Nonenzymatic glucose test

• US 5,217,691 A
• Filed: 05/04/1992
• Issued: 06/08/1993
• Est. Priority Date: 11/19/1984
• Status: Expired due to Fees

• Current Assignee: Miles, Inc. (Bayer AG)
• Original Assignee: Miles, Inc. (Bayer AG)
• Inventors: Greene, Carmine, Wu, Wen H., Ismail, Ibrahim A.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): McMahon, Timothy M.
• Application Number:
  US07/878,224
• Time in Patent Office: 400 Days
• Field of Search: 422/55, 422/56, 422/57, 422/61, 436/95
• US Class Current: 422/424
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The invention provides a nonenzymatic method useful for the semiquantitative determination of glucose, a test composition and test device. Glucose concentration in an aqueous test sample can be determined by preparing a test solution by contacting an aqueous test sample and a dihydroxide component, at an initial pH above 6.5, capable of forming a complex with glucose which complex formation releases a proton, and determining the final pH of the test solution. The invention also provides a self-indicating device format which allows the determination of glucose concentration by merely counting the number of pads which have changed color. No comparison to a color chart is required. The glucose test of the present invention is free of the interferences found in enzymatic glucose tests.

Claims

1. A reagent test strip for the semiquantitative determination of glucose consisting essentially of:

a paper matrix impregnated with a test composition wherein the test composition contains from 0.1 to 0.3 M of a borate dihydroxide component selected from the group consisting of boric acid, phenylboronic acid, p-nitrophenylboronic acid, 4-methoxyphenylboronic acid, α

-naphthylboronic acid and naphthylboronic acid titrated to an initial pH above 6.5 prior to incorporation with a pH indicator capable of providing a colorimetric response in the pH range of 6.5 to 12, said indicator being selected from the group consisting of m-cresol purple, cresol red, neutral red, thymol blue, phenolphthalein, o-cresol phthalein, phenol red and bromothymol blue.

2. A self-indicating test device useful for the visual semiquantitative determination of glucose concentration in an aqueous test sample, said test device consisting essentially of:

first and second paper matrices separately affixed to a support member wherein the first matrix is incorporated with a first reagent system and the second matrix is incorporated with a second reagent system,

wherein each of said reagent systems is formed by impregnating the respective paper matrices with from 0.1 to 0.3 M of a borate dihydroxide component selected from the group consisting of boric acid, phenylboronic acid, ρ

-nitrophenylboronic acid, 4-methoxyphenylboronic acid, α

-naphthylboronic acid and naphthylboronic acid titrated to an initial pH above 6.5 prior to incorporation with a pH indicator capable of providing colorimetric response in the pH range of 6.5 to 12, said indicator being selected from the group consisting of m-cresol purple, cresol red, neutral red, thymol blue, phenolphthalein, o-cresol phthalein, phenol red and bromothymol blue; and

wherein the first and second reagent systems are different such that the threshold pH which causes a response to glucose with respect to the first reagent system is different from the threshold pH which causes a response to glucose with respect to the second reagent system.

3. The self-indicating test device of claim 2 wherein the indicator is a dual indicator comprising bromothymol blue and cresol red.