Systems and methods of discriminating control solution from a physiological sample

• US 9,157,110 B2
• Filed: 09/12/2012
• Issued: 10/13/2015
• 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.
• Primary Examiner(s): Noguerola, Alexander
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US13/611,703
• Publication Number:
  US 20130001103A1
• Time in Patent Office: 1,126 Days
• Field of Search: 205/775
• US Class Current: 1/1
• 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 a control solution, 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 current data from the test strip, and data storage containing discrimination criteria for distinguishing a blood sample from a control solution, 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 between the reagent and an introduced liquid, in which the processor is programmed to calculate the interferent index based on a summation of current values measured during a first current transient and to determine the residual reaction index by calculating an absolute ratio involving current values obtained during second and third current transients,

wherein the interferent index represents a first reference value and the residual reaction index represents a second reference value and in which the processor is further programmed to distinguish a blood sample from a control solution by comparing the calculated second reference value to a pre-determined threshold function based on the interferent index.

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

3. A system according to claim 1, wherein the introduced liquid is a control solution if the second reference value is less than the following pre-determined threshold function:

4. A system according to claim 1, in which the processor is programmed to compare the calculated first reference value to a pre-determined threshold and then depending on the results of the first reference value comparison, the processor is further programmed to calculate the second reference value and compare the calculated second reference value to the pre-determined threshold function.

5. A system according to claim 4, wherein the pre-determined threshold is about 10 microamperes.