Claims for Patent: 7,803,636

Summary for Patent: 7,803,636

Title:	Devices for analyte assays with built-in result reporting using recognizable symbols
Abstract:	The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.
Inventor(s):	Gao; Fei (Hangzhou, CN), Wu; Shujiang (Hangzhou, CN), Chen; Huikang (Hangzhou, CN), Xiong; DengFeng (Hangzhou, CN), Lin; Jinn-nan (San Diego, CA), McMenamy; James (San Diego, CA)
Assignee:	Alere Switzerland GmbH (Zug, CH)
Application Number:	11/936,742
Patent Claims:	1. A device for performing an assay to detect the presence or absence of an analyte in a sample comprising: a matrix that supports the flow of a liquid sample; an application zone on the matrix for receiving the liquid sample; one or more reagent zones on the matrix comprising reagents for conducting the assay; a detection zone on the matrix, the detection zone comprising an analyte binding area and a positive control area demarcated on the matrix; wherein the analyte binding area and the positive control area interact to form recognizable symbols indicative of the presence or absence of analyte in the sample, and wherein at least a portion of detection zone is covered by an opaque, water-soluble dye. 2. The device of claim 1 wherein the opaque, movable material covers only the positive control area. 3. The device of claim 1 wherein the analyte is selected from the group consisting of leutenizing hormone (LH), human chorionic gonadotropin (hCG), follicle stimulating hormone (FSH), hepatitis B surface antigen, human immunodeficiency virus (HIV), a bacteria-specific protein, creatinine, bilirubin, heavy metals, leukocytes, toxins, and a drug of abuse. 4. The device of claim 1 wherein the analyte is leutenizing hormone. 5. The device of claim 1 wherein the analyte is human chorionic gonadotropin. 6. The device of claim 1 wherein the positive control area comprises two areas situated at either side of the analyte binding area. 7. The device of claim 1 wherein the positive control area is in the form of a symbol, and wherein further the symbol comprises a color. 8. The device of claim 7, wherein the opaque, water-soluble dye comprises a color that is different from the color of the symbol of the positive control area. 9. A device for performing an assay to detect the presence or absence of an analyte in a sample comprising: a matrix that supports the flow of a liquid sample; an application zone on the matrix for receiving the liquid sample; one or more reagent zones on the matrix comprising reagents for conducting the assay; a detection zone on the matrix, the detection zone comprising an analyte binding area and a positive control area demarcated on the matrix; wherein the analyte binding area and the positive control area interact to form recognizable symbols indicative of the presence or absence of analyte in the sample, and wherein at least a portion of detection zone is covered by an opaque, movable material, wherein the opaque, movable material comprises beads. 10. The device of claim 9 wherein the beads cover only the positive control area. 11. The device of claim 10 wherein the positive control area is in the form of a symbol, and wherein further the symbol comprises a color. 12. The device of claim 11, wherein the beads comprise a color that is different from the color of the symbol of the positive control area. 13. The device of claim 9 wherein the analyte is selected from the group consisting of leutenizing hormone (LH), human chorionic gonadotropin (hCG), follicle stimulating hormone (FSH), hepatitis B surface antigen, human immunodeficiency virus (HIV), a bacteria-specific protein, creatinine, bilirubin, heavy metals, leukocytes, toxins, and a drug of abuse. 14. The device of claim 9 wherein the analyte is leutenizing hormone. 15. The device of claim 9 wherein the positive control area comprises two areas situated at either side of the analyte binding area. 16. The device of claim 9 wherein the analyte is human chorionic gonadotropin. 17. A kit comprising: a device for performing an assay to detect the presence or absence of an analyte in a sample comprising: a matrix that supports the flow of a liquid sample; an application zone on the matrix for receiving the liquid sample; one or more reagent zones on the matrix comprising reagents for conducting the assay; a detection zone on the matrix, the detection zone comprising an analyte binding area and a positive control area demarcated on the matrix; wherein the analyte binding area and the positive control area interact to form recognizable symbols indicative of the presence or absence of analyte in the sample, and wherein at least a portion of detection zone is covered by an opaque, water-soluble dye; and instructions for use of the device. 18. The kit of claim 17 wherein the analyte binding area comprises two areas situated on either side of the positive control area having a specific binding molecule for the analyte or for a molecule bound to the analyte, and the positive control area and analyte binding area interact to form a recognizable symbol when analyte is present in the sample. 19. The kit of claim 17 wherein the analyte is selected from the group consisting of leutenizing hormone (LH), human chorionic gonadotropin (hCG), follicle stimulating hormone (FSH), hepatitis B surface antigen, human immunodeficiency virus (HIV), a bacteria-specific protein, creatinine, bilirubin, heavy metals, leukocytes, toxins, and a drug of abuse. 20. The kit of claim 17 wherein the analyte is selected from the group consisting of: human chorionic gonadotropin and leutenizing hormone.

Details for Patent 7,803,636

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974		2027-11-07
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984		2027-11-07
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985		2027-11-07
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990		2027-11-07
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	March 26, 1974		2027-11-07
Fresenius Kabi Usa, Llc	CHORIONIC GONADOTROPIN	chorionic gonadotropin	For Injection	017067	March 05, 1973		2027-11-07