Multi-region and potential test sensors, methods, and systems

Patent metadata

Field	Value
Publication number	US-10895550-B2
Application number	US-201715809365-A
Country	US
Kind code	B2
Filing date	Nov 10, 2017
Priority date	Sep 24, 2007
Publication date	Jan 19, 2021
Grant date	Jan 19, 2021

Abstract

Biosensor systems including a measurement device and test sensors including at least three independently addressable electrodes, with at least two of the electrodes being substantially chemically isolated are disclosed. One or more working electrodes may be combined with two or more counter electrodes. The two or more counter electrodes may operate at different potentials to provide for multi-analyte electrochemical analysis. Analysis methods are provided to perform multi-analyte electrochemical analysis and test sensors are provided having resistance to chemical mixing between secondary analysis regions.

First claim

What is claimed is:

1. A method of measuring at least one analyte in a sample, the method comprising:
providing a test sensor including a sample interface disposed on a first substrate in the form of a base, the sample interface being in electrical communication with a reservoir formed by combining the first substrate and a second substrate in the form of a lid, the reservoir having a primary area with at least one sample port and at least eight secondary analysis regions, the eight secondary analysis regions including a first region, a second region, a third region, a fourth region, a fifth region, a sixth region, a seventh region, and an eighth region, the eight secondary analysis regions being distinct, separate, and structurally isolated such that chemical analysis of diffusive or convective mixing of reagents is different in each of the secondary analysis regions during one or more analyses of a sample, the at least one sample port being where sample introduction occurs into the test sensor;
providing four working electrodes and four counter electrodes including a first working electrode, a second working electrode, a third working electrode, a fourth working electrode, a first counter electrode, a second counter electrode, a third counter electrode, and a fourth counter electrode, each electrode of the four working electrodes and the four counter electrodes being distinct and separate, each of the four working electrodes including a first conductor and a reagent composition, each of the reagent compositions having a different redox potential, each of the four counter electrodes including a second conductor and at least one redox species, the redox species of at least one counter electrode being different than the redox species of another counter electrode, the first conductors of the four working electrodes being electrically connected, the second conductors of the four counter electrodes not being electrically connected, each of the four working electrodes and the four counter electrodes being disposed in a respective separate one of the eight secondary analysis regions such that the first region has the first working electrode and its respective first conductor and reagent composition, the second region has the second working electrode and its respective first conductor and reagent composition, the third region has the third working electrode and its respective first conductor and reagent composition, the fourth region has the fourth working electrode and its respective first conductor and reagent composition, the fifth region has the first counter electrode and its respective second conductor and at least one redox species, the sixth region has the second counter electrode and its respective second conductor and at least one redox species, the seventh region has the third counter electrode and its respective second conductor and at least one redox species, and the eighth region has the fourth counter electrode and its respective second conductor and at least one redox species;
providing a sensor interface in electrical communication with each of the first conductors and the second conductors in the reservoir;
providing a measurement device including a computer readable storage medium, a processor, and a signal generator, the signal generator being in electrical communication with the sensor interface, the sensor interface being in electrical communication with the sample interface, the processor being programmed to:
apply a first input signal at a first potential from the signal generator to at least one of the four working electrodes and at least a first counter electrode of the four counter electrodes,
apply a second input signal at a second potential from the signal generator to at least one of the four working electrodes and at least a second counter electrode of the four counter electrodes,
measure a first output signal from at least one of the four working electrodes and the first counter electrode, the first output signal being responsive to the first input signal,
measure a second output signal from at least one of the four working electrodes and the second counter electrode, the second output signal being responsive to the second input signal,
analyze the first and the second output signals,
determine a first concentration of at least one first measurable species in a biological sample disposed in the reservoir at the potential of the first input signal,
determine a second concentration of at least one second measurable species in the biological sample disposed in the reservoir at the potential of the second input signal, and
convert at least one of the first and the second concentrations into a concentration of the at least one analyte in the biological sample disposed in the reservoir.

2. The method of claim 1 , wherein the processor is further programmed to:
apply a third input signal at a third potential that is different than the first potential and the second potential input, the third input signal being applied to at least one of the four working electrodes and at least a third counter electrode of the four counter electrodes;
measure a third output signal from at least one of the four working electrodes and the third counter electrode, the third output signal being responsive to the third input signal;
analyze the third output signal;
determine a third concentration of at least one third measurable species in the biological sample disposed in the reservoir at the potential of the third input signal; and
convert at least one of the first, the second, and the third measurable species concentrations into the concentration of the at least one analyte in the biological sample disposed in the reservoir.

3. The method of claim 1 , wherein the processor is further programmed to:
convert the first concentration of the first measurable species into the concentration of the at least one analyte in the biological sample disposed in the reservoir; and
alter with the second concentration of the second measurable species at least one of
the concentration value of the at least one analyte in the biological sample disposed in the reservoir, and
a correlation equation from which the concentration value of the at least one analyte in the biological sample is determined.

Assignees

• Ascensia Diabetes Care Holdings Ag

Inventors

• Wu Huan-Ping
• Zhong Weiping
• Perry Joseph E
• Maurer Eric
• Jung Sung-Kwon

Classifications

• C12Q1/001

  Enzyme 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

• G01N27/3274

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