Test element for electrochemically detecting at least one an analyte

Patent metadata

Field	Value
Publication number	US-11099149-B2
Application number	US-201715604017-A
Country	US
Kind code	B2
Filing date	May 24, 2017
Priority date	Dec 19, 2014
Publication date	Aug 24, 2021
Grant date	Aug 24, 2021

Abstract

A test element for electrochemically detecting at least one analyte in a bodily fluid is disclosed. The test element comprises at least one first electrode and at least one second electrode. The first electrode is designed as a working electrode and the second electrode is designed as a counter electrode. The test element comprises at least one capillary capable of receiving a sample of the body fluid. The first electrode and the second electrode are arranged on opposing sides of the capillary. The first electrode and the second electrode are arranged such that during a capillary filling the first electrode and the second electrode are wetted simultaneously and at an equal rate.

First claim

What is claimed is:

1. A system for determining at least one property of a sample, the system comprising at least one test element, wherein the test element comprises at least one first electrode and at least one second electrode, wherein the first electrode is designed as a working electrode and the second electrode is designed as a counter electrode, wherein the test element comprises at least one capillary capable of receiving a sample of the body fluid, wherein the capillary is open at three sides, wherein a sample of bodily fluid is applicable to a side dose position and/or a front dose position, wherein the first electrode and the second electrode are arranged on opposing sides of the capillary, wherein the first electrode and the second electrode and the capillary in between the first electrode and the second electrode form an electrochemical cell, wherein the test element is configured to detect the at least one analyte independently of a filling level of the electrochemical cell, wherein the first electrode and the second electrode are arranged such that during a capillary filling the first electrode and the second electrode are wetted simultaneously and at an equal rate, the system further comprising at least one measurement device adapted for performing at least one electrical measurement using the test element, wherein the measurement device is configured to detect both an AC signal and a DC signal simultaneously, wherein both the AC signal and the DC signal are proportional to the filling level of the capillary such that effects due to a filling level of the capillary are compensated, wherein the measurement device is further configured to form a ratio of the AC signal and the DC signal, wherein the ratio is independent from the filling level of the electrochemical cell, wherein the measurement device is configured to detect the at least one analyte independently of a filling level of the electrochemical cell, wherein the measurement device is configured to apply an AC signal between the at least one first electrode and the at least one second electrode of the test element, wherein the measurement device is configured to measure a response signal over time, wherein the measurement device is configured to compare the response to at least one predefined threshold, wherein the measurement device is configured such that the predetermined threshold is chosen such that a minimum filling level is ensured, and wherein the measurement device is configured such that the predefined threshold is chosen with respect to a specific conductivity of a sample.

2. The system according to claim 1 , wherein the measurement device is further configured to electrically monitor a filling process of the capillary.

3. The system according to claim 1 , wherein the measurement device is configured to perform at least one initial failsafe measurement before applying the sample of bodily fluid.

4. A method for determining at least one property of a sample, wherein a system according to claim 1 is used, wherein the method comprises the following steps:
a) connecting the test element to at least one measurement device;
b) applying a sample of bodily fluid to a capillary of at least one test element;
c) determining both an AC signal and a DC signal with said measurement device;
d) calibrating measurement results by using the AC and DC signal; and
e) determining a filling level of the capillary, wherein an AC signal is applied between the at least one first electrode and the at least one second electrode of the test element, wherein a response signal over time is measured, wherein the response is compared to at least one predefined threshold, wherein the predetermined threshold is chosen such that a minimum filling level is ensured, and wherein the predefined threshold is chosen with respect to a specific conductivity of a sample.

5. The method according to claim 4 , wherein the determination of the AC and DC signal is performed by overlapping excitation potentials.

6. The method according to claim 4 , wherein the method further comprises determining a contact time, wherein an AC signal is applied between at least one first electrode and at least one second electrode of the test element, wherein a response over time is measured, and wherein the response is compared to a predefined threshold.

7. The method according to claim 4 , wherein the method further comprises monitoring a filling process of the capillary, wherein a DC voltage is applied between the first electrode and the second electrode, wherein a DC response is detected, and wherein the DC response is compared to a predefined limit.

8. The system according to claim 1 , wherein the first electrode extends over a full length of the capillary, wherein the second electrode extends over the full length of the capillary, and wherein the first electrode and the second electrode are aligned in parallel.

9. A test element for electrochemically detecting at least one analyte in a bodily fluid, wherein the test element comprises at least one first electrode and at least one second electrode, wherein the first electrode is designed as a working electrode and the second electrode is designed as a counter electrode, wherein the test element comprises at least one capillary capable of receiving a sample of the body fluid, wherein the first electrode and the second electrode are arranged on opposing sides of the capillary, wherein the first electrode and the second electrode and the capillary in between the first electrode and the second electrode form an electrochemical cell, wherein the test element is configured to detect the at least one analyte independently of a filling level of the electrochemical cell, wherein the first electrode and the second electrode are arranged such that during a capillary filling the first electrode and the second electrode are wetted simultaneously and at an equal rate, wherein the first electrode extends over a full length of the capillary, wherein the second electrode extends over the full length of the capillary, wherein the first electrode and the second electrode are aligned in parallel, wherein the capillary is open at three sides, wherein a sample of bodily fluid is applicable to one or both of a side dose position or a front dose position, wherein the test element comprises a first electrode contact zone and a second electrode contact zone configured to contact the first electrode and the second electrode with a further device, wherein the first electrode contact zone and the second electrode contact zone are arranged in different layers of a layer setup of the test element, wherein one of the first electrode contact zone and the second electrode contact zone protrudes over the other one of the first electrode contact zone and the second electrode contact zone, wherein the first electrode contact zone and the second electrode contact zone are configured to be electrically contacted from opposing sides of the test element, wherein the test element comprises a layer setup, wherein the first electrode comprises at least one first electrode conductive layer disposed on at least one first electrode carrier layer, wherein the second electrode comprises at least one second electrode conductive layer disposed on at least one second electrode carrier layer, and wherein at least one spacer layer is disposed in between the first electrode conductive layer and the second electrode conductive layer, wherein said further device comprises at least one measurement device adapted for performing at least one electrical measurement using the test element, wherein the measurement device is configured to apply an AC signal between the at least one first electrode and the at least one second electrode of the test eleme

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Bauer-Espindola Klaus Andreas
• Marquant Michael
• Nortmeyer Christine
• Stein Reiner

Classifications

• G01N27/3272 Primary

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

• G01N27/3274

  Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771) · CPC title

• G01N33/487

  of liquid biological material · CPC title

• C12Q1/006

  for glucose · CPC title

• G01N27/04

  by investigating resistance · CPC title