Test element for electrochemically detecting at least one analyte
Inventors
Bauer-Espindola, Klaus Andreas • Marquant, Michael • Nortmeyer, Christine • Stein, Reiner
Assignees
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Publication Number
US-11774395-B2
Publication Date
2023-10-03
Expiration Date
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.
Core Innovation
The invention relates to a system for determining at least one property of a sample, where the sample is a body fluid and the system comprises at least one test element with a capillary electrochemical cell. The test element includes at least one first electrode designed as a working electrode and at least one second electrode designed as a counter electrode, with the first electrode and second electrode arranged on opposing sides of the capillary. The capillary is open at three sides and a sample of body fluid is applicable to a side dose position and/or a front dose position, so that the first electrode, the capillary, and the second electrode form an electrochemical cell.
The core feature is that the test element is configured to detect the at least one analyte independently of a filling level of the electrochemical cell. This is achieved by arranging the first electrode and second electrode so that during a capillary filling the first electrode and second electrode are wetted simultaneously and at an equal rate. As a result, electrode wetting behavior during filling is coordinated between the working and counter electrodes to support filling-level-independent detection.
To compensate for filling level effects in electrical measurements, the system further includes at least one measurement device adapted for performing at least one electrical measurement. The measurement device is configured to detect both an AC signal and a DC signal simultaneously, where both signals are proportional to the filling level of the capillary, and where effects due to a filling level of the capillary are compensated. The measurement device forms a ratio of the AC signal and the DC signal such that the ratio is independent from the filling level of the electrochemical cell, while the measurement device is configured to apply an AC signal between the working electrode and the counter electrode.
Claims Coverage
The partial content identifies two independent claims: clm-00001 (a system) and clm-00011 (a test element). Across both, the inventive scope centers on electrochemical analyte detection in a capillary cell with working and counter electrodes arranged on opposing sides, with detection configured to be independent of capillary filling level using coordinated simultaneous equal-rate wetting and filling-level-compensated electrical measurement via AC/DC simultaneous detection and an AC/DC ratio independent from filling level.
Independent analyte detection independent of filling level by simultaneous equal-rate electrode wetting
A test element configured to detect the at least one analyte independently of a filling level of the electrochemical cell, where 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.
Capillary electrochemical cell with working and counter electrodes on opposing sides and open at three sides
A test element comprising at least one capillary capable of receiving a sample of the body fluid, where the capillary is open at three sides, and where the first electrode designed as a working electrode and the second electrode designed as a counter electrode are arranged on opposing sides of the capillary so that the first electrode and the second electrode and the capillary in between form an electrochemical cell.
Filling-level compensation via simultaneous AC and DC measurement and AC/DC ratio independent of filling level
A measurement device configured to detect both an AC signal and a DC signal simultaneously, where 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 by forming a ratio of the AC signal and the DC signal, where the ratio is independent from the filling level of the electrochemical cell.
AC excitation between working electrode and counter electrode
A measurement device configured to apply an AC signal between the at least one first electrode and the at least one second electrode of the test element.
Parallel full-length electrodes and contact zones in different layers separated by a spacer layer
A test element where the first electrode extends over a full length of the capillary and the second electrode extends over a full length of the capillary, where the first electrode and the second electrode are aligned in parallel, and where the test element comprises a first electrode contact zone and a second electrode contact zone arranged in different layers of a layer setup, separated by a spacer layer disposed in between the first electrode conductive layer and the second electrode conductive layer.
Layered electrode construction with conductive layers on carrier layers and spacer layer
A layer setup where the first electrode comprises at least one first electrode conductive layer disposed on at least one first electrode carrier layer, where 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.
The claim set (as provided) defines both a system and a test element for electrochemically detecting analytes in a body fluid using a capillary electrochemical cell formed by a working electrode and a counter electrode arranged on opposing sides. The detection is configured to be independent of capillary filling level by simultaneously equal-rate wetting of the electrodes during capillary filling and by compensating filling-level effects through simultaneous AC and DC electrical measurement and an AC/DC ratio independent from filling level, with AC applied between the electrodes. The test element claim further specifies full-length parallel electrodes and a layered construction with separate contact zones in different layers and a spacer layer between conductive layers.
Stated Advantages
Detecting the at least one analyte independently of a filling level of the electrochemical cell.
Compensating effects due to a filling level of the capillary by using simultaneous AC and DC signals and forming an AC/DC ratio independent from filling level.
Documented Applications
Electrochemical detection of at least one analyte in bodily fluid using a capillary electrochemical cell with working and counter electrodes.
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