- Patent Number:
7,008,775
- Appl. No:
10/291992
- Application Filed:
November 12, 2002
- نبذة مختصرة :
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.
- Inventors:
Martens, Mark G. (Jenks, OK, US); Kaul, Anil K. (Plymouth, MN, US); Kaul, Rashmi (Plymouth, MN, US)
- Claim:
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.
- Claim:
2. The method of claim 1 , wherein the anti-CD55 antibody is immobilized on a solid surface.
- Claim:
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.
- Claim:
4. The method of claim 3 wherein the detectable label is an enzyme label.
- Claim:
5. The method of claim 4 wherein the detectable label is a fluorogenic compound.
- Claim:
6. The method of claim 3 wherein the binding site for the detectable label is biotin, avidin or streptavidin.
- Claim:
7. The method of claim 3 wherein the levels of the complexes have an optical density (OD) level below 14.
- Claim:
8. The method of claim 7 wherein the OD level is below 10.
- Claim:
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.
- Claim:
10. The method of claim 9 wherein the detectable label is an enzyme label.
- Claim:
11. The method of claim 9 wherein the detectable label is a fluorogenic compound.
- Claim:
12. The method of claim 9 wherein the binding site for the detectable label is biotin, avidin or streptavidin.
- Current U.S. Class:
435/71
- Patent References Cited:
5376531 December 1994 Anderson et al.
200002703 June 1998
- Other References:
Cunningham et al. Clinical Immunology and Immunopathology 1995 74: 156-161. cited by examiner
Bjorge, L..,et al. ,“Soluble CD59 in Pregancy and Infancy”, Immunology Letters, 36, Letter to the Editor,(1993),p. 233. cited by other
Holmes, C..H. ,et al. ,“Complement and Pregancy: New Insights into the Immunobiology of the Fetomaternal Relationship”, Baillieres's Clinical Obstetrics and Gynecology, 6, (1992),439-460. cited by other
Holmes, C..H. ,et al. ,“Complement Regulatory Proteins at the Feto-maternal Interface During Human Placental Development: Distribution of CD59 by Comparison with Membrane Cofactor Protein (CD46) and Decay Accelerating Factor (CD55)”, Eur. J. Immunology, 22, (1992), 1579-1585. cited by other
Imrie, H..J. ,et al. ,“Reduction in Erythrocyte Complement Receptor 1 (CR1, CD35) and Decay Accelerating Factor (DAF, CD55) During Normal Pregnancy”, Journal of Reproductive Immunology, 31, (1996),221-227. cited by other
McLaughlin, P..J. ,et al. ,“Soluble CD46 (Membrane Cofactor Protein, MCP) in Human Reproductive Tract Fluids”, Journal of Reproductive Immunology, 31, (1996),209-219. cited by other
Morgan, B..P. ,“Physiology and Pathophysiology of Complement: Progress and Trends”, Critical Reviews in Clinical Laboratory Sciences, 32, (1995),265-298. cited by other
Vanderpuye, O..A. ,et al. ,“Characterization of Cofactor Activity for Factor I: Cleavage of Complement C4 in Human Syncytiotrophoblast Microvilli”, Placenta, 15, (1994), 157-170. cited by other
- Assistant Examiner:
Cheu, Jacob J.
- Primary Examiner:
Le, Long V.
- Attorney, Agent or Firm:
Schwegman, Lundberg, Woessner & Kluth, P.A.
- الرقم المعرف:
edspgr.07008775
Processing Request
No Comments.