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

• US 10,151,724 B2
• Filed: 11/22/2013
• Issued: 12/11/2018
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: LifeScan IP Holdings, LLC
• Inventors: Chatelier, Ronald C., Hodges, Alastair M.
• Primary Examiner(s): Kaur, Gurpreet
• Assistant Examiner(s): Rosenwald, Steven E
• Application Number:
  US14/087,473
• Publication Number:
  US 20140151244A1
• Time in Patent Office: 1,845 Days
• Field of Search: None
• 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 method for distinguishing between a blood sample and an aqueous non-blood sample using a test meter, the test meter having a processor, the method comprising the steps of:

(a) using the test meter, applying a first test voltage for a first time interval, a second test voltage for a second time interval and a third test voltage for a third time interval for each of a plurality of aqueous non-blood samples applied to representative test strips, each test strip having an electrochemical cell;

(b) using the test meter, calculating a first reference value and a second reference (Y) value for the plurality of aqueous non-blood samples, in which the first reference value is determined by a summation of current values measured by the test meter during the first time interval and the second reference value is determined by a ratio of current values obtained during the second and third time intervals;

(c) using the test meter, calculating a third reference (i_capsum) value based on the first reference value, the third reference value being proportional to a capacitance index, the capacitance index (C_av/C_m) comprising a ratio of a pre-determined average capacitance of electrochemical cells measured when blood samples are loaded into test strips of the same type and an estimated capacitance of the electrochemical cell when the sample is introduced (C_m);

(d) using the test meter, repeating steps (a)-(c) for a plurality of blood samples applied to representative test strips, each test strip having an electrochemical cell;

(e) plotting the third reference value obtained from each of the aqueous non-blood samples and each of the blood samples on a first axis and plotting the second reference value obtained from each of the aqueous non-blood samples and each of the blood samples on a second axis and generating a discrimination line segregating the aqueous non-blood samples from the blood samples;

(f) using the test meter, storing a discrimination relation based on the plotted discrimination line as a discrimination criteria;

(g) applying an unknown sample to a test strip;

(h) loading the sample into the test meter;

(i) using the test meter, applying the first test voltage for the first time interval, the second test voltage for the second time interval and the third test voltage for the third time interval;

(j) measuring the capacitance of the unknown sample during the second time interval;

(k) determining the capacitance index of the unknown sample; and

(l) calculating the first reference value, the second reference value and the third reference value for the unknown sample and using the stored discrimination criteria to distinguish whether the unknown sample is a blood sample or an aqueous non-blood sample.

2. The method of claim 1, wherein the first reference value is representative of antioxidant concentration and the second reference value is representative of reaction kinetics.

3. The method of claim 1, wherein the plurality of aqueous non-blood samples comprise a plurality of control solutions.

4. The method of claim 1, wherein the discrimination criteria is applied as follows:

If

5. The method of claim 1, in which the first, second and third test voltages are DC voltages and in which the capacitance of the electrochemical cell is estimated by applying an alternating AC wave during the second time interval with the second test voltage, and either summing the test current over one quarter of the alternating AC wave on either side of the zero crossing point or summing the test currents on either side of the maximum AC component of the current.