Methods for predicting pregnancy outcome in a subject by hcg assay

Abstract

The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

1 - 66 . (canceled) 
     
     
         67 . A diagnostic kit for determining amount of nicked human chorionic gonadotropin (hCG) in a sample comprising:
 (a) a capturing antibody which specifically or preferentially binds to nicked (hCG), wherein the capturing antibody is B151; and   (b) reagents permitting the formation of a complex between the capturing antibody and nicked hCG in the sample.   
     
     
         68 . The diagnostic kit of  claim 67 , further comprising a detection antibody. 
     
     
         69 . The diagnostic kit of  claim 68 , wherein the detection antibody is labeled with a detectable marker. 
     
     
         70 . The diagnostic kit of  claim 69 , wherein the detectable marker is a radioactive isotope, enzyme, dye, magnetic bead, or biotin. 
     
     
         71 . The diagnostic kit of  claim 70 , wherein the radioactive isotope is I 125 . 
     
     
         72 . The diagnostic kit of  claim 68 , wherein the detection antibody is B604. 
     
     
         73 . The diagnostic kit of  claim 68 , wherein the detection antibody is B207. 
     
     
         74 . The diagnostic kit of  claim 68 , wherein the sample is a urine sample. 
     
     
         75 . The diagnostic kit of  claim 68 , wherein the sample is a blood sample.