High glucose-determining analytical element

• US 4,427,770 A
• Filed: 06/14/1982
• Issued: 01/24/1984
• Est. Priority Date: 06/14/1982
• Status: Expired due to Term

• Current Assignee: Miles Laboratories Incorporated Elkhart Indiana
• Original Assignee: Miles Laboratories, Inc. (Bayer AG)
• Inventors: Warchal, Mary E., Chen, Shuenn-tzong, Sherwood, Mark J.
• Primary Examiner(s): Marantz, Sidney
• Application Number:
  US06/388,123
• Time in Patent Office: 589 Days
• Field of Search: 435/14, 435/28, 435/805, 422/56, 436/95
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/28 involving peroxidase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: C12Q 2326/50 Phenols; Naphthols; Catechols
• CPC Class Codes: C12Q 2326/96 4-Amino-antipyrine
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

An analytical element for quantitatively determining high levels of glucose in blood is made by (a) impregnating a carrier with a first solution, having dissolved therein 4-aminoantipyrine and 3-hydroxy-2,4,6-triiodobenzoic acid or 3,5-dichloro-2-hydroxy-benzene sulfonic acid or salts thereof, a glucose oxidase and a peroxidase, and drying the carrier; and (b) applying to the carrier a second solution of a film-forming agent in a volatile solvent, and drying to remove the volatile solvent and leave a film over the dried first impregnant.

Claims

1. A method for preparing an analytical element for determining glucose in a liquid sample which method comprises the steps of

(a) impregnating a carrier with a first solution having dissolved therein 4-aminoantipyrine or a salt thereof and 3-hydroxy-2,4,6-triiodobenzoic acid or 3,5-dichloro-2-hydroxy-benzene sulfonic acid, or a salt thereof, a glucose oxidase and a peroxidase, and drying the carrier;

and

(b) applying to the carrier a second solution of film-forming agent in a volatile solvent, and drying to remove the volatile solvent and leave a film over the dried first impregnant.

2. A method according to claim 1, wherein the concentration of the 4-aminoantipyrine or salt thereof in the first solution is from about 5 to 40 mmoles/liter.

3. A method according to claim 1, wherein the concentration of the 3-hydroxy-2,4,6-triiodobenzoic acid or 3,5-dichloro-2-hydroxybenzene sulfonic acid, or salt thereof, in the first solution is from about 0.5 to 500 mmoles/liter.

4. A method according to claim 1, wherein the film-forming agent in the second solution is a hydrophobic cellulose ether or ester.

5. A method according to claim 1, wherein the first solution contains a buffer for maintaining a pH from about 5 to 8 and a mordant.

6. A method according to claim 5, wherein the concentration of the 4-aminoantipyrine or salt thereof in the first solution is from about 10 to 30 mmoles/liter and the concentration of the 3,5-dichloro-2-hydroxybenzene sulfonic acid or salt thereof in the first solution is from about 1 to 50 mmoles/liter.

7. A method according to claim 5, wherein the concentration of the 4-aminoantipyrine or salt thereof in the first solution is about 15 mmoles/liter, the concentration of the 3,5-dichloro-2-hydroxybenzene sulfonic acid or salt thereof in the first solution is about 6 mmoles/liter, and the film-forming agent in the second solution is a hydrophobic cellulose ether or ester.

8. A method according to claim 5, wherein the 4-aminoantipyrine is present in the first solution as the hydrochloride, the sulfonic acid is present in the first solution as the sodium salt, the solvent in the first solution is water, the pH of the first solution is about 7 and it contains a polymeric polycarboxylic acid or anhydride thereof as the mordant, and the film-forming agent in the second solution is ethyl cellulose.

9. An analytical element for determining whole blood glucose produced by the process of claim 1.

10. A method for determining the glucose content of whole blood within the range of about 2000 to 8000 mg/liter comprising contacting the whole blood with an analytical element produced by the process of claim 1, and matching the resulting color of the element with predetermined standards.

11. A system for determining the glucose content of whole blood over a range from about 0 to 8000 mg/liter comprising, in combination, an element for identifying a glucose content of up to about 2000 mg/liter, and the analytical element produced by the process of claim 1.