Biosensor System Having Enhanced Stability And Hematocrit Performance
First Claim
1. An electrochemical sensor strip for detecting an analyte, comprising:
- a base;
a first electrode on the base having at least one first layer on a first conductor, the first layer including a reagent layer comprising at most 8 μ
g/mm2 of a mediator;
a second electrode on the base;
a lid on the base; and
where the strip provides a determined concentration value having at least one of a stability bias of less than ±
10% after storage at 50°
C. for 2 weeks when compared to a comparison strip stored at 20°
C. for 2 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.
2 Assignments
0 Petitions
Accused Products
Abstract
The present invention relates to electrochemical sensor strips and 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/mm2 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. A method of increasing the performance of a quantitative analyte determination also is provided.
-
Citations
42 Claims
-
1. An electrochemical sensor strip for detecting an analyte, comprising:
-
a base; a first electrode on the base having at least one first layer on a first conductor, the first layer including a reagent layer comprising at most 8 μ
g/mm2 of a mediator;a second electrode on the base; a lid on the base; and where the strip provides a determined concentration value having at least one of a stability bias of less than ±
10% after storage at 50°
C. for 2 weeks when compared to a comparison strip stored at 20°
C. for 2 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. - View Dependent Claims (3, 4, 5, 8, 10, 13, 14, 15, 16, 20, 21, 22, 23, 24)
-
-
2. (canceled)
-
6-7. -7. (canceled)
-
9. (canceled)
- 11. (canceled)
- 17. (canceled)
-
18. (canceled)
-
25. An electrochemical sensor strip for detecting an analyte, comprising:
-
a base; a first electrode on the base having at least one first layer on a first conductor, the first layer including a reagent layer comprising a mediator and an enzyme system, where the reagent layer provides a determined concentration value having at least one of a stability bias of less than ±
10% after storage at 50°
C. for 2 weeks when compared to a comparison strip stored at 20°
C. for 2 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;a second electrode on the base; and a lid on the base.
-
-
26. A method of determining the concentration of an analyte in a sample, comprising:
-
applying a pulse sequence to the sample, the pulse sequence comprising at least 3 duty cycles within 30 seconds; and determining the concentration of the analyte in the sample, 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.
-
-
27-40. -40. (canceled)
-
41. A method of increasing the performance of quantitative analyte determination comprising:
-
introducing an analyte containing sample having a liquid component to an electrochemical sensor strip, the strip having a base, a first conductor on the base, a second conductor on the base, and at least one first layer on at least the first conductor, where the at least one first layer includes a reagent layer including a polymeric binder and the sample provides electrical communication between the first and second conductors; applying an electric potential between the first and second conductors in the form of at least 4 read pulses within 30 seconds; measuring at least one of the read pulses to provide a quantitative value of the analyte concentration in the sample with increased performance attributable to at least one performance parameter selected from the group consisting of a stability bias of less than ±
10% after the strip is stored at 50°
C. for 2 weeks when compared to a comparison strip stored at 20°
C. for 2 weeks, a hematocrit bias of less than ±
10% over a 20 to 60% hematocrit range for whole blood samples, an intercept to slope ratio of at most 10 mg/dL, and combinations thereof.
-
-
42-50. -50. (canceled)
Specification