Bayer Healthcare LLC

Ascensia Diabetes Care Holdings Ag

Other

Bayer Corporation

Miles Inc.

Christine D Nelson

Huan-Ping Wu

Eric Anthony Maurer

Hope Spradlin

Andrew J Dosmann

Mary Ellen Warchal-Windham

Greg P Beer

Scott E Carpenter

Frank W Wogoman

Kin-Fai Yip

Lowry J Messenger

Hope G Spradlin

A biosensor has an underfill detection system that determines whether a sample of a biological fluid is large enough for an analysis of one or more analytes. The underfill detection system applies an excitation signal to the sample, which generates an output signal in response to the excitation signal. The underfill detection system switches the amplitude of the excitation signal. The transition of the excitation signal to a different amplitude changes the output signal when the sample is not large enough for an accurate and/or precise analysis. The underfill detection system measures and compares the output signal with one or more underfill thresholds to determine whether an underfill condition exists.

Biosensor for determining a concentration of a biosensor using an underfill procedure

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 &#x3bc;g/mmof 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 &#xb1;10% after storage at 50&#xb0; C. for 4 weeks when compared to a comparison strip stored at &#x2212;20&#xb0; C. for 4 weeks, a hematocrit bias of less than &#xb1;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.

Electrochemical test sensor

Underfill detection system for a biosensor

A biosensor has an abnormal output detection system that determines whether an output signal from the redox reaction of an analyte has a normal or abnormal shape or configuration. The abnormal output detection system improves the accuracy and precision of the biosensor in determining whether an output signal has a shape or configuration that may not provide an accurate and/or precise analysis of a biological fluid. The biosensor generates an output signal in response to the redox reaction of the analyte. The biosensor normalizes the output signal and compares the normalized output signal with one or more control limits. The biosensor may generate an error signal when the normalized output signal is not within the control limits.

Determining analyte concentrations in biological fluids with abnormal output detection

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 &#x3bc;g/mmof 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 &#xb1;10% after storage at 50&#xb0; C. for 4 weeks when compared to a comparison strip stored at &#x2212;20&#xb0; C. for 4 weeks, a hematocrit bias of less than &#xb1;10% for whole blood samples including from 20 to 60% hematocrit, and an intercept to slope ratio of at most 20 mg/dL.

Methods of determining analyte concentration having enhanced stability and hematocrit performance

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Gated amperometric pulse sequences including multiple duty cycles of sequential excitations and relaxations may provide a shorter analysis time and/or improve the accuracy and/or precision of the analysis. The disclosed gated amperometric pulse sequences may reduce analysis errors arising from the hematocrit effect, variance in cap-gap volumes, non-steady-state conditions, mediator background, under-fill, temperature changes in the sample, and a single set of calibration constants.

Gated amperometry methods

A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Temperature-adjusted analyte determination for biosensor systems

Biosensor performance increasing methods having enhanced stability and hematocrit performance

Biosensor methods having enhanced stability and hematocrit performance

Gated amperometry

Abnormal output detection system for a biosensor

A total transmission spectroscopy system for use in determining the analyte concentration in a fluid sample comprises a sample cell receiving area, a light source, a collimating lens, a first lens, a second lens, and a detector. The sample cell receiving area is adapted to receive a sample to be analyzed. The sample cell receiving area is constructed of a substantially optically clear material. The collimating lens is adapted to receive light from the light source and adapted to illuminate the sample cell receiving area with a substantially collimated beam of light. The first lens is adapted to receive regular and scattered light transmitted through the sample at a first angle of divergence. The first lens receives light having a first angle of acceptance. The first lens outputs light having a second angle of divergence. The second angle of divergence is less than the first angle of divergence. The second lens is adapted to receive light from the first lens and adapted to output a substantially collimated beam of light. The detector is adapted to measure the light output by the second lens.

Method of determining glucose concentration of a whole blood sample

Growing community of inventors

Edwardsburg, MI, United States of America

Christine D Nelson