US4738932A
Expired / Lapsed
US
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Reaginic test for syphilis
Assignee: Heron Therapeutics LLC
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Filing: 1985-12-03
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Granted: 1988-04-19
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Expires: 2005-12-03
Abstract
Abstract A reaginic agglutination test for syphilis-associated antibodies is disclosed. The test uses an antigen reagent that comprises a buffered aqueous suspension of cardiolipin antigen ionically coupled to latex particles via a polypeptide bridge. Positive sera react with the antigen reagent and yield an agglutination pattern characterized by medium to large aggregates. Negative sera yield no agglutinated particles.
Inventors
- 👤 Kenichi K. Yabusaki
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 18:19
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/569; G01N33/571; G01N33/54313; G01N33/54353; G01N33/54393; Y; Y10; Y10S; Y10S435/00; Y10S435/81; Y10S436/00; Y10S436/807; Y10S436/808; Y10S436/811
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
29 words
An antigen reagent for use in a reaginic test for syphilis comprising an aqueous suspension of cardiolipin antigen ionically coupled to latex particles via a positively charged polypeptide bridge.
Claim 2
Dependent Claim
29 words
An antigen reagent for use in a reaginic test for syphilis comprising an aqueous suspension of cardiolipin antigen ionically coupled to latex particles via a positively charged polypeptide bridge.
Claim 3
Dependent Claim
21 words
The reagent of claim 1 wherein the latex particles are neutral or modified to have negatively charged or reactive surface moieties.
Claim 4
Dependent Claim
21 words
The reagent of claim 1 wherein the particle size of the latex is in the range of 0.1 to 7 microns.
Claim 5
Dependent Claim
21 words
The reagent of claim 1 wherein the particle size of the latex is in the range of 0.4 to 0.8 microns.
Claim 6
Dependent Claim
13 words
The reagent of claim 1 wherein the polypeptide is a polycationic polyamino acid.
Claim 7
Dependent Claim
10 words
The reagent of claim 1 wherein the polypeptide is polylysine.
Claim 8
Dependent Claim
21 words
The reagent of claim 1 wherein the cardiolipin antigen is an ethanol solution of 0.03% cardiolipin, 0.9% cholesterol and 0.21% lecithin.
Claim 9
Dependent Claim
19 words
The reagent of claim 1 wherein the aqueous suspension is buffered to a pH in the range of 5-10.
Claim 10
Dependent Claim
18 words
The reagent of claim 1 wherein the aqueous suspension is buffered at a pH of 6.0 to 7.0.
Claim 11
Dependent Claim
87 words
The reagent of claim 1 wherein the particle size of the latex is in the range of 0.4 to 0.8 microns, the latex is a carboxylated latex, the polypeptide bridge is a methylated serum albumin or polylysine bridge, the cardiolipin antigen is an ethanol solution of 0.03% cardiolipin, 0.9% cholesterol and 0.21% lecithin, the suspension is buffered to a pH of 6.0 to 6.5, and the concentration of cardiolipin antigen ionically coupled to latex particles via a polypeptide bridge in the suspension is 0.3 to 0.9 mg/ml.
Claim 12
Dependent Claim
56 words
A reaginic test for syphilis-associated antibodies comprising: (a) incubating a sample suspected of containing said antibodies with the antigen reagent of claim 1 under conditions that permit binding between said antibodies and antigen in said antigen reagent; and (b) determining whether the antigen reagent has agglutinated, agglutination indicating the presence of said antibodies in said sample.
Claim 13
Dependent Claim
56 words
A reaginic test for syphilis-associated antibodies comprising: (a) incubating a sample suspected of containing said antibodies with the antigen reagent of claim 5 under conditions that permit binding between said antibodies and antigen in said antigen reagent; and (b) determining whether the antigen reagent has agglutinated, agglutination indicating the presence of said antibodies in said sample.
Claim 14
Dependent Claim
56 words
A serologic test for syphilis-associated antibodies comprising: (a) incubating a sample suspected of containing said antibodies with the antigen reagent of claim 6 under conditions that permit binding between said antibodies and antigen in said antigen reagent; and (b) determining whether the antigen reagent has agglutinated, agglutination indicating the presence of said antibodies in said sample.
Claim 15
Dependent Claim
56 words
A serologic test for syphilis-associated antibodies comprising: (a) incubating a sample suspected of containing said antibodies with the antigen reagent of claim 7 under conditions that permit binding between said antibodies and antigen in said antigen reagent; and (b) determining whether the antigen reagent has agglutinated, agglutination indicating the presence of said antibodies in said sample.
