IP Library Granted Patent US 7,909,983
Granted Patent B2
US 7,909,983 · App. 11/417,225 · Granted Mar 22, 2011

System and methods for automatically recognizing a control solution

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Quick Facts
Patent No.
US 7,909,983
App. No.
11/417,225
Granted
Mar 22, 2011
Kind
B2
Abstract

Methods and devices for automatically distinguishing between a control solution and an actual patient/user sample in a biosensor are provided. The solution is introduced into an electrochemical cell having a working and counter electrode. Electric pulses are applied to the cell and resultant signals are measured. Based on a comparison of the measured signals, a meter can determine whether the sample is a control solution or an actual patient/user sample.

Claims (23)

1. A method for automatically distinguishing between a control solution and an actual patient/user sample in a biosensor comprising:

(a) providing an electrochemical cell comprising:

(i) spaced apart working and counter electrodes; and

(ii) a dry reaction reagent system comprising:

an oxidation-reduction enzyme specific for an analyte;

a first reversible redox species capable of being an electron mediator for the oxidation-reduction enzyme; and

a second reversible redox species, wherein the second redox species has a redox potential different from that of the first redox species;

(b) introducing into the electrochemical cell, a control solution having a known, predetermined concentration of the analyte;

(c) applying at least one electric pulse configured to oxidize or reduce only the first redox species to the electrochemical cell and measuring a first resulting electrical property of the cell;

(d) applying at least one electric pulse configured to oxidize or reduce only the second redox species to the cell and measuring a second resulting electrical property of the cell;

(e) comparing the first and second measurements; and

(f) determining the presence or absence of a control solution based on the results of the comparison performed in part (e).

2. The method of claim 1 , wherein the analyte is glucose.

3. The method of claim 1 , wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through multi-step chronoamperometry.

4. The method of claim 1 , wherein the first and second electrical properties measured are electrochemical signals comprised electric current signals obtained through square wave voltammetry.

5. The method of claim 1 , wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through differential pulse amperometry.

6. The method of claim 1 , wherein the first and second electrical properties measured are electrochemical signals comprised of electric current signals obtained through cyclic voltammetry.

7. The method of claim 1 , wherein the second reversible redox species is oxidized or reduced at a potential having a magnitude at least 0.2 volts greater or less than that used to oxidize or reduce the first electron mediator.

8. The method of claim 1 , wherein the redox potential of the first reversible redox species is different from the redox potential of the second electron mediator.

9. The method of claim 1 , wherein the second reversible redox species is Ferrocene Dicarboxylic Acid.

10. The method of claim 1 , wherein the second reversible redox species is Ferrocenecarboxylic Acid.

11. The method of claim 1 , wherein the second reversible redox species is gentisic acid (2,5-dihydroxybenzoic acid).

12. The method of claim 1 , wherein the second reversible redox species is 2,3,4-trihydroxybenzoic acid.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Aug 29, 2025
From: WELLS FARGO BANK, NATIONAL ASSOCIATION
To: TRIVIDIA HEALTH, INC.
Reel/Frame 072743/0697 →
CHANGE OF NAME Recorded Mar 4, 2016
From: NIPRO DIAGNOSTICS, INC.
To: TRIVIDIA HEALTH, INC.
Reel/Frame 038002/0867 →
SECURITY AGREEMENT Recorded Nov 5, 2013
From: NIPRO DIAGNOSTICS, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 031580/0094 →
RELEASE OF SECURITY INTEREST Recorded Nov 5, 2013
From: REGIONS BANK
To: NIPRO DIAGNOSTICS, INC.
Reel/Frame 031581/0955 →
SECURITY AGREEMENT Recorded Aug 24, 2012
From: NIPRO DIAGNOSTICS, INC.
To: REGIONS BANK
Reel/Frame 028840/0948 →
CHANGE OF NAME Recorded Jul 14, 2010
From: HOME DIAGNOSTICS, INC.
To: NIPRO DIAGNOSTICS, INC.
Reel/Frame 024678/0455 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2006
From: POPOVICH, NATASHA D.; DAVIES, STEPHEN G.
To: HOME DIAGNOSTICS, INC.
Reel/Frame 017979/0929 →