Accurate analyte measurements for electrochemical test strip based on multiple calibration parameters

• US 10,371,660 B2
• Filed: 05/17/2013
• Issued: 08/06/2019
• Est. Priority Date: 05/17/2013
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: LifeScan IP Holdings, LLC
• Inventors: Malecha, Michael
• Primary Examiner(s): Kaur, Gurpreet
• Assistant Examiner(s): Rosenwald, Steven E
• Application Number:
  US13/896,986
• Publication Number:
  US 20140339100A1
• Time in Patent Office: 2,272 Days
• 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 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

Various embodiments for systems and methods that allow for a more accurate analyte concentration with a biosensor by obtaining two calibration codes, one for batch calibration due to manufacturing variations and the other for time calibration due to measured physical characteristics of the fluid sample.

Claims

1. A method for determining a glucose concentration of a fluid sample applied to a biosensor from a lot of biosensors, the lot of biosensors being calibration coded with a timing calibration code and a batch calibration code, wherein the calibration codes are selected to improve glucose concentration measurements as compared to referential data, the method comprising the steps of:

applying an input signal to at least one electrode of the biosensor;

contacting fluid sample with the at least one electrode;

initiating a test measurement sequence only when an output signal from the electrode is above a predetermined threshold;

obtaining a timing calibration code of the biosensor, the timing calibration code being for determining when to start sampling the output signal and correlated to a time multiplier factor and a time additive component;

determining a particular time point during the test sequence based on the time multiplier factor and the time additive component of the timing calibration code in order to select output signals measured proximate the particular time point;

sampling or measuring output signals from the start of the test sequence;

extracting an output signal proximate the determined particular time point;

obtaining a batch calibration code of the biosensor based on manufacturing variations thereof; and

calculating an analyte concentration from the extracted output signal at the particular time point and the batch calibration code.

2. The method according to claim 1, further comprising:

measuring a hematocrit level of the sample; and

using the measured hematocrit level, determining a specified sampling time;

using the timing calibration code, the specified sampling time and a predetermined nominal sampling time to determine the particular time point.

3. The method according to claim 2, wherein the particular time point is obtained using the relationship t_c=(t_u−

t_n)y₁+y₂+t_n, wherein

t_c is the particular time point;

t_u is the specified sampling time;

t_n is the predetermined nominal time;

y₁ is the time multiplier factor obtained from the timing calibration code; and

y₂ is the time additive component obtained from the timing calibration code, in which the predetermined nominal time is 2.5 seconds from the initiation of the test measurement.

4. The method according to claim 2, wherein the hematocrit level of the sample is determined from an impedance characteristic.

5. The method according to claim 1, in which the method further comprises:

obtaining a slope multiplier and an intercept multiplier from the batch calibration code;

determining the glucose concentration using the slope multiplier, the intercept multiplier and the output signal at the particular time point.

6. The method according to claim 3, wherein the obtaining of the timing calibration code comprises transmitting of the time multiplier factor and the time additive component from one of a storage container for the biosensor or the biosensor itself to a test meter.

7. The method according to claim 5, wherein the obtaining of the batch calibration code comprises transmitting of the slope multiplier and the intercept multiplier from one of a storage container for the biosensor or the biosensor itself to a test meter.