US4666831A
Expired / Lapsed
US
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Lipid-dependent diagnostic assays
Assignee: Elan Pharmaceuticals LLC
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Filing: 1985-02-19
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Granted: 1987-05-19
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Expires: 2005-02-19
Abstract
Abstract Improved lipid-dependent diagnostic assays are provided wherein the test sample to be assayed is pre-incubated with one or more phospholipids having a hexagonal (H II ) organization or with lipidic particles. The pre-incubation results in reduced false positives due to anti-phospholipid antibodies, such as, lupus anticoagulants, which may be present in the test sample, without changing the overall character, including the normal baseline, of the assay. Suprisingly, in accordance with the invention, it has been found that only hexagonal phospholipids and lipidic particles can be used, and, in particular, lamellar (bilayer) phospholipids cannot be used. An assay for diagnosing systemic lupus erythematosus (SLE) is also provided.
Inventors
- 👤 Andrew S. Janoff
- 👤 Joyce Rauch
- 👤 Colin P. S. Tilcock
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 20:49
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/92; G01N33/86; G01N2405/00; G01N2405/04; Y; Y10; Y10S; Y10S436/00; Y10S436/811; Y10S436/825; Y10T; Y10T436/00; Y10T436/25; Y10T436/25125
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
45 words
In a lipid-dependent diagnostic assay which is performed on a test sample and which is subject to false positives if the test sample includes anti-phospholipid antibodies, the improvement comprising pre-incubating the test sample with one or more phospholipids having a hexagonal (H II ) organization.
Claim 2
Dependent Claim
45 words
In a lipid-dependent diagnostic assay which is performed on a test sample and which is subject to false positives if the test sample includes anti-phospholipid antibodies, the improvement comprising pre-incubating the test sample with one or more phospholipids having a hexagonal (H II ) organization.
Claim 3
Dependent Claim
21 words
The assay of claim 1 wherein the phospholipids are selected from the group consisting of bovine phosphatidylethanolamine, egg phosphatidylethanolamine, and dioleoylphosphatidylethanolamine.
Claim 4
Dependent Claim
10 words
The assay of claim 2 wherein the phospholipid is dioleoylphosphatidylethanolamine.
Claim 5
Dependent Claim
11 words
The assay of claim 2 wherein the phospholipid is egg phosphatidylethanolamine.
Claim 6
Dependent Claim
19 words
The assay of claim 1 wherein the test sample is human plasma and the assay is a coagulation test.
Claim 7
Dependent Claim
14 words
The assay of claim 5 wherein the assay is a partial thromboplastin time assay.
Claim 8
Dependent Claim
19 words
The assay of claim 1 wherein the test sample is human plasma and the assay is a syphilis test.
Claim 9
Dependent Claim
13 words
The assay of claim 7 wherein the assay is a cardiolipin-dependent syphilis test.
Claim 10
Dependent Claim
36 words
In a lipid-dependent diagnostic assay which is performed on a test sample and which is subject to false positives if the test sample includes anti-phospholipid antibodies, the improvement comprising pre-incubating the test sample with lipidic particles.
Claim 11
Dependent Claim
36 words
In a lipid-dependent diagnostic assay which is performed on a test sample and which is subject to false positives if the test sample includes anti-phospholipid antibodies, the improvement comprising pre-incubating the test sample with lipidic particles.
Claim 12
Dependent Claim
19 words
The assay of claim 9 wherein the test sample is human plasma and the assay is a coagulation test.
Claim 13
Dependent Claim
14 words
The assay of claim 10 wherein the assay is a partial thromboplastin time assay.
Claim 14
Dependent Claim
19 words
The assay of claim 9 wherein the test sample is human plasma and the assay is a syphilis test.
Claim 15
Dependent Claim
13 words
The assay of claim 12 wherein the assay is a cardiolipin-dependent syphilis test.
Claim 16
Dependent Claim
118 words
An assay for use in determining whether a patient has systemic lupus erythematosus comprising the steps of: (a) obtaining first and second samples of the patient's plasma; (b) incubating the first sample with one or more phospholipids having a hexagonal (H II ) organization or with lipidic particles; (c) performing a lipid-dependent diagnostic assay on both the first and second samples, the assay producing a positive reading when used to assay a sample which contains anti-phospholipid antibodies; (d) comparing the results of the assays performed on the first and second samples, the presence of a normal result for the first sample and a positive result for the second sample being indicative of the patient having systemic lupus erythematosus.
Claim 17
Dependent Claim
118 words
An assay for use in determining whether a patient has systemic lupus erythematosus comprising the steps of: (a) obtaining first and second samples of the patient's plasma; (b) incubating the first sample with one or more phospholipids having a hexagonal (H II ) organization or with lipidic particles; (c) performing a lipid-dependent diagnostic assay on both the first and second samples, the assay producing a positive reading when used to assay a sample which contains anti-phospholipid antibodies; (d) comparing the results of the assays performed on the first and second samples, the presence of a normal result for the first sample and a positive result for the second sample being indicative of the patient having systemic lupus erythematosus.
Claim 18
Dependent Claim
13 words
The assay of claim 14 wherein the lipid-dependent assay is a coagulation test.
Claim 19
Dependent Claim
15 words
The assay of claim 15 wherein the lipid-dependent assay is a partial thromboplastin time assay.
Claim 20
Dependent Claim
13 words
The assay of claim 14 wherein the lipid-dependent assay is a syphilis test.
Claim 21
Dependent Claim
14 words
The assay of claim 17 wherein the lipid-dependent assay is a cardiolipin-dependent syphilis test.
Claim 22
Dependent Claim
21 words
The assay of claim 14 wherein the phospholipids are selected from the group consisting of bovine phosphatidylethanolamine, egg phosphatidylethanolamine, and dioleoylphosphatidylethanolamine.
Claim 23
Dependent Claim
10 words
The assay of claim 19 wherein the phospholipid is dioleoylphosphatidylethanolamine.
Claim 24
Dependent Claim
11 words
The assay of claim 19 wherein the phospholipid is egg phosphatidylethanolamine.
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) | 1990-05-18 | 1990-11-17 | 1991-05-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-05-18 | 1994-11-17 | 1995-05-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-05-18 | 1998-11-17 | 1999-05-19 | $7700.00 | Window Closed / Lapsed |