METHODS FOR PREDICTING PREGNANCY OUTCOME IN A SUBJECT BY hCG ASSAY

A method for detecting a pregnancy disorder in which hCG levels are abnormal in a pregnant subject comprising:

• (a) contacting a first portion of a sample from the subject with a first capturing antibody which specifically binds to an early pregnancy associated molecular isoform of hCG, which isoform is recognized by the antibody produced by hybridoma cell line B152 (ATCC Designation No. HB-12467), so as to bind the first capturing antibody to the early pregnancy associated molecular isoform of hCG present in the sample, thereby forming a first complex;
• (b) measuring the amount of complexes formed in step (a), thereby determining the amount of the early pregnancy associated molecular isoform of hCG in the sample;
• (c) contacting a second portion of the sample with a second capturing antibody which specifically binds to intact non-nicked hCG, which isoform is recognized by the antibody produced by hybridoma cell line B109 (ATCC Designation No. PTA-1624), so as to bind the second capturing antibody to the intact non-nicked hCG present in the sample, thereby forming a second complex;
• (d) measuring the amount of complexes formed in step (c), thereby determining the amount of intact non-nicked hCG in the sample;
• (e) comparing the amount measured in step (b) with the amount measured in (d) so as to thereby determine a ratio of the amount determined in step (b) to the amount determined in step (d);
• (f) repeating steps (a) through (e) so as to determine a pattern of the ratios measured;
• and
• (g) comparing the pattern of ratios determined in step (f) with that of a normal pregnant subject, wherein a pattern of abnormal ratios determined in step (f) compared with that of the normal pregnant subject indicates detection of a pregnancy disorder in which hCG levels are abnormal.

A method for detecting Down's syndrome in the fetus of a pregnant subject comprising:

• (a) contacting a sample from the subject with a capturing antibody which specifically or preferentially binds to nicked hCG, under conditions permitting formation of a complex between the capturing antibody and the nicked hCG;
• (b) determining the amount of complexes formed in step (a) thereby determining the amount of nicked hCG in the sample;
• and
• (c) comparing the amount of nicked hCG in the sample determined in step (b) with the amount determined for a normal pregnant subject, wherein the elevated level of nicked hCG in the sample as compared to that in the normal pregnant subject is indicative of Down's syndrome in the fetus.