Systems and methods of discriminating between a control sample and a test fluid using capacitance

• US 8,617,370 B2
• Filed: 09/30/2010
• Issued: 12/31/2013
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Chatelier, Ronald C., Hodges, Alastair M.
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US12/895,067
• Publication Number:
  US 20120080323A1
• Time in Patent Office: 1,188 Days
• Field of Search: 205/775
• US Class Current: 204/406
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: G01N 27/28 Electrolytic cell components
• 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 33/48707 by electrical means G01N33/49, G01N33/493 take precedence

Abstract

Methods for distinguishing between an aqueous non-blood sample (e.g., a control solution) and a blood sample are provided herein. In one aspect, the method includes 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 characteristics of the sample (e.g., amount of interferent present, reaction kinetics, and/or capacitance). The method can also include calculating a discrimination criteria based upon these characteristics. Various aspects of a system for distinguishing between a blood sample 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 programmed to measure and receive electrical current transients from the test strip, and data storage containing discrimination criteria so that a blood sample can be distinguished from an aqueous non-blood sample based on a first reference value, a second reference value, and a capacitance index in which the first reference value is representative of antioxidant concentration and the second reference value is representative of reaction kinetics, each of said first and second reference values employing measured current transients and in which the capacitance index is related to at least one of a measured or predetermined capacitance and the processor is further programmed to calculate a third reference value by multiplying the first reference value by the capacitance index and utilizing the second reference value and the third reference value to determine whether a sample is a blood sample or an aqueous non-blood sample.

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

3. The system of claim 1, wherein the capacitance index comprises a ratio of an average capacitance of electrochemical cells of the same type and a measured capacitance of the electrochemical cell.

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

5. The system of claim 1, wherein the first reference value is multiplied by the capacitance index to derive the third reference value, said capacitance index being a ratio of a known capacitance to a measured capacitance of an electrochemical cell.

6. The system of claim 5, in which the first reference value is a summation of current transients taken over a first time interval.

7. The system of claim 1, wherein the third reference value is represented by the equation