Method and test element for electrochemically detecting at least one analyte in a sample of a body fluid

Patent metadata

Field	Value
Publication number	US-10620148-B2
Application number	US-201715830672-A
Country	US
Kind code	B2
Filing date	Dec 4, 2017
Priority date	Jun 15, 2015
Publication date	Apr 14, 2020
Grant date	Apr 14, 2020

Abstract

A method and test element for electrochemically detecting at least one analyte in a sample are provided, wherein the method comprises: a) providing at least one test element comprising at least one first electrode contacting a test chemistry and at least one second electrode, wherein a surface of the second electrode consists of silver metal; b) contacting both the first and second electrodes with the sample comprising chloride ions; c) applying a first voltage between the first electrode as a cathode and the second electrode as an anode with a voltage sufficient for forming a layer of silver chloride at the surface of the second electrode; d) applying a second voltage between the first electrode as the anode and the second electrode as the cathode; and e) determining an electrical signal between the first and the second electrodes, whereby the analyte in the sample comprising the chloride ions is detected.

First claim

What is claimed is:

1. A method for electrochemically detecting at least one analyte in a sample of a body fluid comprising chloride ions, the method comprising the steps:
a) providing at least one test element, wherein the test element comprises at least one first electrode contacting a test chemistry and at least one second electrode, wherein the test chemistry is or comprises a redox mediator in an oxidized form, wherein, in an absence of the sample, a surface of the second electrode adapted to contact the sample of the body fluid consists of silver metal;
b) contacting both the first electrode and the second electrode with the sample of the body fluid comprising the chloride ions;
c) applying a first voltage (V 1 ) between the first electrode as a cathode and the second electrode as an anode for a time and with a voltage sufficient for forming a layer of silver chloride at the surface of the second electrode, wherein the oxidized form of the redox mediator is transformed into a reduced form;
d) applying a second voltage (V 2 ) between the first electrode as the anode and the second electrode as the cathode, wherein
applying the first voltage (V 1 ) is terminated after step c) and a period of time passes before the second voltage (V 2 ) is applied according to step d); and

e) determining an electrical signal between the first electrode and the second electrode, whereby the analyte in the sample of the body fluid comprising the chloride ions is detected, wherein detecting the analyte comprises re-oxidizing the redox mediator.

2. The method of claim 1 , wherein a measurement device adapted to interact with the test element is used to apply the first voltage (V 1 ) and/or the second voltage (V 2 ) between the first electrode and the second electrode.

3. The method of claim 1 , wherein the time during which the first voltage (V 1 ) is applied between the first electrode as the cathode and the second electrode as the anode during step c) is at least 0.2 s.

4. The method of claim 1 , wherein the second electrode comprises a silver layer being disposed on a second electrode carrier layer, wherein the second electrode carrier layer comprises a second electrode carrier foil, wherein the silver layer comprises of a thickness in a range from 10 nm to 1000 nm.

5. The method of claim 1 , wherein the sample of the body fluid comprises blood, plasma, serum, urine, saliva, or an interstitial fluid.

6. The method of claim 5 , wherein the sample of the body fluid comprises whole blood.

7. The method of claim 1 , wherein the period of time that passes before the second voltage (V 2 ) is applied according to step d) is between about 0.5 seconds and about 30 seconds.

8. The method of claim 1 , wherein the period of time that passes before the second voltage (V 2 ) is applied according to step d) is between about 3 seconds and about 10 seconds.

9. A system for determining at least one property of a sample of a body fluid comprising chloride ions, the system comprising at least one test element for electrochemically detecting at least one analyte in a sample of a body fluid comprising chloride ions, wherein the test element comprises at least one first electrode contacting a test chemistry, wherein the test chemistry is or comprises a redox mediator in an oxidized form, and at least one second electrode, wherein, in an absence of the sample, a surface of the second electrode adapted to contact the sample consists of silver metal, the system further comprising at least one measurement device configured for performing at least one electrical measurement by using the test element, wherein the measurement device applies a first voltage (V 1 ) between the first electrode as a cathode and the second electrode as an anode for a time and with a voltage sufficient for forming a layer of silver chloride at the surface of the second electrode, wherein the oxidized form of the redox mediator is transformed into a reduced form, and wherein the measurement device applies a second voltage (V 2 ) between the first electrode as the anode and the second electrode as the cathode, wherein applying the first voltage (V 1 ) is terminated and a period of time passes before the second voltage (V 2 ) is applied.

10. The system of claim 9 , wherein the second electrode comprises a silver layer being disposed on a second electrode carrier layer, wherein the second electrode carrier layer comprises a second electrode carrier foil, wherein the silver layer comprises of a thickness in a range from 10 nm to 1000 nm.

11. The system of claim 9 , further comprising at least one capillary adapted to receive the sample, wherein the first electrode and the second electrode are arranged on opposing sides of the capillary.

12. The system of claim 9 , wherein the period of time that passes before the second voltage (V 2 ) is applied is between about 0.5 seconds and about 30 seconds.

13. The system of claim 9 , wherein the period of time that passes before the second voltage (V 2 ) is applied is between about 3 seconds and about 10 seconds.

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Marquant Michael

Classifications

• G01N27/301 Primary

  Reference electrodes · CPC title

• G01N27/3272 Primary

  Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52) · CPC title

• C12Q1/54

  involving glucose or galactose · CPC title

• C12Q1/006

  for glucose · CPC title