Diagnostic method for screening complement regulatory protein levels to predict spontaneous abortion

• US 7,008,775 B2
• Filed: 11/12/2002
• Issued: 03/07/2006
• Est. Priority Date: 05/15/2000
• Status: Expired due to Fees

• Current Assignee: The Board of Regents of the University of Colorado (University of Colorado System)
• Original Assignee: The Board of Regents of the University of Colorado (University of Colorado System)
• Inventors: Kaul, Anil K., Martens, Mark G., Kaul, Rashmi
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): CHEU, CHANGHWA J
• Application Number:
  US10/291,992
• Publication Number:
  US 20030129674A1
• Time in Patent Office: 1,211 Days
• Field of Search: 435/7.1, 435/7.2, 435/91.1, 435/92.1, 436/510, 436/517, 436/65
• US Class Current: 435/7.1
• CPC Class Codes: C07K 16/2896 against molecules with a "CD"-designation, not provided for elsewhere
• 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

Abstract

The invention provides a method for the early detection of pregnancy failure, spontaneous abortion or premature birth by determinations of complement regulatory protein levels. A kit for use in rapid identification of these pregnancy complications is also provided.

Claims

1. A method for diagnosing a predisposition for pregnancy failure or spontaneous abortion in a pregnant patient comprising:

(a) measuring CD55 levels in a physiological fluid in a pregnant patient, wherein the CD55 levels are measured by measuring levels of complexes formed by contacting the physiological fluid with an anti-CD55 antibody; and

b) determining whether CD55 levels in the physiological fluid of the patient are reduced relative to CD55 levels in a pregnant female patient not at risk of pregnancy failure or spontaneous abortion, wherein reduced CD55 levels are indicative for a predisposition for pregnancy failure or spontaneous abortion.

2. The method of claim 1, wherein the anti-CD55 antibody is immobilized on a solid surface.

3. The method of claim 1, wherein the anti-CD55 antibody comprises a detectable label or a binding site for a detectable label to form detectable complexes.

4. The method of claim 3 wherein the detectable label is an enzyme label.

5. The method of claim 4 wherein the detectable label is a fluorogenic compound.

6. The method of claim 3 wherein the binding site for the detectable label is biotin, avidin or streptavidin.

7. The method of claim 3 wherein the levels of the complexes have an optical density (OD) level below 14.

8. The method of claim 7 wherein the OD level is below 10.

9. A method for diagnosing a predisposition for pregnancy failure, spontaneous abortion or premature birth in a pregnant patient comprising:

(a) providing a sample obtained by contacting a physiological fluid from the patient, wherein the fluid potentially comprises a CRP from the patient, with a solid surface having immobilized thereon anti-CD55 antibodies, so that CRP present in the fluid binds to the anti-CD55 antibodies;

(b) contacting the sample with labelled CD55, which comprises a detectable label or a binding site for a detectable label, so that the labeled CD55 binds to free antibodies on the solid surface to form detectable complexes; and

(c) detecting the complexes, wherein the quantity of the complexes is inversely proportional to the amount of CD55 in the physiological fluid, and wherein a reduced quantity of CD55-antibody complexes in the patient relative to a corresponding control is indicative for a predisposition for pregnancy failure, spontaneous abortion or premature birth.

10. The method of claim 9 wherein the detectable label is an enzyme label.

11. The method of claim 9 wherein the detectable label is a fluorogenic compound.

12. The method of claim 9 wherein the binding site for the detectable label is biotin, avidin or streptavidin.