ELECTROCHEMICAL TEST SENSOR
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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.
2 Citations
74 Claims
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1-50. -50. (canceled)
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51. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a mediator having a deposition density of at most 8 μ
g/mm2 and an enzyme system having a deposition density of at most 0.8 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having a stability bias of less than +/−
10% after storage at 50°
C. for 2 weeks when compared to a comparison biosensor stored at −
20°
C. for 2 weeks. - View Dependent Claims (52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62)
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63. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a mediator having a deposition density of at most 8 μ
g/mm2 and an enzyme system having a deposition density of at most 0.8 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having a hematocrit bias of less than +/−
10% for whole blood samples including from 20 to 60% hematocrit. - View Dependent Claims (64, 65, 66, 67)
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68. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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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, and an enzyme system at a deposition density of at most 0.8 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having an intercept to slope ratio of at most 20 mg/dL. - View Dependent Claims (69, 70, 71, 72, 73, 74)
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Specification