Claims for Patent: 8,431,405

Summary for Patent: 8,431,405

Title:	Hyperglycosylated hCG detection device
Abstract:	The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.
Inventor(s):	Nazareth; Albert R. (Mercerville, NJ), Snowden; Timothy (Howell, NJ)
Assignee:	Church & Dwight Co., Inc. (Princeton, NJ)
Application Number:	13/591,370
Patent Claims:	1. A device for selectively detecting hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample deposited directly or indirectly on a proximal portion of the device for transport to a distal portion of the device, wherein the device comprises: A) a release medium formed of a first material and comprising: i) a labeled conjugate comprising a detectable label and a first binding member that is reactive with a first epitope of hCG-H; and ii) a capturable component comprising a second binding member reactive with a second epitope of hCG-H, at least one of the first binding member and the second binding member exhibiting a moderate to high affinity for the respective epitope of hCG-H and being selectively or preferentially reactive with the respective epitope of hCG-H, such that in the presence of hCG-H in the sample, a complex is formed comprising the labeled conjugate, hCG-H, and the capturable component; and B) a capture medium in fluid communication with the release medium and formed of a second, different material, the capture medium comprising a capture site having immobilized thereon a capture component having a binding affinity for the capturable component. 2. The device of claim 1, wherein the capturable component comprises a biotinylated capturable component and the capture component comprises streptavidin. 3. The device of claim 1, wherein only the first binding member exhibits a moderate to high affinity for the respective epitope of hCG-H and is selectively or preferentially reactive with the respective epitope of hCG-H. 4. The device of claim 1, wherein only the second binding member exhibits a moderate to high affinity for the respective epitope of hCG-H and is selectively or preferentially reactive with the respective epitope of hCG-H. 5. The device of claim 1, wherein both the first binding member and the second binding member exhibit a moderate to high affinity for hCG-H and are selectively or preferentially reactive with hCG-H.

Details for Patent 8,431,405

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	8,431,405	2032-08-22
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	8,431,405	2032-08-22
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	8,431,405	2032-08-22
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990	8,431,405	2032-08-22
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	March 26, 1974	8,431,405	2032-08-22