Abstract: A prenatal screening method for Down's syndrome involves assaying for hyperglycosylated gonadotropin in biological test samples such as urine, plasma or serum obtained from pregnant women. Hyperglycosylated gonadotropin comprises a variant population of chorionic gonadotropin, chorionic gonadotropin-free &bgr;-subunit, &bgr;-core fragment, and/or free &agr;-subunit exhibiting differences in the carbohydrate content from what is observed in samples obtained from pregnant women carrying normal fetuses. Qualitative or quantitative observation of differences in the carbohydrate content of the hyperglycosylated gonadotropin population from corresponding control samples containing a normal gonadotropin population, or direct observation of the variant species seen in Down's syndrome, indicates that the woman's fetus has Down's syndrome. Typical screens involve carbohydrate analyses, immunoassays, or combinations of these methods.

Abstract: A substantially pure human chorionic gonadotropin beta subunit nicking enzyme (GBNE) has been purified from human blood serum. GBNE nicks the beta-subunit of human chorioinic gonadotropin at either Arg-44 or Gly-47, is an arginine specific metalloprotease, has an apparent molecular weight of between 150,000 and 430,000 daltons, and is partially inhibited by phenanthroline or leupeptin.