Kits for assays of rapid screening of diabetes

• US 7,429,462 B2
• Filed: 02/15/2007
• Issued: 09/30/2008
• Est. Priority Date: 11/20/2002
• Status: Expired due to Fees

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Lane, Jennifer Dawn, Carney, Fiona Patricia, Morris, Carol Ann
• Primary Examiner(s): Gitomer; Ralph
• Assistant Examiner(s): Wood; Amanda P
• Application Number:
  US11/706,809
• Publication Number:
  US 20070154395A1
• Time in Patent Office: 593 Days
• Field of Search: None
• US Class Current: 435/14
• 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. 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, wherein the 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, wherein the ophthalmic device comprises a glucose-sensing layer-by-layer coating which is not covalently attached to the core material of the ophthalmic device, and wherein the glucose-sensing layer-by-layer coating comprises one or more layers of a vesicle with a charged surface and with the receptor and the competitor entrapped therein.

2. A kit of claim 1, wherein the glucose-sensing layer-by-layer 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.

3. A kit of claim 2, 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.