SYSTEMS AND METHODS OF DISCRIMINATING CONTROL SOLUTION FROM A PHYSIOLOGICAL SAMPLE

• US 20140005949A1
• Filed: 06/21/2013
• Published: 01/02/2014
• 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
• Granted Patent: US 9,274,078 B2
• Time in Patent Office: Days
• US Class Current: 702/19
• 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

1-17. -17. (canceled)

18. 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; 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.

19. The method of claim 18, wherein the discrimination criteria is discrimination line.

20. The method of claim 19, 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.

21. 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.

22. The method according to claim 21, wherein the first potential is in the range of about 1 mV and 100 mV.