
Claim 13
Dependent Claim
12 words
The process of claim 10 in which the monoclonal antibody is DD/3B6/22.
Claim 14
Dependent Claim
24 words
The process of claim 1 or 2 in which the amount of said D-dimer is measured by gel electrophoresis, thin-layer chromatography, or column chromatography.
Claim 15
Dependent Claim
68 words
A diagnostic kit for assaying the amount of D-dimer in a patient sample comprising a carrier being compartmented to receive a series of containers in close confinement which comprises: (a) a first container containing a measured amount of standard containing crosslinked soluble fibrin polymers, (b) a second container containing a measured amount of a proteolytic enzyme, and (c) A third container containing an antibody specific to said D-dimer.
Claim 16
Dependent Claim
68 words
A diagnostic kit for assaying the amount of D-dimer in a patient sample comprising a carrier being compartmented to receive a series of containers in close confinement which comprises: (a) a first container containing a measured amount of standard containing crosslinked soluble fibrin polymers, (b) a second container containing a measured amount of a proteolytic enzyme, and (c) A third container containing an antibody specific to said D-dimer.
Claim 17
Dependent Claim
14 words
A kit according to claim 13 in which the antibody is a monoclonal antibody.
Claim 18
Dependent Claim
13 words
A kit according to claim 13 in which the monoclonal antibody is DD/3B6/22.
Claim 19
Dependent Claim
15 words
A kit according to claim 13 in which the proteolytic enzyme is tissue plasminogen activator.
Claim 20
Dependent Claim
13 words
A kit according to claim 13 in which the proteolytic enzyme is plasmin.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1996-04-26 | 1996-10-26 | 1997-04-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-04-26 | 2000-10-26 | 2001-04-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-04-26 | 2004-10-26 | 2005-04-27 | $7700.00 | Window Closed / Lapsed |