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US5223440A Expired / Lapsed US ⏱️ 0.0 years remaining

Ex vivo product of conception test to determine abortion

Assignee: ASPEN DIAGNOSTICS Corp ACORP OF
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Filing: 1988-11-18
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Granted: 1993-06-29
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Expires: 2008-11-18
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Abstract

Abstract The invention provides a method for determining the presence of products of conception in a sample derived from the uterus during a D&C, or a therapeutic or spontaneous abortion, and comprises determining the presence in the sample of a fetal restricted antigen, which is found in products of conception but not found in significant amounts in maternal plasma or serum. Since the fetal restricted antigen is not present in significant quantities in maternal plasma or serum, the methods of this invention are reliable even when the sample is contaminated with maternal blood. One fetal restricted antigen is fetal fibronectin. In one embodiment of this invention, the sample is contacted with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered, and the fetal restricted antigen binding to the support is determined. Alternatively, an antibody which binds a class of substances of which the fetal restricted antigen is a member can be substituted for either the capture antbody or the sandwiching antibody, and binding of fetal restricted antigen is determined. Competition assay procedures can also be used. Reagents and reagent kits are included.

Inventors

  • 👤 Nelson N. H. Teng
  • 👤 Andrew E. Senyei

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-30 02:57
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/74; G01N33/76; G01N33/68; G01N33/689; G01N2800/00; G01N2800/36; G01N2800/368; Y; Y10; Y10S; Y10S436/00; Y10S436/811; Y10S436/814

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 65 words
A method for confirming the presence of the ex vivo products of conception in a sample obtained from a therapeutic abortion or suspected spontaneous abortion comprising determining the presence of a significant amount of fetal fibronectin in the sample in comparison to a negative control, the presence of a significant amount of fetal fibronectin indicating the presence of the products of conception in the sample.
Claim 2
Independent Claim 65 words
A method for confirming the presence of the ex vivo products of conception in a sample obtained from a therapeutic abortion or suspected spontaneous abortion comprising determining the presence of a significant amount of fetal fibronectin in the sample in comparison to a negative control, the presence of a significant amount of fetal fibronectin indicating the presence of the products of conception in the sample.
Claim 3
Dependent Claim 14 words
The method of claim 1 wherein the sample is removed from the uterine cavity.
Claim 4
Dependent Claim 16 words
The method of claim 1 wherein the sample includes vaginal discharge during a suspected spontaneous abortion.
Claim 5
Dependent Claim 37 words
The method of claim 1 comprising the steps of a) contacting the sample with an anti-(fetal restricted antigen) antibody for a time sufficient to permit antigen-antibody binding to occur; and b) determining the presence of said binding.
Claim 6
Dependent Claim 80 words
The method of claim 4 comprising the steps of a) contacting the sample with an insoluble support to which anti-(fetal fibronectin) 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-fibronectin antibody for a time sufficient to permit antigen-antibody binding to occur, and removing unbound anti-fibronectin antibody from the support; and c) determining the presence of anti-fibronectin antibody on the insoluble support.
Claim 7
Dependent Claim 17 words
The method of claim 5 wherein the anti-(fetal restricted antigen class) antibody has a physically detectable label.
Claim 8
Dependent Claim 50 words
The method of claim 5 wherein the presence of anti-fibronectin antibody is determined by a) contacting the insoluble support with a labeled antibody which binds preferentially with the anti-fibronectin antibody and removing unbound labeled antibody from the support; and b) determining the presence of the label on the insoluble support.
Claim 9
Dependent Claim 82 words
The method of claim 1 comprising the steps of a) contacting the sample with an insoluble support to which anti-fibronectin 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 fibronectin) antibody for a time sufficient to permit antigen-antibody binding to occur, and removing unbound anti-(fetal fibronectin) antibody from the support; and c) determining the presence of anti-(fetal fibronectin) antibody on the insoluble support.
Claim 10
Dependent Claim 16 words
The method of claim 8 wherein the anti-(fetal restricted antigen) antibody has a physically detectable label.
Claim 11
Dependent Claim 52 words
The method of claim 8 wherein the presence of anti-(fetal fibronectin) antibody is determined by a) contacting the insoluble support with a labeled antibody which binds preferentially with the anti-(fetal fibronectin) antibody, and removing unbound labeled antibody from the support; and b) determining the presence of the label on the insoluble support.

References Cited (Backward Citations)

US4279992A Cited
US4325867A Cited
US4486530A Cited
SU1107051A1 Cited
JPS6091264A Cited
US4675286A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1996-06-28 1996-12-28 1997-06-29 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2000-06-28 2000-12-28 2001-06-29 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2004-06-28 2004-12-28 2005-06-29 $7700.00 Window Closed / Lapsed

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