Blood glucose strip having reduced sensitivity to hematocrit

• US 5,789,255 A
• Filed: 07/29/1997
• Issued: 08/04/1998
• Est. Priority Date: 10/17/1995
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Yu, Yeung S.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/902,581
• Time in Patent Office: 371 Days
• Field of Search: 422/56, 422/58, 422/61, 436/95
• US Class Current: 436/95
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• 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: Y10T 436/144444 Glucose

Abstract

A reagent strip for measuring glucose concentration in whole blood has reduced interference of hematocrit with the glucose measurement. When a biological fluid contacts the strip, it causes, in a reagent impregnated in the strip, a color change that is a measure of the glucose concentration in the fluid. However, the color change is also affected by the red blood cell concentration (hematocrit), thereby reducing the accuracy of the glucose measurement. The hematocrit effect is reduced by adding to the reagent an acrylic acid polymer.

Claims

1. A reagent strip for measuring glucose concentration in a sample of whole blood that contains red cells, comprising:

(a) an anisotropic membrane having a sample side with relatively large pores and a testing side with relatively smaller pores, the membrane being adapted to accept the sample on the sample side and pass it toward the testing side; and

(b) a testing reagent impregnated in the membrane, the testing reagent comprising

(i) a component for creating hydrogen peroxide from glucose and oxygen,

(ii) an indicator for reacting with the hydrogen peroxide to cause a change in the color of the indicator, and

(iii) an acrylic acid polymer, of molecular weight at least about 750,000, whose concentration is in a range from about 0.1% to about 2% w/v,

whereby any effect of the red blood cells on the glucose concentration measurement is reduced by the acrylic acid polymer.

2. The reagent strip of claim 1 further comprising a thermoplastic support for the membrane.

3. The reagent strip of claim 1 wherein the component for creating hydrogen peroxide from glucose and oxygen comprises glucose oxidase.

4. The reagent strip of claim 1 wherein the indicator comprises a peroxidase and a composition selected from the group consisting of (a) 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) combined with 3-dimethylaminobenzoic acid (DMAB);

(b) combined with 3,5-dichloro-2-hydroxybenzene-sulfonic acid (DCHBS); and

(c) 3-methyl-2-benzothiazolinone hydrazone! N-sulfonyl benzenesulfonate monosodium (MBTHSB) combined with 8-anilino-1-naphthalene sulfonic acid ammonium (ANS).

5. The reagent strip of claim 4 wherein the indicator comprises a peroxidase and MBTHSB-ANS.

6. The reagent strip of claim 1 wherein the molecular weight of the acrylic acid polymer is in the range from about 750,000 to about 4,000,000.

7. The reagent strip of claim 1 wherein the molecular weight of the acrylic acid polymer is about 750,000.

8. The reagent strip of claim 1 wherein the concentration of acrylic acid polymer is about 0.5% w/v.

9. The reagent strip of claim 1 further comprising a porous transport layer attached to the sample side of the membrane for accepting the sample and passing a detectable portion of it to the sample side of the membrane.

10. The reagent strip of claim 1 wherein the testing reagent further comprises an inhibitor to inhibit the change in color of the indicator.

11. A method for measuring glucose concentration in a sample of whole blood that contains red blood cells, which comprises the steps of:

(a) providing an anisotropic membrane, which

(i) has a sample side having relatively large pores and a testing side having relatively smaller pores and

(ii) is impregnated with a testing reagent that can react with glucose to cause a change in color of the testing side, the reagent comprising glucose oxidase, a peroxidase, an oxidizable dye or dye couple, and an acrylic acid polymer, of molecular weight at least about 750,000, whose concentration is in a range from about 0.1% to about 2% w/v;

(b) applying the blood to the sample side of the membrane; and

(c) measuring the change in color of the testing side to determine the glucose concentration in the blood.

12. The method of claim 11 wherein the glucose concentration in the blood is in the range from about 50 to about 400 mg/dL.

13. The method of claim 11 wherein the blood has a hematocrit level in the range from about 25% to about 60%.