System and method for determining the concentration of an analyte in a sample fluid

• US 8,420,404 B2
• Filed: 10/24/2012
• Issued: 04/16/2013
• Est. Priority Date: 06/20/2003
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Diebold, Eric R., Beaty, Terry A., Buck, Harvey B. Jr.
• Primary Examiner(s): Alexander, Lyle
• Application Number:
  US13/659,189
• Publication Number:
  US 20130048512A1
• Time in Patent Office: 174 Days
• Field of Search: 436/68, 436149-151, 422/82.01, 422/82.02
• US Class Current: 436/150
• 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 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

The present disclosure relates to various methods for measuring the amount of an analyte present in a biological fluid using an electrochemical testing process. Various embodiments are disclosed, including the use of AC test signals and the performance of tests having a Total Test Time within about 3.0 seconds or less, and/or having a clinically low Total System Error.

Claims

1. A method for determining a concentration of a medically significant component of a biological fluid sample in contact with a reagent compound, comprising the steps of:

a) applying a signal having an AC component to the biological fluid sample;

b) measuring a response to the signal;

c) determining an interferent correction based on the response; and

d) providing an indication of the concentration of the medically significant component, wherein the indication is corrected using the interferent correction;

wherein said signal comprises a multi-frequency excitation waveform formed by adding a plurality of individual waveforms of varying frequency together so that the fluid sample is excited by multiple frequencies at the same time such that the response contains measurement data collected simultaneously for all of the multiple frequencies.

2. The method according to claim 1, wherein the medically significant component comprises glucose and the biological fluid sample comprises blood.

3. The method according to claim 2, wherein the response comprises information pertaining substantially only to one or both of hematocrit and temperature.

4. The method according to claim 1, wherein the method has a Total System Error of less than about 15%.

5. The method according to claim 1, wherein the multi-frequency excitation waveform comprises at least two frequencies selected from the group consisting of about 1 kHz, about 2 kHz, about 10 kHz and about 20 kHz.

6. The method according to claim 5, wherein measuring the response comprises measuring one or both of admittance and phase information corresponding to each of the frequencies comprising the multi-frequency excitation waveform generally simultaneously.