SYSTEMS AND METHODS OF DISCRIMINATING CONTROL SOLUTION FROM A PHYSIOLOGICAL SAMPLE

• US 20130001103A1
• Filed: 09/12/2012
• Published: 01/03/2013
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Chatelier, Ronald C., Hodges, Alastair M.
• Granted Patent: US 9,157,110 B2
• Time in Patent Office: Days
• US Class Current: 205/782
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• 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 33/5438 Electrodes
• CPC Class Codes: G01N 33/96 involving blood or serum control standard

Abstract

Methods for distinguishing between an aqueous non-blood sample (e.g., 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 an aqueous non-blood sample based on at least two characteristics (e.g., amount of interferent present and reaction kinetics). The method can also include calculating a discrimination criteria based upon at least two characteristics. Various aspects of a system for distinguishing between blood samples and an aqueous non-blood sample are also provided herein.

Claims

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

(a) a test strip including electrical contacts for mating with a test meter and an electrochemical 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 adapted to receive current data from the test strip, and data storage containing discrimination criteria for distinguishing a blood sample from an aqueous non-blood sample based on antioxidant concentration and reaction kinetics.

2. 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 reaction kinetics.

3. The system of claim 1, wherein the discrimination criteria includes an empirically derived discrimination line.

4. The system of claim 1, wherein the aqueous non-blood sample is a control solution.

5. A method for calculating a discrimination criteria for programming into a test meter for distinguishing between a blood sample and an aqueous non-blood sample, the method comprising the steps of:

(a) calculating an interferent index and a residual reaction index for a plurality of aqueous non-blood samples; and

(b) calculating a discrimination criteria based on a regression of the interferent index and the residual reaction index for the plurality of aqueous non-blood samples.

6. The method of claim 5, 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.

7. The method of claim 5, wherein the plurality of aqueous non-blood samples are a plurality of control solutions.

8. A method for distinguishing between a blood sample and an aqueous non-blood 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; and

(d) using the interferent index to distinguish between a blood sample and an aqueous non-blood sample.

9. The method of claim 8, wherein the aqueous non-blood sample is a control solution.