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 comprisingat most 8 μ
g/mm2 of a mediator, andan enzyme system at a deposition density of at most 0.8 μ
g/mm2;
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.
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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.
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Citations
23 Claims
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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, andan enzyme system at a deposition density of at most 0.8 μ
g/mm2;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 (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification