Biosensor System Having Enhanced Stability and Hematocrit Performance

An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:

• a base;
• a first electrode on the base including a first conductor and a first reagent layer, the first reagent layer including a mediator having a deposition density of at most 5 g/mm2 and an enzyme system having a deposition density of at most 0.5 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.

An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:

• 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 2 μg/mm2 and an enzyme system having a deposition density of at most 0.5 μg/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.

An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:

• 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 5 μg/mm2 and an enzyme system having a deposition density of at most 0.5 μg/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.

An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:

• 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 2 μg/mm2 and an enzyme system having a deposition density of at most 0.5 μg/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.

An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor 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 5 μg/mm2 of a mediator, and an enzyme system at a deposition density of at most 0.5 μg/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.

An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor 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 2 μg/mm2 of a mediator, and an enzyme system at a deposition density of at most 0.8 μg/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.

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

• applying the fluid sample to an electrochemical biosensor, the biosensor including a base, a first electrode, a second electrode and a lid, the 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 μg/mm2 and an enzyme system having a deposition density of at most 0.8 μg/mm2, the second electrode on the base, the lid and the base assisting in forming an opening to receive the fluid sample;
• applying a pulse sequence to the sample;
• 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.