Test strip for blood glucose testing

• US 5,556,761 A
• Filed: 04/26/1994
• Issued: 09/17/1996
• Est. Priority Date: 04/26/1994
• Status: Expired due to Fees

• Current Assignee: ABP Diagnostics, Ltd.
• Original Assignee: Clinical Diagnostics, Inc.
• Inventors: Phillips, Kevin J.
• Primary Examiner(s): Weimar, Elizabeth C.
• Assistant Examiner(s): Mohamed, Abdel A.
• Application Number:
  US08/233,376
• Time in Patent Office: 875 Days
• Field of Search: 435/14, 435/4, 435/970, 436/14, 422/55, 422/57, 422/82.05, 422/85, 422/87
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control

Abstract

A test strip for determining blood glucose levels comprising a reagent which incorporates a dye color. Whole blood reacts with the reagent of the test strip resulting in a color change on the reagent portion of the strip which is controlled by the dye color, indicating the blood glucose level by visual comparison with a color chart, or by the use a photometer. The use of a copolymer in the reagent which provides complete coalescence and a resulting smooth surface particle structure provides accurate readings of the reacted test strip by the photometer.

Claims

1. A test strip for use with a photometer for determining blood glucose levels, comprising a substrate having a red colored reagent thereon, wherein the reagent comprises at least one enzyme, at least one chromophore, and at least one red dye additive.

2. A test strip for use with a photometer for determining blood glucose levels as described in claim 1, wherein said chromophore is tetramethyl benzidine.

3. A test strip for use with a photometer for determining blood glucose levels as described in claim 1, wherein said red dye additive comprises Food Dye and Coloring Red Number 40, Food Dye and Coloring Red Number 3, and Food Dye and Coloring Blue Number 1.

4. A test strip for use with a photometer for determining blood glucose levels as described in claim 3, wherein said chromophore is tetramethyl benzidine.

5. A test strip for use with a photometer for determining blood glucose levels as described in claim 1, wherein said reagent further comprises a copolymer.

6. A test strip for use with a photometer for determining blood glucose levels as described in claim 5, wherein said chromophore is tetramethyl benzidine.

7. A test strip for use with a photometer for determining blood glucose levels as described in claim 5, wherein said red dye additive comprises Food Dye and Coloring Red Number 40, Food Dye and Coloring Red Number 3, and Food Dye and Coloring Blue Number 1.

8. A test strip for use with a photometer for determining blood glucose levels as described in claim 7, wherein said chromophore is tetramethyl benzidine.

9. A test strip for use with a photometer for determining blood glucose levels as described in claim 5, wherein said copolymer is a vinyl acetate ethylene copolymer.

10. A test strip for use with a photometer for determining blood glucose levels as described in claim 9, wherein said copolymer achieves complete coalescence.

11. A test strip for use with a photometer for determining blood glucose levels as described in claim 9, wherein said red dye additive comprises Food Dye and Coloring Red Number 40, Food Dye and Coloring Red Number 3, and Food Dye and Coloring Blue Number 1.

12. A test strip for use with a photometer for determining blood glucose levels as described in claim 10, wherein said red dye additive comprises Food Dye and Coloring Red Number 40, Food Dye and Coloring Red Number 3, and Food Dye and Coloring Blue Number 1.

13. A test strip for use with a photometer for determining blood glucose levels comprising a substrate having a red colored reagent coated thereon, wherein the reagent is a polymeric matrix comprising polymer resin, vinyl acetate ethylene copolymer, at least one enzyme, at least one chromophore, and at least one red dye additive.

14. A test strip for use with a photometer for determining blood glucose levels as described in claim 13, wherein said chromophore is tetramethyl benzidine.

15. A test strip for use with a photometer for determining blood glucose levels as described in claim 13, wherein said red dye additive comprises Food Dye and Coloring Red Number 40, Food Dye and Coloring Red Number 3, and Food Dye and Coloring Blue Number 1.

16. A test strip for use with a photometer for determining blood glucose levels as described in claim 15, wherein said red dye additive further comprises water, propylene glycol, and propyl paraben.

17. A test strip for use with a photometer for determining blood glucose levels as described in claim 15, wherein said chromophore is tetramethyl benzidine.

18. A test strip for use with a photometer for determining blood glucose levels as described in claim 15, wherein said copolymer achieves complete coalescence.

19. A test strip for use with a photometer for determining blood glucose levels as described in claim 18, wherein said red dye additive further comprises water, propylene glycol, and propyl paraben.