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US5096830A Expired / Lapsed US ⏱️ 0.0 years remaining

Preterm labor and membrane rupture test

Assignee: ASPEN DIAGNOSTICS Corp A CORP OF
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Filing: 1988-09-15
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Granted: 1992-03-17
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Expires: 2008-09-15
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Abstract

Abstract A method for determining increased risk of labor and fetal membrane rupture after week 20 of pregnancy comprises obtaining a secretion sample from the vaginal cavity; and determining the presence of a fetal restricted antigen in the sample. The sample can be removed from anywhere in the vaginal cavity, but is preferably removed from the posterior fornix or and/or cervical os. 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, the class of substances of which the fetal restricted antigen is a member is captured with a general binding antibody (such as anti-human fibronectin antibody), anti-(fetal restricted antigen) antibody (such as anti-fetal fibronectin antibody) is conjugated with the support, and binding with fetal restricted antigen is determined. Reagents and reagent kits are also included.

Inventors

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

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-29 22:02
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; Y; Y10; Y10S; Y10S436/00; Y10S436/811; Y10S436/814

Claims Analysis

Total Claims: 15
Claim 1
Independent Claim 57 words
A method for determining signs and symptoms indicating risk of delivery comprising a) obtaining a secretion sample from the vaginal cavity or the cervical canal for a pregnant patient after week 20 of pregnancy; and b) determining the presence of fetal fibronectin in the sample, the presence of fetal fibronectin in the sample indicating risk of delivery.
Claim 2
Independent Claim 57 words
A method for determining signs and symptoms indicating risk of delivery comprising a) obtaining a secretion sample from the vaginal cavity or the cervical canal for a pregnant patient after week 20 of pregnancy; and b) determining the presence of fetal fibronectin in the sample, the presence of fetal fibronectin in the sample indicating risk of delivery.
Claim 3
Dependent Claim 14 words
The method of claim 1 wherein the sample is removed from the posterior fornix.
Claim 4
Dependent Claim 14 words
The method of claim 1 wherein the sample is obtained from the cervical os.
Claim 5
Dependent Claim 36 words
The method of claim 1 comprising the steps of a) contacting diluted sample with an anti-(fetal fibronectin) antibody for a time sufficient to permit antigen-antibody binding to occur; and b) determining the presence of said binding.
Claim 6
Dependent Claim 65 words
He 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; b) contacting the insoluble support with an anti-fibronectin antibody for a time sufficient to permit antigen-antibody binding to occur; and c) determining the presence of anti-fibronectin antibody on the insoluble support.
Claim 7
Dependent Claim 14 words
The method of claim 5 wherein the anti-fibronectin antibody has a physically detectable label.
Claim 8
Dependent Claim 42 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 selectively with the anti-fibronectin antibody; and b) determining the presence of the label on the insoluble support.
Claim 9
Dependent Claim 66 words
He 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; b) contacting the insoluble support with an anti-(fetal fibronectin) antibody for a time sufficient to permit antigen-antibody binding to occur; and c) determining the presence of anti-(fetal fibronectin) antibody on the insoluble support.
Claim 10
Dependent Claim 15 words
The method of claim 8 wherein the anti-(fetal fibronectin) antibody has a physically detectable label.
Claim 11
Dependent Claim 44 words
The method of claim 8 wherein the presence of anti-(fetal fibronectin) antibody is determined by a) contacting the insoluble support with a labelled antibody which binds selectively with the anti-(fetal fibronectin) antibody; and b) determining the presence of the label on the insoluble support.
Claim 12
Dependent Claim 10 words
The method of claim 1 wherein said method determines labor.
Claim 13
Dependent Claim 12 words
The method of claim 1 wherein said method determines fetal membrane rupture.
Claim 14
Dependent Claim 13 words
The method of claim 1 wherein said pregnant patient is a preterm patient.
Claim 15
Dependent Claim 13 words
The method of claim 1 wherein said pregnant patient is a term patient.

References Cited (Backward Citations)

US3271257A Cited
US4279992A 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) 1995-03-17 1995-09-16 1996-03-17 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1999-03-17 1999-09-16 2000-03-17 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2003-03-17 2003-09-16 2004-03-17 $7700.00 Window Closed / Lapsed

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