Test elements for determining an analyte concentration that include correction information for at least one interfering variable

Patent metadata

Field	Value
Publication number	US-9670524-B2
Application number	US-201514961483-A
Country	US
Kind code	B2
Filing date	Dec 7, 2015
Priority date	Dec 22, 2011
Publication date	Jun 6, 2017
Grant date	Jun 6, 2017

Abstract

Test elements are disclosed for detecting at least one analyte concentration in a sample. The test elements are used for detecting one or more analytes such as metabolites in body fluids, especially glucose. The test elements correct for an interfering variable such as temperature and or hematocrit in a test element system via a correction factor based upon diffusion of at least one diffusable label.

First claim

The invention claimed is:

1. A test element for determining at least one analyte concentration in a sample having at least one interfering variable, the test element comprising:
at least one test chemistry on a test support of the test element, wherein the at least one test chemistry is configured to carry out at least one detectable reaction with at least one analyte, wherein the test chemistry is completely or partly contained in at least one first region of the test support of the test element; and
at least one diffusable label in the at least one first region of the test element, wherein the at least one diffusable label is configured to diffuse at least partly from the at least one first region of the test element into at least one second region of the test element,
wherein the at least one test chemistry and the at least one diffusable label provide at least one piece of correction information from a detected diffusion of the at least one diffusable label, the at least one piece of correction information accounting for an influence of the at least one interfering variable and accounting for a general relationship between the at least one interfering variable and diffusion of the at least one diffusable label, wherein the at least one interfering variable is one or more of a temperature of the sample, a temperature of a testing environment, and hematocrit of the sample, and wherein the general relationship is obtained from at least one, predetermined calibration measurement.

2. The test element of claim 1 , wherein the at least one test chemistry comprises at least one enzyme.

3. The test element of claim 2 , wherein the at least one enzyme is selected from the group consisting of glucose dehydrogenase and glucose oxidase.

4. The test element of claim 1 , wherein the at least one diffusable label is a dye.

5. The test element of claim 4 , wherein the dye comprises at least one optically detectable dye.

6. The test element of claim 5 , wherein the at least one optically detectable dye is hydrophilic or water-soluble.

7. The test element of claim 6 , wherein the at least one optically detectable dye is selected from the group consisting of cyanine dyes, azo dyes, sulfone dyes, and a combination of at least two thereof.

8. The test element of claim 1 , wherein the at least one diffusable label is selected from the group consisting of erioglaucine, indigo carmine, hydroxynaphthol blue, 1,1-diethyl-4,4-carbocyanine iodide, amaranth, and a combination of at least two thereof.

9. The test element of claim 8 , wherein the at least one diffusable label is erioglaucine or hydroxynaphthol blue.

10. The test element of claim 1 , wherein the at least one test chemistry comprises an enzyme selected from the group consisting of glucose dehydrogenase and glucose oxidase, and wherein the at least one diff usable label is selected from the group consisting of erioglaucine, indigo carmine, hydroxynaphthol blue, 1,1-diethyl-4,4-carbocyanine iodide, amaranth, and a combination of at least two thereof.

11. The test element of claim 1 , further comprising at least one test field having at least one test chemistry layer that comprises the at least one test chemistry.

12. The test element of claim 1 , wherein the at least one diffusable label is arranged completely or partly separately from the at least one test chemistry.

13. The test element of claim 1 , wherein the at least one diffusable label does not react with one or both of the at least one analyte or the at least one test chemistry, and wherein a diffusion rate of the at least one diffusable label is substantially independent of the at least one analyte concentration.

14. The test element of claim 1 , wherein the at least one diffusable label absorbs light within a wavelength range from about 300 nm to about 800 nm.

15. The test element of claim 1 , wherein the at least one interfering variable is selected from the group consisting of a temperature of the sample, a temperature of the test element, a proportion of constituents of at least one substance in the sample, and a combination of at least two thereof.

16. The test element of claim 1 , wherein the at least one diffusable label is a first diffusible label and the test element further comprises at least one second diffusable label different from the first diffusable label, wherein a diffusion rate of the first diffusable label is influenced by at least one first property of the sample, and wherein a diffusion rate of the at least one second diffusable label is influenced by at least one second property of the sample different from the at least one first property.

Assignees

• Roche Diabetes Care Inc
• Roche Diabetes Care Inc

Inventors

• Horn Carina
• Unkrig Volker

Classifications

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• G01N2021/7786

  Fluorescence · CPC title

• A61B5/14535

  for measuring haematocrit · CPC title

• C12Q1/54 Primary

  involving glucose or galactose · CPC title

• G01N21/78

  producing a change of colour · CPC title