IP Library Granted Patent US 9,239,312
Granted Patent B2
US 9,239,312 · App. 14/252,226 · Granted Jan 19, 2016

Methods of determining analyte concentration having enhanced stability and hematocrit performance

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Quick Facts
Patent No.
US 9,239,312
App. No.
14/252,226
Granted
Jan 19, 2016
Kind
B2
Abstract

The present invention relates to methods of determining the concentration of an analyte in a sample or improving the performance of a concentration determination. The electrochemical sensor strips may include at most 8 μg/mm 2 of a mediator. The strips, the strip reagent layer, or the methods may provide for the determination of a concentration value having at least one of a stability bias of less than ±10% after storage at 50° C. for 4 weeks when compared to a comparison strip stored at −20° C. for 4 weeks, a hematocrit bias of less than ±10% for whole blood samples including from 20 to 60% hematocrit, and an intercept to slope ratio of at most 20 mg/dL.

Claims (27)

1. A method of determining the concentration of an analyte in a sample, comprising:

applying a sample to an electrochemical sensor strip, the sensor strip including a first electrode, the first electrode including at least one first layer on a first conductor, the at least one first layer including an enzyme system and at most 8 μg/mm 2 of a mediator,

wherein the mediator assists in transferring electrons between an analyte in the sample and the first conductor;

applying a pulse sequence to the sample, the pulse sequence comprising at least 2 duty cycles within 3 to 14 seconds, wherein the at least 2 duty cycles each comprise an excitation, and the excitations are separated by a relaxation,

wherein the relaxation provides an output current reduction to one-half or less of the current flow at the excitation maxima;

determining current measurements from the sample responsive to the pulse sequence; and

determining the concentration of the analyte in the sample from the current measurements, the determined concentration having at least one of a stability bias of less than ±10%, a hematocrit bias of less than ±10% for whole blood samples over a 20 to 60% hematocrit range, and an intercept to slope ratio of at most 20 mg/dL.

2. The method of claim 1 , wherein the relaxation is from 0.2 to 3 seconds in duration.

3. The method of claim 1 , wherein the relaxation is from 0.5 to 1 second in duration.

4. The method of claim 1 , wherein the excitations of the at least 2 duty cycles have a duration of at most 2 seconds.

5. The method of claim 1 , wherein the excitations of the at least 2 duty cycles have a duration from 0.01 to 3 seconds.

6. The method of claim 1 , wherein the excitations of the at least 2 duty cycles have a duration from 0.75 to 3 seconds.

7. The method of claim 1 , wherein the excitations have a summed duration of at most 10 seconds.

8. The method of claim 1 , wherein the excitations comprise at most 45% of the time of the pulse sequence.

9. The method of claim 1 , wherein the excitations of the at least 2 duty cycles are of different amplitudes.

10. The method of claim 9 , wherein the different amplitudes are within 500 mV.

11. The method of claim 9 , wherein the excitations of the at least 2 duty cycles include one excitation having a greater amplitude than the other excitation.

12. The method of claim 1 , the pulse sequence comprising at least 3 duty cycles within 9 seconds.

13. The method of claim 1 , the pulse sequence comprising at least 3 duty cycles within 30 seconds.

14. The method of claim 1 , wherein the pulse sequence is complete in at most 5 seconds.

15. The method of claim 1 , wherein the determining the concentration of the analyte in the sample includes determining the concentration of the analyte in the sample from a current measurement taken within 2 seconds of applying the pulse sequence.

16. The method of claim 1 , wherein the pulse sequence includes an initial excitation from 0.75 to 3 seconds in duration, wherein the initial excitation is longer in duration than the excitations of the at least 2 duty cycles.

17. The method of claim 1 , wherein the relaxation is responsive to an open circuit.

18. The method of claim 1 , wherein the stability bias is less than ±5%.

19. The method of claim 1 , wherein the stability bias is less than ±5% after the strip is stored at 50° C. for 4 weeks when compared to a comparison strip stored at −20° C. for 4 weeks.

20. The method of claim 1 , wherein the hematocrit bias is less than ±5% for whole blood samples including from 20 to 60% hematocrit.

21. The method of claim 1 , wherein the intercept to slope ratio is at most 10 mg/dL.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2016
From: BAYER HEALTHCARE LLC
To: ASCENSIA DIABETES CARE HOLDINGS AG
Reel/Frame 037880/0604 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2014
From: WU, HUAN-PING; NELSON, CHRISTINE; SPRADLIN, HOPE G.; MAURER, ERIC
To: BAYER HEALTHCARE LLC
Reel/Frame 033375/0527 →