Ex vivo product of conception test to determine abortion

• US 5,223,440 A
• Filed: 11/18/1988
• Issued: 06/29/1993
• Est. Priority Date: 11/17/1987
• Status: Expired due to Term

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Prenatal Products Corp. (Hologic Incorporated)
• Inventors: Senyei, Andrew E., Teng, Nelson N. H.
• Primary Examiner(s): Rosen, Sam
• Application Number:
  US07/274,267
• Time in Patent Office: 1,684 Days
• Field of Search: 435/7, 435/7.9, 435/7.93, 436/510, 436/518, 436/547, 436/548, 436/63, 436/65, 436/814
• US Class Current: 436/510
• CPC Class Codes: G01N 2800/368 Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
• CPC Class Codes: Y10S 436/814 Pregnancy

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.

Claims

1. 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.

2. The method of claim 1 wherein the sample is removed from the uterine cavity.

3. The method of claim 1 wherein the sample includes vaginal discharge during a suspected spontaneous abortion.

4. 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.

5. 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.

6. The method of claim 5 wherein the anti-(fetal restricted antigen class) antibody has a physically detectable label.

7. 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.

8. 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.

9. The method of claim 8 wherein the anti-(fetal restricted antigen) antibody has a physically detectable label.

10. 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.