Claim 16
Dependent Claim
56 words
A serologic test for syphilis-associated antibodies comprising: (a) incubating a sample suspected of containing said antibodies with the antigen reagent of claim 8 under conditions that permit binding between said antibodies and antigen in said antigen reagent; and (b) determining whether the antigen reagent has agglutinated, agglutination indicating the presence of said antibodies in said sample.
Claim 17
Dependent Claim
56 words
A serologic test for syphilis-associated antibodies comprising: (a) incubating a sample suspected of containing said antibodies with the antigen reagent of claim 10 under conditions that permit binding between said antibodies and antigen in said antigen reagent; and (b) determining whether the antigen reagent has agglutinated, agglutination indicating the presence of said antibodies in said sample.
Claim 18
Dependent Claim
70 words
A kit for conducting a serologic test for syphilis-associated antibodies comprising, in packaged combination: (a) a first container containing the antigen reagent of claim 1; (b) a second container containing a negative control sample of serum, plasma, or cerebrospinal fluid that does not react with the antigen reagent; and (c) a third container containing a positive control sample of serum, plasma, or cerebrospinal fluid that reacts with the antigen reagent.
Claim 19
Dependent Claim
70 words
A kit for conducting a serologic test for syphilis-associated antibodies comprising, in packaged combination: (a) a first container containing the antigen reagent of claim 5; (b) a second container containing a negative control sample of serum, plasma, or cerebrospinal fluid that does not react with the antigen reagent; and (c) a third container containing a positive control sample of serum, plasma, or cerebrospinal fluid that reacts with the antigen reagent.
Claim 20
Dependent Claim
70 words
A kit for conducting a serologic test for syphilis-associated antibodies comprising, in packaged combination: (a) a first container containing the antigen reagent of claim 6; (b) a second container containing a negative control sample of serum, plasma, or cerebrospinal fluid that does not react with the antigen reagent; and (c) a third container containing a positive control sample of serum, plasma, or cerebrospinal fluid that reacts with the antigen reagent.
Claim 21
Dependent Claim
70 words
A kit for conducting a serologic test for syphilis-associated antibodies comprising, in packaged combination: (a) a first container containing the antigen reagent of claim 7; (b) a second container containing a negative control sample of serum, plasma, or cerebrospinal fluid that does not react with the antigen reagent; and (c) a third container containing a positive control sample of serum, plasma, or cerebrospinal fluid that reacts with the antigen reagent.
Claim 22
Dependent Claim
70 words
A kit for conducting a serologic test for syphilis-associated antibodies comprising, in packaged combination: (a) a first container containing the antigen reagent of claim 8; (b) a second container containing a negative control sample of serum, plasma, or cerebrospinal fluid that does not react with the antigen reagent; and (c) a third container containing a positive control sample of serum, plasma, or cerebrospinal fluid that reacts with the antigen reagent.
Claim 23
Dependent Claim
70 words
A kit for conducting a serologic test for syphilis-associated antibodies comprising, in packaged combination: (a) a first container containing the antigen reagent of claim 10; (b) a second container containing a negative control sample of serum, plasma, or cerebrospinal fluid that does not react with the antigen reagent; and (c) a third container containing a positive control sample of serum, plasma, or cerebrospinal fluid that reacts with the antigen reagent.
Claim 24
Dependent Claim
12 words
The reagent of claim 1 wherein the polypeptide is methylated serum albumin.
Claim 25
Dependent Claim
56 words
A reaginic test for syphilis-associated antibodies comprising: (a) incubating a sample suspected of containing said antibodies with the antigen reagent of claim 23 under conditions that permit binding between said antibodies and antigen in said antigen reagent; and (b) determining whether the antigen reagent has agglutinated, agglutination indicating the presence of said antibodies in said sample.
Claim 26
Dependent Claim
70 words
A kit for conducting a serologic test for syphilis-associated antibodies comprising, in packaged combination: (a) a first container containing the antigen reagent of claim 23; (b) a second container containing a negative control sample of serum, plasma, or cerebrospinal fluid that does not react with the antigen reagent; and (c) a third container containing a positive control sample of serum, plasma, or cerebrospinal fluid that reacts with the antigen reagent.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1991-04-19 | 1991-10-19 | 1992-04-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1995-04-19 | 1995-10-19 | 1996-04-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1999-04-19 | 1999-10-19 | 2000-04-19 | $7700.00 | Window Closed / Lapsed |