Determining pregnancy induced hypertension and eclampsia by immunoassay of cellular fibronectin

• US 5,079,171 A
• Filed: 01/27/1989
• Issued: 01/07/1992
• Est. Priority Date: 09/15/1988
• Status: Expired due to Term

• Current Assignee: Aspen Diagnostics Corporation, 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:
  US07/302,854
• Time in Patent Office: 1,075 Days
• Field of Search: 436/510, 436/518, 436/536, 436/538, 436/547, 436/548, 436/63, 436/65, 436/811, 436/814
• US Class Current: 436/510
• CPC Class Codes: G01N 2800/321 Arterial hypertension
• CPC Class Codes: G01N 2800/368 Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
• CPC Class Codes: G01N 33/6887 from muscle, cartilage or connective tissue
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10S 436/814 Pregnancy

Abstract

Preeclampisa, pregnancy induced hypertension (PIH) and eclampsia are determined by identifying the presence of an endothelial cell marker in a sample of blood, plasma or serum of a pregnant woman using a sandwich or competition immunoassay. Cellular fibronectin marker in a sample is determined by binding with an anti-(cellular fibronectin) antibody. Reagents for these methods are also an aspect of the invention.

Claims

1. A method for determining preeclampsia, pregnancy induced hypertension or eclampsia comprising

a) contacting a blood, plasma or serum sample from a pregnant patient with an anti-(cellular fibronectin) antibody;

b) determining binding by said antibody to determine the presence of cellular fibronectin in the sample; and

c) comparing the presence of cellular fibronectin to a standard wherein an increase of said fibronectin is indicative of the presence of one of the above set forth physiological conditions.

2. The method of claim 1 comprising the steps of

a) contacting the sample with an insoluble support to which anti-(cellular 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.

3. The method of claim 2 wherein the anti-(fibronectin) antibody has a physically detectable label.

4. The method of claim 2 wherein the anti-(fibronectin) antibody is an anti-(cellular fibronectin) antibody.

5. The method of claim 4 wherein the anti-(cellular fibronectin) antibody adhered to the insoluble support is a first anti-(cellular fibronectin) antibody, and the anti-(fibronectin) antibody is a second anti-(cellular fibronectin) antibody which does not significantly cross-react with the first anti-(cellular fibronectin) antibody.

6. The method of claim 1 comprising the steps of

a) contacting a mixture of the sample and an anti-(fibronectin) antibody with an insoluble support to which an anti-(cellular fibronectin) antibody is adhered for a time sufficient to permit antigen-antibody binding to occur;

and

b) determining the presence of anti-(fibronectin) antibody on the insoluble support.

7. The method of claim 6 wherein the anti-(fibronectin) antibody has a physically detectable label.

8. The method of claim 6 wherein the anti-(cellular fibronectin) antibody is a first anti-(cellular fibronectin) antibody and the anti-(fibronectin) antibody is a second anti-(cellular fibronectin) antibody which does not significantly cross-react.

9. 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;

b) contacting the insoluble support with an anti-(cellular fibronectin) antibody for a time sufficient to permit antigen-antibody binding to occur; and

c) determining the presence of anti-(cellular fibronectin) antibody on the insoluble support.

10. The method of claim 9 wherein the anti-(cellular fibronectin) antibody has a physically detectable label.

11. The method of claim 1 comprising the steps of

a) contacting a mixture of the sample and an anti-(cellular fibronectin) antibody with an insoluble support to which an anti-(fibronectin) antibody is adhered for a time sufficient to permit antigen-antibody binding to occur;

and

b) determining the presence of anti-(cellular fibronectin) antibody on the insoluble support.

12. The method of claim 11 wherein the anti-(cellular fibronectin) antibody has a physically detectable label.

13. The method of claim 1 comprising

a) contacting an insoluble support to which an anti-(cellular fibronectin) antibody is adhered with a mixture of the sample and an amount of a labeled cellular fibronectin which is insufficient to bind with all of the anti-(cellular fibronectin) antibody adhered to the support;

and

b) determining the amount of labeled cellular fibronectin bound to the insoluble support or the amount of labeled cellular fibronectin remaining in the mixture.

14. The method of claim 1 comprising

a) contacting an insoluble support to which cellular fibronectin is adhered with a mixture of the sample and an amount of a labeled anti-(cellular fibronectin) antibody which is insufficient to bind with all of the cellular fibronectin adhered to the support;

and

b) determining the amount of labeled anti-(cellular fibronectin) antibody bound to the insoluble support or the amount of labeled anti-(cellular fibronectin) antibody remaining in the mixture.