Patent EP0316919A2 successfully refreshed from Google Patents.
EP0316919A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Vaginal sample test and reagents
Assignee: Adeza Biomedical Corp
•
Filing: 1988-11-17
•
Granted: —
•
Expires: 2008-11-17
Abstract
Abstract Methods, reagents and kits for detection of normal or ectopic pregnancy, the termination of pregnancy, or increased risk of preterm labor and rupture of membranes. Each embodiment involves sampling from the vaginal cavity, and determining the presence or absence of a specific analyte in the test sample. Sandwich or competition assay procedures can be used. Reagents and reagent kits for the above assays are included.
Inventors
- 👤 Nelson N.H. Teng
- 👤 Andrew E. Senyei
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-30 10:21
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/68; G01N33/689; G01N33/74; G01N33/76; G01N2800/00; G01N2800/36; G01N2800/368
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
228 words
A method to determine the presence of a diagnostic indicator in a sample derived from the vaginal cavity, comprising: (a) a method for determining pregnancy during the first trimester comprising obtaining a test sample in the vicinity of the cervical canal or cervical os, and determining the presence of a nonrestricted pregnancy antigen in the sample; (b) a method for determining normal uterine pregnancy during the first 20 weeks of pregnancy comprising obtaining a test sample in the vicinity of the cervical canal or cervical os, and determining the presence of a fetal restricted antigen in the sample; (c) a method for determining fallopian pregnancy comprising obtaining a test sample in the vicinity of the cervical canal or cervical os from a pregnant patient during the first 20 weeks of pregnancy, and determining the absence of a fetal restricted antigen in the sample; (d) a method for determining ex vivo products of conception comprising obtaining a test sample expelled or removed from the uterus, and determining the presence of a fetal restricted antigen in the sample; or (e) a method for determining increased risk of preterm labor or fetal membrane rupture comprising obtaining a test sample in the vicinity of the posterior fornix, cervical canal or cervical os, from a patient after week 20 of pregnancy, and determining the presence of a fetal restricted antigen in the sample.
Claim 2
Independent Claim
228 words
A method to determine the presence of a diagnostic indicator in a sample derived from the vaginal cavity, comprising: (a) a method for determining pregnancy during the first trimester comprising obtaining a test sample in the vicinity of the cervical canal or cervical os, and determining the presence of a nonrestricted pregnancy antigen in the sample; (b) a method for determining normal uterine pregnancy during the first 20 weeks of pregnancy comprising obtaining a test sample in the vicinity of the cervical canal or cervical os, and determining the presence of a fetal restricted antigen in the sample; (c) a method for determining fallopian pregnancy comprising obtaining a test sample in the vicinity of the cervical canal or cervical os from a pregnant patient during the first 20 weeks of pregnancy, and determining the absence of a fetal restricted antigen in the sample; (d) a method for determining ex vivo products of conception comprising obtaining a test sample expelled or removed from the uterus, and determining the presence of a fetal restricted antigen in the sample; or (e) a method for determining increased risk of preterm labor or fetal membrane rupture comprising obtaining a test sample in the vicinity of the posterior fornix, cervical canal or cervical os, from a patient after week 20 of pregnancy, and determining the presence of a fetal restricted antigen in the sample.
Claim 3
Dependent Claim
41 words
The method of Claim 1 for determining pregnancy during the first trimester comprising (a) obtaining a test sample in the vicinity of the cervical canal or cervical os, and (b) determining the presence of a nonrestricted pregnancy antigen in the sample.
Claim 4
Dependent Claim
46 words
The method of Claim 1 for determining normal uterine pregnancy during the first 20 weeks of pregnancy comprising (a) obtaining a test sample in the vicinity of the cervical canal or cervical os, and (b) determining the presence of a fetal restricted antigen in the sample.
Claim 5
Dependent Claim
49 words
The method of Claim 1 for determining ectopic pregnancy comprising (a) obtaining a test sample in the vicinity of the cervical canal or cervical os from a pregnant patient during the first 20 weeks of pregnancy, and (b) determining the absence of a fetal restricted antigen in the sample.
Claim 6
Dependent Claim
37 words
The method of Claim 1 for determining ex vivo products of conception comprising (a) obtaining a test sample expelled or removed from the uterus, and (b) determining the presence of a fetal restricted antigen in the sample.
Claim 7
Dependent Claim
55 words
The method of Claim 1 for determining increased risk of preterm labor or fetal membrane rupture comprising (a) obtaining a test sample in the vicinity of the posterior fornix, cervical canal or cervical os, from a patient after week 20 of pregnancy, and (b) determining the presence of a fetal restricted antigen in the sample.
Claim 8
Dependent Claim
35 words
The method of Claim 1 or 2 comprising a) contacting the sample with an anti-(pregnancy antigen) antibody for a time sufficient to permit antigen-antibody binding to occur; and b) determining the presence of said binding.
