Systems and methods for discriminating control solution from a physiological sample

• US 8,449,740 B2
• Filed: 07/21/2010
• Issued: 05/28/2013
• 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 M., Teodorczyk, Maria, Dato, Remedios
• Primary Examiner(s): Ball, J. Christopher
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US12/840,595
• Publication Number:
  US 20110011752A1
• Time in Patent Office: 1,042 Days
• Field of Search: 204400-40315, 204/406, 205/777.5, 205/778, 205/792, 205/775, 600/365, 702/19, 422/68.1
• US Class Current: 204/403.12
• 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 system for distinguishing between a blood sample and a control solution sample, the system comprising:

A. a test strip including electrical contacts for mating with a test meter and an electrochemical cell, said cell comprising

(i) a first electrode and a second electrode in a spaced apart relationship, and

(ii) a reagent, and;

B. a test meter including a processor programmed to receive respective first, second and third current transients resulting from respective first, second and third electrical potentials applied to the test strip in which the third electrical potential is opposite in polarity to the first and second potentials, calculates a residual reaction index based on a ratio of the third current to the second current transients and an interferent index, and compares both the residual reaction index and the interferent index with data storage containing discrimination criteria relating to both the residual reaction index and the interferent index to distinguish a blood sample from a control solution sample based on the discrimination criteria.

2. The system of claim 1, further comprising a control solution sample that is substantially devoid of redox species.

3. The system of claim 1, wherein the discrimination criteria is derived from an interferent index that is representative of antioxidant concentration and a residual reaction index that is representative of the percentage of the analyte that is unconsumed.

4. The system of claim 3, wherein the discrimination criteria includes an empirically derived discrimination line.