Systems and methods for discriminating control solution from a physiological sample

• US 8,529,751 B2
• Filed: 03/31/2006
• Issued: 09/10/2013
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Chatelier, Ronald C., Hodges, Alastair McIndoe, Teodorczyk, Maria, Dato, Remedios
• Primary Examiner(s): Ball, J. Christopher
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US11/278,333
• Publication Number:
  US 20070235347A1
• Time in Patent Office: 2,720 Days
• Field of Search: 205/792, 205/775, 205/777.5, 205/787, 205/778, 204/400, 20440301-40315, 600345-348
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include 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 a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.

Claims

1. A method for distinguishing between a blood sample and a control solution sample, the method comprising the steps of:

(a) introducing a sample into an electrochemical cell, the electrochemical cell comprising;

(i) two electrodes in a spaced apart relationship; and

(ii) a reagent;

(b) applying a first test potential, having a first polarity, between the electrodes, and measuring a first current transient;

(c) applying a second test potential, having a first polarity, between electrodes, and measuring a second current transient;

(d) applying a third test potential, having a second polarity, between the electrodes, and measuring a third current transient;

(e) calculating, based on the first current transient, a first reference value related to the quantity of redox species in the sample;

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

(g) determining, based on the first and second reference values, whether the sample is a control solution sample or blood sample.

2. The method of claim 1, wherein the first reference value is proportional to a concentration of an interferent in the sample.

3. The method of claim 2, wherein the first reference value is an interferent index calculated based upon at least one current value from the first current transient.

4. The method of claim 1, wherein the second reference value is a function of a percent completion of a chemical reaction.

5. The method of claim 4, wherein the second reference value is a residual reaction index calculated based upon at least one current value from the second current transient and at least one current value from the third current transient.

6. The method of claim 5, wherein the residual reaction index is calculated based upon a ratio of at least one current value from the second current transient and at least one current value from the third current transient.

7. The method of claim 1, further comprising performing the step of measuring a concentration of an analyte in a control solution sample or a blood sample.

8. The method of claim 7, wherein if the sample is found to be a control solution sample the analyte concentration associated with the control solution sample is flagged.

9. The method of claim 1, wherein the second polarity is opposite from both the first test potential first polarity and the second test potential first polarity.

10. The method of claim 1, wherein step (g) further comprises using statistical classification to determine if the sample is a control solution sample or a blood sample.

11. The method of claim 1, further comprising in step (g), an equation representing a discrimination line to evaluate the first and second reference values.

12. The method of claim 1, further comprising the step of applying a first open-circuit potential to the electrochemical cell before the step of applying the first test potential.

13. The method of claim 12, further comprising the step of applying a second open-circuit potential to the electrochemical cell after the step of applying the first test potential.