Method for determination of analyte concentrations and related apparatus

• US 8,591,722 B2
• Filed: 08/09/2011
• Issued: 11/26/2013
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Diamond, Steven, Harding, Ian, Iyengar, Sridhar G., Wei, Baoguo
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US13/206,010
• Publication Number:
  US 20110290673A1
• Time in Patent Office: 840 Days
• Field of Search: 204/400, 20440301-40307, 2044031-40315, 205/775, 205/777.5, 205/792, 600345-347, 600/365, 702/22, 702/23, 702/30, 702/108, 702/116, 73/614.1, 324/713, 324/76.39
• US Class Current: 205/775
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/4161 measuring the voltage and using a constant current supply, e.g. chronopotentiometry
• CPC Class Codes: G01N 27/4166 measuring a particular property of an electrolyte
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence

Abstract

A method is provided for determining analyte concentrations, for example glucose concentrations, that utilizes a dynamic determination of the appropriate time for making a glucose measurement, for example when a current versus time curve substantially conforms to a Cottrell decay, or when the current is established in a plateau region. Dynamic determination of the time to take the measurement allows each strip to operate in the shortest appropriate time frame, thereby avoiding using an average measurement time that may be longer than necessary for some strips and too short for others.

Claims

1. A method for detecting an error condition in an electrochemical determination of an analyte in a sample applied to an electrochemical test strip disposed in an analyte detection apparatus, comprising the steps of:

(a) introducing a sample to be evaluated into an electrochemical test strip having working and counter electrodes;

(b) applying a potential between the electrodes sufficient to generate a diffusion-limited current when analyte is present in the sample;

(c) dynamically determining a time, t_peak, as the time when diffusion limiting current at the counter electrode is established;

(d) comparing the determined value of t_peak to a predetermined range, and returning an error message when the determined value falls outside of the range.

2. The method of claim 1, wherein the sample is a blood sample.

3. The method of claim 2, wherein the electrochemical test strip is a test strip for determination of glucose in the sample.

4. The method of claim 1, wherein the electrochemical test strip is a test strip for determination of glucose in the sample.

5. A meter for receiving an electrochemical test strip having electrodes and providing a determination of an analyte in a sample applied to the electrochemical test strip when received in the meter, said meter comprising

(a) a housing having a slot for receiving an electrochemical test strip;

(b) communications means for receiving input from and communicating a result to a user;

(c) means for determining a time, wherein the means determines the time when diffusion limiting current at the counter electrode is established, referred to as t_peak; and

(d) means for comparing the determined value of t_peak to a predetermined range and returning an error message when the determined value falls outside of the range.