Biosensor system having enhanced stability and hematocrit performance

A technology of hematocrit and stability, which is applied in the direction of microbiology, biological testing, biochemical equipment and methods, etc., and can solve problems such as analysis deviations

Active Publication Date: 2009-08-26
ASCENSIA DIABETES CARE HLDG AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite the potential usefulness of these methods, conventional glucose sensors still show significant analytical bias due to hematocrit effects, typically around 15% to 30%

Method used

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  • Biosensor system having enhanced stability and hematocrit performance
  • Biosensor system having enhanced stability and hematocrit performance
  • Biosensor system having enhanced stability and hematocrit performance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0123] Example 1 : Sensor strip preparation

[0124] In one aspect, the sensor strips of the present invention are made using pin deposition. Counter electrode reagent solutions were prepared by making stock solutions of 100 mM phosphate buffer in 1% carboxymethylcellulose (CMC). Next, enough powdered mediator was dissolved in the buffer / CMC solution to make a final solution of 100 mM mediator in 100 mM phosphate buffer and 1% CMC.

[0125] Working electrode reagent solutions are typically prepared by making a stock solution (eg, 100 mL) of 100 mM phosphate buffer in 0.5% CMC. Next, enough powdered mediator is dissolved in the buffer / CMC stock solution to make a solution of 24-25 mM mediator in 100 mM phosphate buffer and 0.5% CMC (eg, 10 mL). Finally, for an enzyme loading of 5 U / μL, approximately 33.4 mg of the PQQ-GDH enzyme system (749 U / mg specific activity) was combined with 5 mL of mediator / buffer / CMC solution in a glass vessel ([5000 U / mL× 5mL] / [749U / mg]=33.4mg). ...

Embodiment 2

[0127] Example 2 : Donor Research

[0128] Whole blood samples were collected from 21 subjects with diabetes. Each subject was analyzed twice to provide 42 measurements with each of the four sensor strip lots SS1 to SS4 from each of the four sensor strip lots SS1 to SS4 provided in Table III below. Different working and counter electrode reagent compositions were used for SS1 to SS3, while SS4 used a single reagent composition that essentially covered both conductors. SS1, SS2, and SS3 represent different manufacturing lots using the same reagent volume. For SS1 to SS3, the volume of reagent composition deposited on each conductor was about 0.24 μL, and both deposition areas were about 1.5 mm 2 . For SS1, the volume of reagent composition deposited to cover both conductors was about 0.3 μL for a total deposition area of ​​about 3 mm 2 .

[0129] Table III

[0130] Working electrode deposition

Counter electrode deposition

SS1

1.62...

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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 [Mu]g / mm 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 DEG C for 4 weeks when compared to a comparison strip stored at 20 DEG C for 4 weeks, a hematocrit bias of less than +-10% for whole blood samples including from 20 to 60% hematocrit, and a intercept to slope ratio of at most 20 mg / dL. A method of increasing the performance of a quantitative analyte determination also is provided.

Description

[0001] References to related applications [0002] This application claims priority to U.S. Provisional Application No. 60 / 846,688, filed September 22, 2006, entitled "Biosensor System Having Enhanced Stability and Hematocrit Performance" , which is hereby incorporated by reference in its entirety. Background technique [0003] Biosensors provide analysis of biological fluids such as whole blood, urine or saliva. In general, biosensors analyze samples of biological fluids to determine the concentration of one or more analytes in the biological fluid, such as glucose, uric acid, lactate, cholesterol, or bilirubin. Such analysis can be used to diagnose and treat physiological abnormalities. For example, a diabetic patient could use a biosensor to measure glucose levels in whole blood to adjust diet and / or medication. [0004] Biosensors can be implemented using benchtop devices, portable devices, and the like. Portable devices may be hand-held. Biosensors can be designed to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/00G01N33/487G01N27/30
CPCC12Q1/006G01N27/327C12Q1/004Y10S435/817G01N27/3273G01N27/3271G01N27/3272G01N33/49G01N27/3274G01N33/5438
Inventor 伍焕平克里斯廷·D·纳尔森霍普·斯普拉德林埃里克·莫雷尔
Owner ASCENSIA DIABETES CARE HLDG AG
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