IP Library Granted Patent US 7,439,033
Granted Patent B2
US 7,439,033 · App. 10/767,963 · Granted Oct 21, 2008

Method and test strip for determining a fluid analyte

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Quick Facts
Patent No.
US 7,439,033
App. No.
10/767,963
Granted
Oct 21, 2008
Kind
B2
Abstract

A reagent strip for measuring the concentration of glucose in whole blood has a polymer on at least one side thereof to increase the opacity thereof, thereby reducing the effect of hematocrit on the glucose determination.

Claims (28)

1. A method for determining analyte concentration in a fluid sample, the method comprising the acts of:

(a) providing a test strip having a sample side and a reaction side, the test strip including a porous membrane, the test strip being adapted to accept a sample on the sample side and pass it towards the reaction side, said test strip including a testing reagent, said testing reagent comprising a color indicator system that changes color to indicate the presence of the analyte in the sample, said test strip further having a polymer on at least the reaction side, said polymer increasing the opacity of at least a portion of the test strip after contact with a sample, said polymer being selected from the group consisting of acrylic latex polymers, polystyrene sodium sulfate polymers, and combinations thereof;

(b) applying the sample to the sample side of the test strip; and

(c) measuring the change in color of the testing side to determine the analyte concentration of the sample.

2. The method of claim 1 wherein the analyte is glucose.

3. The method of claim 1 wherein said porous membrane includes polyethersulfones, modified polyethersulfones, or combinations thereof.

4. The method of claim 1 wherein the testing reagent comprises a chemistry system selected from the group consisting of a PQQ-GDH system, a NAD-dependent GDH system, a hexokinase reductive system, and a glucose oxidase oxidative system.

5. The method of claim 1 wherein the indicator system includes tetrazolium compounds or tetrazolium salt compounds.

6. The method of claim 5 wherein the indicator system comprises a 2-thiazolyl tetrazolium salt compound.

7. The method of claim 1 wherein the reagent comprises a mediator compound including a substituted or unsubstituted 3-phenylimino-3H-phenothiazine or 3-phenylimino-3H-phenoxazine.

8. The method of claim 1 wherein said test strip has pore sizes in the range of about 0.2 microns to about 5 microns.

9. The method of claim 8 wherein said test strip is isotropic.

10. The method of claim 8 wherein said test strip is anisotropic.

11. A test strip for measuring an analyte concentration in a fluid sample, the test strip comprising:

(a) a porous membrane having a sample side and a reaction side, the membrane being adapted to accept the sample on the sample side and pass it towards the reaction side;

(b) a testing reagent supported by the membrane, said testing reagent comprising a color indicator system that changes color to indicate the presence of analyte in the sample; and

(c) a polymer on at least a portion of the reaction side of the porous membrane, said polymer increasing the opacity of at least a portion of the test strip after contact with the sample, said polymer being selected from the group consisting of acrylic latex polymers, polystyrene sodium sulfate polymers, and combinations thereof.

12. The test strip of claim 11 wherein the analyte is glucose.

13. The test strip of claim 11 wherein said porous membrane includes polyethersulfones, modified polyethersulfones, or combinations thereof.

14. The test strip of claim 11 wherein the testing reagent comprises a chemistry system selected from the group consisting of a PQQ-GDH system, a NAD-dependent GDH system, a hexokinase reductive system, and a glucose oxidase oxidative system.

15. The test strip of claim 11 wherein the indicator system includes tetrazolium compounds or tetrazolium salt compounds.

16. The test strip of claim 15 wherein the indicator system comprises a 2-thiazolyl tetrazolium salt compound.

17. The test strip of claim 11 wherein the reagent comprises a mediator including a substituted or unsubstituted 3-phenylimino-3H-phenothiazine or 3-phenylimino-3H-phenoxazine.

18. The test strip of claim 11 wherein said test strip has pore sizes in the range of about 0.2 microns to about 5 microns.

19. The test strip of claim 18 wherein said test strip is isotropic.

20. The test strip of claim 18 wherein said test strip is anisotropic.

21. The test strip of claim 18 wherein said testing reagent includes a glucose dehydrogenase (GDH) system.

22. The method of claim 1 wherein said testing reagent includes a glucose dehydrogenase (GDH) system.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2016
From: BAYER HEALTHCARE LLC
To: ASCENSIA DIABETES CARE HOLDINGS AG
Reel/Frame 037880/0604 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY ADDRESS PREVIOUSLY RECORDED AT REEL: 021300 FRAME: 0622. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Dec 20, 2015
From: MARFURT, KAREN L.
To: BAYER HEALTHCARE LLC
Reel/Frame 037337/0840 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2008
From: MARFURT, KAREN L.
To: BAYER HEALTHCARE LLC
Reel/Frame 021300/0622 →