Inventors:
Laurence A. Cole - Albuquerque NM
Andrew Kardana - New Haven CT
Assignee:
Yale University - New Haven CT
International Classification:
G01N 3349
US Classification:
436 87, 436 86, 436501, 436510, 436518, 436817, 436570, 436536, 436547, 436548, 436808, 436813, 436814, 436818, 437 71, 437 721, 437 79, 437 792, 437 793, 437 794, 437 795, 437806, 424 11, 424100
Abstract:
A prenatal screening method for Downs 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 -subunit, -core fragment, and/or free -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 Downs syndrome, indicates that the womans fetus has Downs syndrome. Typical screens involve carbohydrate analyses, immunoassays, or combinations of these methods. Some embodiments employ a lectin such as concanavalin A reactive to the carbohydrate moiety; others employ antibodies to at least one hyperglycosylated gonadotropin species.