SYSTEM AND METHOD FOR DETERMINING THE CONCENTRATION OF AN ANALYTE IN A SAMPLE FLUID

• US 20130043141A1
• Filed: 10/24/2012
• Published: 02/21/2013
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• 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.
• Granted Patent: US 8,586,373 B2
• Time in Patent Office: Days
• US Class Current: 205/782
• 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 an analyte of interest in a biological sample, comprising:

a) applying a first signal having a first AC component to the sample;

b) measuring a first response to the first signal;

c) applying a second signal having a second AC component to the sample;

d) measuring a second response to the second signal;

e) applying a third signal having a third AC component to the sample;

f) measuring a third response to the third signal;

g) applying a fourth DC signal to the sample;

h) measuring a fourth response to the fourth DC signal; and

e) determining the analyte concentration of the sample using at least the first, second and third responses to correct the fourth response for the effects of at least one interferent within the sample, wherein the determination has a Total Test Time of within about 2.0 seconds or less, and wherein the first, second third, and fourth signals are applied to the sample during separate time periods.

2. The method of claim 1, wherein the determination has a Total Test Time of between about 0.5 seconds and about 1.525 seconds.

3. The method of claim 1, wherein the method has a Total System Error of less than about 11%.

4. The method of claim 1, wherein the biological sample is blood and the analyte of interest is glucose.

5. The method of claim 1, wherein the first, second and third signals each comprise an AC signal, each AC signal having a different frequency, and wherein the fourth signal comprises a DC signal.

6. The method of claim 1, wherein the interferent comprises one or both of hematocrit and temperature.

7. The method of claim 1,

wherein the first signal is applied for no more than about 100 ms before the first response is measured;

wherein the second signal is applied for no more than about 100 ms before the second response is measured; and

wherein the third signal is applied for no more than about 100 ms before the third response is measured.

8. The method of claim 1, wherein the fourth signal is applied for no more than about 200 ms before the fourth response is measured.

9. The method of claim 1, further comprising:

applying a fifth signal having a fourth AC component during a separate time period from the first, second, third and fourth signals; and

measuring a fifth response to the fifth signal;

wherein said determination of the analyte concentration of the sample uses at least the first, second, third and fifth responses to correct the fourth response for the effects of at least one interferent within the sample.

10. The method of claim 9, wherein the first, second, third and fifth signals each comprise an AC signal, each AC signal having a different frequency, and wherein the fourth signal comprises a DC signal.

11. The method of claim 9,

wherein the first signal is applied for no more than about 100 ms before the first response is measured;

wherein the second signal is applied for no more than about 100 ms before the second response is measured;

wherein the third signal is applied for no more than about 100 ms before the third response is measured; and

wherein the fifth signal is applied for no more than about 100 ms before the fifth response is measured.

12. The method of claim 9, wherein the first signal is a 10 kHz AC signal, the second signal is a 20 kHz AC signal, the third signal is a 1 kHz AC signal, and the fifth signal is a 2 kHz AC signal.

13. The method of claim 9, wherein the fourth signal is applied for no more than about 200 ms before the fourth response is measured.

14. The method of claim 9, wherein the method has a Total System Error of less than about 11%.

15. The method of claim 14, wherein the method has a Total System Error of between about 7.5% and about 11%.