Test element with a one layer reaction film

• US 7,629,175 B2
• Filed: 02/18/2005
• Issued: 12/08/2009
• Est. Priority Date: 02/18/2004
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Mosoiu, Dan, Wittmann, Franz, Hoenes, Joachim, Horn, Carina, Knappe, Wolfgang-Reinhold
• Primary Examiner(s): Wallenhorst; Maureen M
• Application Number:
  US11/060,956
• Publication Number:
  US 20060003397A1
• Time in Patent Office: 1,754 Days
• Field of Search: 436/63, 436/95, 436/164, 436/165, 436/169, 422/55, 422/56, 422/58, 422/82.05, 422/82.08, 422/82.09, 435/14, 435/287.1
• US Class Current: 436/165
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The invention concerns test elements and methods for the optical detection of an analyte in a sample. The test element includes a support having at least one transparent portion, and a one-layer film positioned on the support. The film has a thickness when dry of less than about 10 μm. The method includes contacting the sample with the test element and determining the analyte concentration in the sample.

Claims

1. A test element for the optical detection of an analyte comprising:

a support having at least one transparent portion, and

a one-layer film positioned on the support, the film comprising a reagent for the reflection photometric detection of the analyte and pigment particles, the film having a thickness when dry about 10 μ

m or less, wherein the test element comprises only one functional layer, and wherein the film comprises a mixture of fine-grained pigment particles having an average diameter of less than 0.5 μ

m with medium and/or coarse-grained particles, the average diameter of medium grain particles being between about 0.7 μ

m and about 4 μ

m and the average diameter of coarse-grained particles being between about 4 μ

m and about 8 μ

m.

2. The test element of claim 1 wherein the thickness of the film when dry is about 2 μ

m to about 10 μ

m.

3. The test element of claim 1 wherein the reagent comprises at least one enzyme and at least one enzyme substrate that can be detected after an enzymatic reaction with the analyte.

4. The test element of claim 1 wherein a concentration of the reagent in the film is such that the test element supports a generally uniform reaction with the analyte over the thickness of the test element.

5. The test element of claim 1 wherein the film is porous.

6. The test element of claim 5 wherein the pore size is such that penetration of erythrocytes into the film is generally excluded.

7. The test element of claim 1 wherein the support comprises a liquid-impermeable support.

8. The test element of claim 1 wherein the pigment particles are based on TiO₂.

9. The test element of claim 1 wherein the pigment particles are based on ZrO₂.

10. The test element of claim 1 wherein the average diameter of the fine-grained pigment particles is between about 0.1 μ

m and about 0.3 μ

m.

11. The test element of claim 1 wherein the medium or coarse grained particles are selected from the group consisting of TiO₂, BaTiO₃, ZrO₂, ZrSiO₃ and BaSO₄.

12. The test element of claim 1 wherein the medium-grained or coarse-grained particles are selected from the group consisting of SiO₂, a silicate, and a water-insoluble plastic.

13. The test element of claim 1 wherein the average diameter of the medium-grained particles is between about 1 μ

m and about 3 μ

m.

14. The test element of claim 1 wherein the mixture of fine-grained pigment particles and coarse-grained particles has a weight ratio of about 1:

0.2 to about 1;

1.

15. The test element of claim 1 wherein the mixture of fine-grained pigment particles and medium-grained particles has a weight ratio of about 1:

0.2 to about 1;

1.

16. The test element of claim 1 wherein the mixture of fine-grained pigment particles, coarse-grained particles and medium-grained particles has a weight ratio of about 1:

0.1;

0.9.

17. The test element of claim 1 wherein the reagent is present in a polymer matrix.

18. The test element of claim 1 wherein the reagent is formed for the detection of NADH.

19. The test element of claim 1 wherein the reagent is formed for the visible detection an analyte.

20. The test element of claim 1 wherein a reaction period for the detection of the analyte is less than about 5 seconds.

21. The test element of claim 1 wherein a reaction period for the detection of the analyte is about 1 second to about 4 seconds.

22. The test element of claim 1 wherein a reaction period for the detection of the analyte is about 2 seconds.

23. A test element for the optical detection of an analyte comprising:

a support having at least one transparent portion, and

a one-layer film positioned on the support, the film comprising a reagent for the reflection photometric detection of the analyte and pigment particles, wherein the test element is formed to determine the analyte within a reaction period of less than about 5 seconds, and wherein the test element comprises only one functional layer, and wherein the film comprises a mixture of fine-grained pigment particles having an average diameter of less than 0.5 μ

m with medium and/or coarse-grained particles, the average diameter of medium grain particles being between about 0.7 μ

m and about 4 μ

m and the average diameter of coarse-grained particles being between about 4 μ

m and about 8 μ

m.

24. A test element for the optical detection of an analyte comprising:

an at least partially optically essentially transparent support and

a one-layer reaction film positioned on the support and comprising a test reagent for the reflection photometric determination of the analyte and pigment particles, wherein the thickness and porosity of the reaction film and the concentration of the test reagent are adjusted such that the analyte is determined within a reaction period of less than about 5 seconds with a signal intensity that is sufficient for a quantitative determination, and wherein the test element comprises only one functional layer, and wherein the film comprises a mixture of fine-grained pigment particles having an average diameter of less than 0.5 μ

m with medium and/or coarse-grained particles, the average diameter of medium grain particles being between about 0.7 μ

m and about 4 μ

m and the average diameter of coarse-grained particles being between about 4 μ

m and about 8 μ

m.

25. The test element of claim 24 wherein the reaction period is about 1 to about 4 seconds.

26. The test element of claim 24 wherein the reagent is suitable for the determination of an analyte selected from the group consisting of:

glucose, lactate, ketone bodies and urea.

27. The test element of claim 24, wherein the test reagent comprises an enzyme system selected from the group consisting essentially of:

glucose dye oxidoreductase and glucose dehydrogenase.

28. A method for the detection of an analyte in a sample comprising the steps:

contacting the sample with a test element comprising a support having at least one transparent portion, and a one-layer film positioned on the support, the film comprising a reagent for the reflection photometric detection of the analyte and pigment particles, the film having a thickness when dry about 10 μ

m or less and wherein the test element comprises only one functional layer, and wherein the film comprises a mixture of fine-grained pigment particles having an average diameter of less than 0.5 μ

m with medium and/or coarse-grained particles, the average diameter of medium grain particles being between about 0.7 μ

m and about 4 μ

m and the average diameter of coarse-grained particles being between about 4 μ

m and about 8 μ

m; and

determining the analyte concentration in the sample using reflection photometry of the test element.

29. The method of claim 28 wherein the determination takes place within a reaction period of less than about 5 seconds.

30. The method of claim 28 wherein the determination takes place within a reaction period of about 1 to about 4 seconds.

31. The method of claim 28 wherein the analyte is glucose.