Interference compensating two electrodes test strip

Patent metadata

Field	Value
Publication number	US-10590458-B2
Application number	US-201715442202-A
Country	US
Kind code	B2
Filing date	Feb 24, 2017
Priority date	Aug 25, 2014
Publication date	Mar 17, 2020
Grant date	Mar 17, 2020

Abstract

A method of detecting at least one analyte in a test sample is provided comprising a) contacting the test sample (i) to an active chemistry matrix changing at least one electrochemical property dependent on an enzymatic activity active in the presence of the analyte, the active chemistry matrix contacting a first electrode; and (ii) to an inactive chemistry matrix, the inactive chemistry matrix contacting a second electrode, b) closing an electrical circuit including the first electrode, the second electrode, and the active chemistry matrix and inactive chemistry matrix, followed by determining a first value of the at least one electrochemical property, c) inverting electrical polarity of the electrical circuit of b), followed by determining a second value of the at least one electrochemical property, and d) detecting the at least one analyte based on the first value and on the second value.

First claim

What is claimed is:

1. A method of detecting at least one analyte in a test sample, said method comprising the steps of
a) contacting said test sample (i) to an active chemistry matrix changing at least one electrochemical property dependent on an enzymatic activity active in said active chemistry matrix in the presence of said analyte, said active chemistry matrix comprising said enzymatic activity, said active chemistry matrix contacting a first electrode; and (ii) to an inactive chemistry matrix, said inactive chemistry matrix not comprising said enzymatic activity, said inactive chemistry matrix contacting a second electrode,
b) closing an electrical circuit including said first electrode, said second electrode, and said active and inactive chemistry matrices to apply an electrical polarity to the electrical circuit, followed by determining a first value of said at least one electrochemical property,
c) inverting said electrical polarity of the electrical circuit of step b), followed by determining a second value of said at least one electrochemical property, and
d) detecting said at least one analyte based on said first value and on said second value.

2. The method of claim 1 , wherein detecting said at least one analyte comprises calculating a difference between said first value determined in step b) and said second value determined in step c).

3. The method of claim 1 , wherein step b) comprises applying a voltage to said electrical circuit.

4. The method of claim 3 , wherein step c) comprises applying a voltage inverted relative to the voltage of step b) to said electrical circuit.

5. The method of claim 1 , wherein the voltage applied in step c) corresponds to the voltage applied in step b) ±40%.

6. The method of claim 1 , wherein the composition of said active chemistry matrix differs from the composition of said inactive chemistry matrix only by the presence of said enzymatic activity.

7. The method of claim 1 , wherein said active chemistry matrix comprises a polypeptide having said enzymatic activity and wherein said inactive chemistry matrix comprises a polypeptide not having said enzymatic activity.

8. The method of claim 1 , wherein said analyte is glucose.

9. The method of claim 1 , wherein said analyte is comprised in a test sample.

10. The method of claim 1 , wherein said analyte is comprised in a blood test sample.

11. The method of claim 1 in which said contacting provides electrical communication between the first and second electrodes.

12. The method of claim 1 in which said closing an electrical circuit comprises applying a first voltage across the first and second electrodes.

13. The method of claim 1 in which said inverting electrical polarity comprises applying a second voltage that is opposite in polarity to the first voltage.

14. The method of claim 1 in which said detecting is based on a correlation between said first value and said second value.

15. The method of claim 1 wherein said active and inactive chemistry matrices are arranged adjacent to each other such that both chemistry matrices are wetted by the test sample simultaneously.

16. The method of claim 1 wherein said active chemistry matrix is in contact with said inactive chemistry matrix.

17. The method of claim 1 and which further includes providing a voltage free period between the first voltage and the second voltage.

18. The method of claim 1 in which the first and second electrodes are coplanar.

19. The method of claim 1 in which the first and second electrodes are arranged face-to-face.

20. The method of claim 19 in which the first and second electrodes are received within a capillary.

21. The method of claim 1 , wherein the first and second electrodes are electrically insulated from any additional electrode potentially present such that (i) the resistance between the first electrode and any additional electrodes, and (ii) the resistance between the second electrode and any additional electrode, are both at least 25 kΩ after said contacting of said test sample to the first and second electrodes.

22. The method of claim 1 wherein said active chemistry matrix comprises a polypeptide having said enzymatic activity and wherein said inactive chemistry matrix comprises a polypeptide not having said enzymatic activity, the composition of said active chemistry matrix differing from the composition of said inactive chemistry matrix only by the presence of said enzymatic activity.

23. The method of claim 1 wherein said contacting of the first and second electrodes is without contacting a reference electrode.

24. The method of claim 1 wherein said contacting comprises contacting said test sample with one or more capillary elements guiding said test sample to the first and second electrodes.

25. The method of claim 24 , wherein the first electrode and the second electrode are arranged on opposing sides of said one or more capillary elements.

26. A test device for detecting at least one analyte in a test sample, comprising
i) a receptacle for receiving a sensor element, the sensor element comprising at least two electrodes and at least an active chemistry matrix and an inactive chemistry matrix, the active chemistry matrix changing at least one electrochemical property dependent on an enzymatic activity active in said chemistry matrix in the presence of said analyte, a first electrode contacting said active chemistry matrix comprising said enzymatic activity, and a second electrode contacting said inactive chemistry matrix not comprising said enzymatic activity;
ii) a measuring unit in electrical contact with the two electrodes of the sensor element when received within the receptacle, the measuring unit configured to apply a first voltage across the electrodes and to determine a first value of said at least one electrochemical property, the measuring unit configured to apply a second voltage of opposite polarity across the electrodes and to determine second value of said at least one electrochemical property; and
iii) a data processing device configured to receive the first and second values from the measuring unit and to detect at least one analyte based on the first and second values.

27. A test system comprising
i) a sensor element comprising at least two electrodes electrically and at least an active chemistry matrix and an inactive chemistry matrix, said active chemistry matrix changing at least one electrochemical property dependent on an enzymatic activity active in the presence of said analyte, a first electrode contacting said active chemistry matrix comprising said enzymatic activity, and a second electrode contacting said inactive chemistry matrix not comprising said enzymatic activity; and
ii) a test device comprising a receptacle for the sensor element, the test element being received within the receptacle,
said test device comprising a measuring unit in electrical contact with the two electrodes of said sensor element received within the receptacle, the measuring unit being configured to apply a first voltage across the electrodes and to determine a first value of said at least one electrochemical property, the measuring unit being configured to apply a second voltage of opposite polarity across the electrodes and to determine a second value of said at least one electrochemical property,
said test device further comprising a data processing device configured to receive

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Marquant Michael
• Reinhardt Michael

Classifications

• G01N33/48707

  by electrical means (G01N33/49, G01N33/493 take precedence) · CPC title

• G01N33/48721

  Investigating individual macromolecules, e.g. by translocation through nanopores (Coulter counters in general G01N15/12; fabrication methods for nanoscale apertures B81B1/00; sequencing of nucleic acids C12Q1/68) · CPC title

• C12Q1/006 Primary

  for glucose · CPC title

• G01N27/3274

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

• G01N33/49

  Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)} · CPC title