Systems and methods of discriminating between a control sample and a test fluid using capacitance

• US 9,575,026 B2
• Filed: 11/22/2013
• Issued: 02/21/2017
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Chatelier, Ronald C., Hodges, Alastair M.
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US14/087,409
• Publication Number:
  US 20140151243A1
• Time in Patent Office: 1,187 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: G01N 27/28 Electrolytic cell components
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence

Abstract

Methods for distinguishing between an aqueous non-blood sample (e.g., a control solution) and a blood sample are provided herein. In one aspect, the method includes using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or an aqueous non-blood sample based on characteristics of the sample (e.g., amount of interferent present, reaction kinetics, and/or capacitance). The method can also include calculating a discrimination criteria based upon these characteristics. Various aspects of a system for distinguishing between a blood sample and an aqueous non-blood sample are also provided herein.

Claims

1. A method for distinguishing between a blood sample and an aqueous non-blood sample, the method comprising:

(a) applying a first test potential between a first electrode and a second electrode when a sample is introduced into an electrochemical cell and measuring a first current transient;

(b) applying a second test potential between a first electrode and a second electrode, the second test potential being sufficient to oxidize a reduced mediator at the second electrode and measuring a second current transient;

(c) measuring a capacitance of the electrochemical cell;

(d) applying a third test potential between a first electrode and a second electrode, the third test potential being sufficient to oxidize a reduced mediator at the first electrode, and measuring a third current transient;

(e) calculating, based on the first current transient, a first reference value;

(f) calculating, based on the second and third current transients, a second reference value;

(g) calculating, based on at least the measured capacitance, a capacitance index (C_av/C_m);

(h) calculating, based on the first reference value and the capacitance index, a third reference value; and

(i) determining, based on the second and third reference values, whether the sample is a blood sample or an aqueous non-blood sample,wherein the capacitance index is a ratio of an average predetermined capacitance of electrochemical cells of the same type (C_av) and the measured capacitance of the electrochemical cell (C_m).

2. The method of claim 1, wherein the capacitance index is proportional to said measured capacitance of the electrochemical cell.

3. The method of claim 1, wherein the first reference value is calculated based upon at least one current value from the first current transient.

4. The method of claim 1, wherein the first reference value is calculated based upon a summation of current values measured during the first current transient.

5. The method of claim 4, wherein the summation is represented by an equation, the equation being

6. The method of claim 1, wherein the second reference value is based on a percent completion of a chemical reaction.

7. The method of claim 1, wherein the second reference value is based upon at least one current value from the second current transient and at least one current value from the third current transient.

8. The method of claim 1, wherein the second reference value is based upon a second current value at about the end of the second current transient and a third current value at about the beginning of the third current transient.

9. The method of claim 8, wherein the second reference value is based upon a ratio of the second current value and the third current value.

10. The method of claim 1, further comprising the step of measuring a concentration of an analyte.

11. The method of claim 10, wherein if the sample is found to be an aqueous non-blood sample the analyte concentration associated with the aqueous non-blood sample is flagged.

12. The method of claim 1, wherein step (i) further comprises using two inequalities to determine if the sample is an aqueous non-blood sample or a blood sample.

13. The method of claim 1, wherein step (i) further comprises:

comparing the second reference value to a pre-determined threshold equation; and

comparing the third reference value to a pre-determined threshold value to determine if the sample is an aqueous non-blood sample or a blood sample.

14. The method of claim 13, wherein the pre-determined threshold equation is a function of the third reference value.

15. The method of claim 1, wherein the aqueous non-blood sample comprises a control sample.