Systems and methods of discriminating control solution from a physiological sample

• US 9,274,078 B2
• Filed: 06/21/2013
• Issued: 03/01/2016
• 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): DIETERLE, JENNIFER M
• Application Number:
  US13/924,031
• Publication Number:
  US 20140005949A1
• Time in Patent Office: 984 Days
• US Class Current: 1/1
• 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 calculating a discrimination criteria for programming into a test meter for distinguishing between a blood sample and a control solution sample, the method comprising the steps of:

(a) calculating an interferent index and a residual reaction index for a plurality of control solution samples in which the interferent index is based upon summing of at least two current values measured during a first test potential and the residual reaction index is based upon a ratio of at least two current values measured during a second test potential and third test potential, respectively; and

(b) calculating a discrimination criteria based on a regression of the interferent index and the residual reaction index for the plurality of control solution samples.

2. The method of claim 1, wherein the discrimination criteria is a discrimination line.

3. The method of claim 2, wherein the method further comprises the step of:

plotting an interferent index and a residual reaction index for a plurality of blood samples and shifting the discrimination line towards the plurality of blood samples.

6. The method according to claim 1, further comprising the steps of:

(e) applying a second test potential, having the first polarity, between the electrodes and measuring cell current;

(f) applying a third test potential, having a second polarity opposite of the first polarity between the electrodes and measuring cell current;

(g) determining a residual reaction index based on at least one current value measured during the second and third test potentials;

(h) using the residual reaction index to distinguish between a control sample and a blood sample.

7. The method according to claim 6, in which residual reaction index is based on a ratio of at least one current value measured during the second test potential and at least one current value measured during the third test potential.

4. 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 cell current;

(c) summing at least two current values measured during the first test potential to generate an interferent index;

(d) using the interferent index to distinguish between a blood sample and a control solution sample.

5. The method according to claim 4, wherein the first potential is in the range of about 1 mV and 100 mV.