Methods and kits for assays of rapid screening of diabetes

• US 20070154395A1
• Filed: 02/15/2007
• Published: 07/05/2007
• Est. Priority Date: 11/20/2002
• Status: Active Grant

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Morris, Carol, Lane, Jennifer, Carney, Fiona
• Granted Patent: US 7,429,462 B2
• Time in Patent Office: Days
• US Class Current: 424/9.600
• CPC Class Codes: G01N 2800/042 Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

The invention provides an in vivo screening assay and an in vitro screening assay for rapid screening of diabetes. A method of the invention includes determining a first glucose concentration in an ocular fluid of a patient; administering orally a load of carbohydrate to the patient; determining a second glucose concentration in an ocular fluid of the patient at a period of time of less than 50 minutes after orally administering of the load of carbohydrate; comparing the second glucose concentration with the first glucose concentration to determine if the patient is likely to be a diabetic. The method of the invention is performed by using a kit of the invention. The kit comprises: (1) a glucose-sensing ophthalmic device and instructions for using the glucose-sensing ophthalmic device to screen for diabetes; or (2) two or more tear-collecting devices, and a testing agent composition which specifically reacts with glucose to form a detectable signal. The glucose-sensing ophthalmic device comprises a testing agent composition which specifically and reversibly interacts with glucose to form a detectable optical signal which changes in a concentration-dependent manner.

Claims

1-11. -11. (canceled)

12. A kit for rapid screening of diabetes, the kit comprising:

a glucose-sensing ophthalmic device and instructions for using the glucose-sensing ophthalmic device to screen for diabetes, wherein the glucose-sensing ophthalmic device comprises a testing agent composition which specifically and reversibly interacts with glucose to form a detectable optical signal which changes in a concentration-dependent manner.

13. A kit of claim 12, wherein said testing agent composition comprises a receptor that is capable of reversibly binding glucose and has a detectable optical signal that changes in a concentration-dependent manner when the receptor is reversibly bound to glucose, wherein said detectable optical signal results from one or more labels associated with the receptor.

14. A kit of claim 13, wherein the detectable optical signal results from a pair of labels associated with the receptor, a first label and a second label, wherein one of the first and second label is a fluorescence energy donor and the other is a fluorescence energy acceptor or a non-fluorescence energy acceptor.

15. A kit of claim 14, wherein said receptor is selected from the group consisting of GGBP, concanavalin A, inactivated glucose oxidase, inactivated glucose dehydrogenase, and boronic acid.

16. A kit of claim 14, wherein said fluorescent energy donor is selected from the group consisting of xanthene-type dyes, fluorescein-type dyes, rhodamine-type dyes, cyanine-type dyes, phycobiliproteins.

17. A kit of claim 12, wherein said testing agent composition comprises a receptor having a first label associated therewith and a competitor having a second label associated therewith, wherein one of the first and second labels is a fluorescent energy donor and the other one is a fluorescent or non-fluorescent energy acceptor.

18. A kit of claim 12, wherein the ophthalmic device can comprise a glucose-sensing LbL coating which is not covalently attached to the core material of the ophthalmic device, wherein the glucose-sensing LbL coating comprises the testing agent composition.

19. A kit of claim 18, wherein the glucose-sensing LbL coating comprises one or more layers of a vesicle with a charged surface and with a receptor or a competitor entrapped therein, wherein the receptor has a first label associated therewith and the competitor has a second label associated therewith, wherein one of the first and second labels is a fluorescent energy donor and the other one is a fluorescent or non-fluorescent energy acceptor.

20. A kit of claim 18, wherein the glucose-sensing LbL coating comprises one or more layers of a vesicle with a charged surface and with a receptor entrapped therein, wherein the receptor is capable of reversibly binding glucose and has a detectable optical signal that changes in a concentration-dependent manner when the receptor is reversibly bound to glucose, wherein said detectable optical signal results from one or more labels associated with the receptor.

21. A kit of claim 20, wherein the detectable optical signal results from a pair of labels associated with the receptor, a first label and a second label, wherein one of the first and second label is a fluorescence energy donor and the other is a fluorescence energy acceptor or a non-fluorescence energy acceptor.

22. A kit for rapid screening of diabetes, the kit comprising:

two or more tear-collecting devices, and a testing agent composition which specifically reacts with glucose to form a detectable signal.

23. A kit of claim 22, wherein said two or more tear-collecting devices are selected from the group consisting of a hydrogel strip, a capillary tube, and a soft-hydrogel contact lens.

24. A kit of claim 23, wherein said two or more tear-collecting devices are hydrogel strips, wherein each of said strips has a first end and an opposite second end, wherein each of said strips is made of a hydrogel material in substantially dry state and is characterized by having a substantially uniform swelling along that hydrogel strip from the first end to the second end when fully wicked by a tear fluid and by having a correlation between the volume of tear uptake by that strip and the length of a tear-wicked end portion of that strip.

25. A kit of claim 24, wherein said hydrogel material is selected from the group consisting of poly(vinyl alcohol), modified polyvinylalcohol, poly(hydroxyethyl methacrylate), poly(vinyl pyrrolidone), poly(vinyl alcohol) with polycarboxylic acids, polyethylene glycol, polyacrylamide, polymethacrylamide, silicone-containing hydrogels, polyurethane, polyurea, and mixtures thereof.

26. A kit of claim 24, wherein said defined correlation between the volume of tear uptake and the length of the tear-wicked end portion is a substantially linear relationship.

27. A kit of claim 24, wherein each of said strips has noticeable marks thereon, wherein each of the marks indicates a volume of the tear fluid absorbed by the end portion up to that mark of that strip.

28. A kit of claim 22, wherein said testing agent composition comprises a receptor that is capable of reversibly binding glucose and has a detectable optical signal that changes in a concentration-dependent manner when the receptor is reversibly bound to glucose, wherein said detectable optical signal results from one or more labels associated with the receptor.

29. A kit of claim 28, wherein said testing agent composition comprises a receptor that is capable of reversibly binding glucose and has a detectable optical signal that changes in a concentration-dependent manner when the receptor is reversibly bound to glucose, wherein said detectable optical signal results from a pair of labels, a first label and a second label, associated with the receptor, wherein one of the first and second label is a fluorescence energy donor and the other is a fluorescence energy acceptor or a non-fluorescence energy acceptor.

30. A kit of claim 22, wherein said testing agent composition comprises a receptor having a first label associated therewith and a competitor having a second label associated therewith, wherein one of the first and second labels is a fluorescent energy donor and the other one is a fluorescent or non-fluorescent energy acceptor.