Methods of determining an analyte concentration that include correction information for at least one interfering variable

Patent metadata

Field	Value
Publication number	US-9255286-B2
Application number	US-201414310438-A
Country	US
Kind code	B2
Filing date	Jun 20, 2014
Priority date	Dec 22, 2011
Publication date	Feb 9, 2016
Grant date	Feb 9, 2016

Abstract

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

First claim

The invention claimed is:

1. A method of determining at least one analyte concentration in a sample having at least one interfering variable, the method comprising the steps of:
detecting at least one diffusion of a diffusable label in the sample or at least part of the sample applied to at least one test element having the diffusable label and at least one test chemistry to obtain at least one piece of correction information from the detected diffusion of the diffusable label, wherein the at least one piece of correction information accounts for an influence of the at least one interfering variable and accounts for a general relationship between the at least one interfering variable and diffusion of the diffusable label, and wherein the general relationship is obtained from at least one, pre-determined calibration measurement;
detecting at least one reaction between the at least one analyte and the test chemistry of the at least one test element; and
determining the analyte concentration from the at least one reaction of the test chemistry with the at least one analyte while taking into account the at least one piece of correction information, wherein the at least one piece of correction information controls for a temperature of the sample and/or a temperature of the at least one test element during determining the analyte concentration.

2. The method of claim 1 , wherein the at least one interfering variable is a proportion of constituents of at least one substance in the sample.

3. The method of claim 1 , wherein the step of detecting at least one diffusion of the diffusable label is an electrochemical detection, an optical detection or a combination thereof, and wherein the step of detecting at least one reaction between the at least analyte and the test chemistry is an electrochemical detection, an optical detection or a combination thereof.

4. The method of claim 1 , wherein the test element comprises at least one test field having at least one test chemistry layer that comprises the at least one test chemistry.

5. The method of claim 4 , wherein the at least one test chemistry comprises at least one enzyme.

6. The method of claim 5 , wherein the at least one enzyme is selected from the group consisting of glucose dehydrogenase and glucose oxidase.

7. The method of claim 1 , wherein the diffusable label is contained in at least one first region of the test element, and wherein the at least one test chemistry is completely or partly contained in the at least one first region.

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

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

10. The method of claim 1 , wherein the diffusable label absorbs light within a wavelength range from about 300 nm to about 800 nm.

11. The method of claim 1 , wherein the diffusable label is a dye.

12. The method of claim 11 , wherein the dye comprises at least one optically detectable dye.

13. The method of claim 12 , wherein the at least one optically detectable dye is hydrophilic or water-soluble.

14. The method of claim 11 , wherein the dye is selected from the group consisting of cyanine dyes, azo dyes, sulfone dyes, and a combination of at least two thereof.

15. The method of claim 1 , wherein the 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.

16. The method of claim 15 , wherein the diffusable label is erioglaucine or hydroxynaphthol blue.

17. The method of claim 1 , wherein the diffusable label and at least one further diffusable label different from the first diffusable label are used to obtain the at least one piece of correction information, 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 further diffusable label is influenced by at least one further property of the sample different from the first property.

18. The method of claim 1 , wherein the reaction of the at least one test chemistry with the analyte is detected by means of at least one first detector, and wherein diffusion of the diffusable label is detected by means of at least one further detector.

Assignees

• Roche Diabetes Care Inc

Inventors

• Horn Carina
• Unkrig Volker

Classifications

• G01N21/8483

  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 title

• A61B5/14546

  for measuring analytes not otherwise provided for, e.g. ions, cytochromes · CPC title

• A61B5/1486

  using enzyme electrodes, e.g. with immobilised oxidase · CPC title

• A61B5/14535

  for measuring haematocrit · CPC title

• A61B2562/0295

  Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 · CPC title