Claim 9
Dependent Claim
86 words
The method of Claim 1, 2, or 7 comprising the steps of a) contacting the sample with an insoluble support to which anti-(pregnancy antigen) antibody is adhered for a time sufficient to permit antigen-antibody binding to occur, and removing the sample from the support; b) contacting the insoluble support with an anti-(pregnancy antigen) antibody for a time sufficient to permit antigen-antibody binding to occur, and removing unbound anti-(pregnancy antigen) antibody from the support; and c) determining the presence of anti-(pregnancy antigen) antibody on the insoluble support.
Claim 10
Dependent Claim
98 words
The method of Claim 1, 3, 4, 5, or 6 comprising the steps of a) contacting the sample with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered for a time sufficient to permit antigen-antibody binding to occur, and removing the sample from the support; b) contacting the insoluble support with an anti-(fetal restricted antigen) antibody or anti-(fetal restricted antigen class) antibody for a time sufficient to permit antigen-antibody binding to occur, and removing unbound anti-(fetal restricted antigen) antibody from the support; and c) determining the presence of anti-(fetal restricted antigen) antibody on the insoluble support.
Claim 11
Dependent Claim
93 words
The method of Claim 1, 3, 4, 5, or 6 comprising the steps of a) contacting the sample with an insoluble support to which anti-(fetal restricted antigen class) antibody is adhered for a time sufficient to permit antigen-antibody binding to occur, and removing the sample from the support; b) contacting the insoluble support with an anti-(fetal restricted antigen) antibody for a time sufficient to permit antigen-antibody binding to occur, and removing unbound anti-(fetal restricted antigen) antibody from the support; and c) determining the presence of anti-(fetal restricted antigen) antibody on the insoluble support.
Claim 12
Dependent Claim
45 words
The method of Claim 1, 2, 7 or 8 wherein the pregnancy antigen is selected from the group consisting of hCG, hCT, hPL, SP1, PAPP-A, PAPP-B, HSAP, PLAP, CAP, PP5, PAMG₁, PAMG₂, β₁-PAM, α₂-PAM, hCLRF, α-fetoprotein, EPF, MP1, PP13, PP17, PP20, somatostatin, and mixtures thereof.
Claim 13
Dependent Claim
24 words
The method of Claim 1, 3, 4, 5, 6, 9, or 10 wherein the fetal restricted antigen determined in the sample is fetal fibronectin.
Claim 14
Dependent Claim
20 words
The method of Claim 8, 9 or 10 wherein the reagent antibody of step (b) has a physically detectable label.
Claim 15
Dependent Claim
70 words
A pregnancy antigen testing kit comprising combinations of a sampling device with (a) an anti-(pregnancy antigen) antibody adhered to an insoluble support; (b) a combination of anti-(pregnancy antigen) antibody adhered to an insoluble support, and either a labeled anti-(pregnancy antigen) antibody, a labeled anti-(pregnancy antigen class) antibody, or a labeled reagent pregnancy antigen; or (c) a reagent pregnancy antigen adhered to an insoluble support and a labeled anti-(pregnancy antigen) antibody.
Claim 16
Dependent Claim
70 words
A pregnancy antigen testing kit comprising combinations of a sampling device with (a) an anti-(pregnancy antigen) antibody adhered to an insoluble support; (b) a combination of anti-(pregnancy antigen) antibody adhered to an insoluble support, and either a labeled anti-(pregnancy antigen) antibody, a labeled anti-(pregnancy antigen class) antibody, or a labeled reagent pregnancy antigen; or (c) a reagent pregnancy antigen adhered to an insoluble support and a labeled anti-(pregnancy antigen) antibody.
Claim 17
Dependent Claim
110 words
A kit for determining fetal restricted antigen in a test sample comprising (a) an anti-(fetal restricted antigen) antibody, an anti-(fetal restricted antigen class) antibody, or reagent fetal restricted antigen adhered to an insoluble support; (b) a combination of anti-(fetal restricted antigen) antibody adhered to an insoluble support, and either a labeled anti-(fetal restricted antigen) antibody, a labeled anti-(fetal restricted antigen class) antibody, or a labeled reagent fetal restricted antigen; (c) a combination of anti-(fetal restricted antigen class) antibody adhered to an insoluble support together with a labeled anti-(fetal restricted antigen) antibody; or (d) a reagent fetal restricted antigen adhered to an insoluble support and a labeled anti-(fetal restricted antigen) antibody.
Claim 18
Dependent Claim
110 words
A kit for determining fetal restricted antigen in a test sample comprising (a) an anti-(fetal restricted antigen) antibody, an anti-(fetal restricted antigen class) antibody, or reagent fetal restricted antigen adhered to an insoluble support; (b) a combination of anti-(fetal restricted antigen) antibody adhered to an insoluble support, and either a labeled anti-(fetal restricted antigen) antibody, a labeled anti-(fetal restricted antigen class) antibody, or a labeled reagent fetal restricted antigen; (c) a combination of anti-(fetal restricted antigen class) antibody adhered to an insoluble support together with a labeled anti-(fetal restricted antigen) antibody; or (d) a reagent fetal restricted antigen adhered to an insoluble support and a labeled anti-(fetal restricted antigen) antibody.
Claim 19
Dependent Claim
14 words
A kit of Claim 14 or 15 further including a labeled anti-(sandwiching antibody) antibody.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.