Determination of sample volume adequacy in biosensor devices

• US 7,195,704 B2
• Filed: 08/25/2004
• Issued: 03/27/2007
• Est. Priority Date: 10/10/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Kermani, Mahyar Z., Teodorczyk, Maria, Guo, Sherry X.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/927,176
• Publication Number:
  US 20050023154A1
• Time in Patent Office: 944 Days
• Field of Search: 20440301-40314, 204416-418, 205/775, 205/777.5, 205/778, 205789-7935
• US Class Current: 205/777.5
• 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

Methods and systems are provided for determining whether a volume of biological sample is adequate to produce an accurate electrochemical analyte concentration measurement. Certain such methods and systems provide the additional function of compensating for a sample volume determined to be less than adequate in order to proceed with an accurate analyte concentration measurement. The present invention is employed with a biosensor, such as an electrochemical test strip to which the sample volume of biological solution is deposited, and a meter configured to receive such test strip and to measure the concentration of selected analytes within the biological sample.

Claims

1. A method for compensating for a volume of a biological sample held within an electrochemical biosensor for measurement of at least one characteristic of said biological sample, wherein the sample volume is inadequate for performing said measurement, the method comprising:

measuring the capacitance of the biosensor with the inadequate sample volume; and

determining the ratio of the capacitance of the biosensor filled with an adequate volume of the biological sample to the capacitance of the biosensor with the inadequate sample volume, wherein the capacitance of the biosensor with the adequate volume is known; and

compensating for the inadequate sample volume in order to provide an accurate measurement of the at least one characteristic.

2. The method of claim 1, wherein the step of compensating comprises determining a compensation factor (F_cf) according to the following equation:

F_cf=C_f/C_pf

where C_f is the equivalent capacitance of the electrochemical cell completely filled with the biological sample and C_pf is the equivalent capacitance of the electrochemical cell containing the inadequate volume of biological sample.

3. A method for measuring the concentration of an analyte of a biological sample held within an electrochemical cell, the method comprising:

measuring the analyte concentration (G_pf) wherein it has been determined that the volume of the sample is

inadequate to accurately determine the analyte concentration;

determining a compensation factor (F_cf) according to the following equation;

F_cf=C_f/C_pf

wherein C_f is the equivalent capacitance of the electrochemical cell containing an adequate volume of sample, wherein the equivalent capacitance is previously known, and C_pf is the equivalent capacitance of the electrochemical cell containing the inadequate volume of sample; and

correcting the analyte concentration measurement (G_pf) with the compensation factor (F_cf) according to the following equation;

G=F_cf·

G_pf

where G is the corrected analyte concentration measurement.