Patent ID: 7871762
Filing Date: 2011-01-18
Classification: G01N

Abstract:
1. A method of detecting the presence or absence of invasive trophoblast cells in a patient risk for gestational trophoblastic disease or having a germ cell tumor comprising the steps of: a. obtaining a urine, saliva, serum or plasma sample from said patient; b. determining the amount of hCG in the sample wherein the amount of hCG comprises the total amount of intact hCG and ITA in the sample or comprises the total amount of intact hCG plus the amount of free β subunit of hCG and ITA in the sample; c. determining the total amount of ITA in the sample in an immunoassay which determines the selective binding of monoclonal B152 to ITA; d. determining the percentage of the amount of hCG determined in step b that is ITA, and e. determining that invasive trophoblast calls are present in the patient if the percentage of the amount of HCG that is ITA determined in step d is 30% or greater such that a diagnosis of gestational trophoblastic disease or the existence of a germ cell tumor may be made, wherein the amount of hCG comprises the total amount of intact hCG and ITA, plus the amount of free β sub unit of hCG in the sample.