Claims for Patent: 8,227,197

Summary for Patent: 8,227,197

Title:	Methods and kits for detecting ITA in a biological sample
Abstract:	Methods for detecting invasive trophoblast antigen (ITA) in biological samples comprise screening the samples for ITA using antibodies that bind to the ITA. The methods are useful to detect pregnancy, trophoblastic diseases, and Down\'s syndrome in fetuses of pregnant women. Some methods include screening the samples with a plurality of capture antibodies that specifically bind ITA. Chemiluminescent immunoassays are disclosed. The methods may be practiced with the diagnostic kits of the invention.
Inventor(s):	Pandian; Murugan R. (Mission Viejo, CA), Yu; Julie Y. (Mission Viejo, CA)
Assignee:	Quest Diagnostics Investments Incorporated (Wilmington, DE)
Application Number:	13/018,182
Patent Claims:	1. A method for assessing the glycosylation status of human chorionic gonadotropin (hCG) in a pregnant woman comprising: (i) contacting a biological sample from the pregnant woman in a combination assay comprising a first capture antibody that specifically binds the same invasive trophoblast antigen (ITA) epitope that is bound by antibody B152, a second capture antibody that specifically binds the same hCG epitope that is bound by antibody 827, and a detection antibody that binds the same epitope on hCG and ITA that is bound by antibody B207, the detection antibody comprising a detectable label, wherein the first and second capture antibodies and the detection antibody bind to different epitopes; (ii) detecting the detectable label; and (iii) comparing the total ITA and hCG signal generated in the sample to the signal generated from a population of pregnant women carrying normal fetuses, wherein an elevated signal in the sample relative to the signal from the population of women carrying normal fetuses indicates an increased glycosylation of hCG in the pregnant woman. 2. The method of claim 1, wherein the biological sample is selected from the group consisting of serum, plasma, and urine. 3. The method of claim 1, wherein the detectable label is selected from the group consisting of a fluorescent label, a radioactive label, and a chemiluminescent label. 4. The method of claim 1, wherein the detectable label is an acridinium ester. 5. A method for assessing the glycosylation status of human chorionic gonadotropin (hCG) in a pregnant woman comprising: (i) contacting a biological sample from the pregnant woman in a combination assay comprising a first capture antibody that specifically binds the same invasive trophoblast antigen (ITA) epitope that is bound by antibody B152, a second capture antibody that specifically binds the same hCG epitope that is bound by antibody 820, and a detection antibody that binds the same epitope on hCG and ITA that is bound by antibody B207, the detection antibody comprising a detectable label, wherein the first and second capture antibodies and the detection antibody bind to different epitopes; (ii) detecting the detectable label; and (iii) comparing the total ITA and hCG signal generated in the sample to the signal generated from a population of pregnant women carrying normal fetuses, wherein an elevated signal in the sample relative to the signal from the population of women carrying normal fetuses indicates an increased glycosylation of hCG in the pregnant woman. 6. The method of claim 5, wherein the biological sample is selected from the group consisting of serum, plasma, and urine. 7. The method of claim 5, wherein the detectable label is selected from the group consisting of a fluorescent label, a radioactive label, and a chemiluminescent label. 8. The method of claim 5, wherein the detectable label is an acridinium ester.

Details for Patent 8,227,197

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	8,227,197	2031-01-31
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	8,227,197	2031-01-31
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	8,227,197	2031-01-31