Electrochemical test strip for reducing the effect of direct and mediated interference current

a technology of direct and mediated interference current and electrochemical test strips, which is applied in the field of electrochemical strips and systems, can solve the problems of unsatisfactory oxidation current, and inability to achieve the effect of reducing the oxidation curren

Inactive Publication Date: 2005-06-30
LIFESCAN SCOTLAND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This design enhances the accuracy of glucose measurements by isolating glucose-specific oxidation currents from interference currents, improving precision and reducing the impact of interfering compounds, even in low glucose concentration ranges and after sterilization processes.

Problems solved by technology

In particular, desirable oxidation current results from the interaction of the mediator with the analyte of interest (e.g., glucose) while undesirable oxidation current is generally comprised of interfering compounds being oxidized at the electrode surface and by interaction with the mediator.
However, this technique is not always successful since some interfering compounds such as acetaminophen do not have a net negative charge, and thus, can pass through a negatively charged membrane.
Nor would this technique reduce the oxidation current resulting from the interaction of interfering compounds with some mediators.
However, such selective membranes typically make the test strip more complicated to manufacture and increase the test time because the oxidized glucose must diffuse through the selective membrane to get to the electrode.
A disadvantage of this strategy is that mediators having a relatively low potential are often difficult to synthesize, unstable and have a low water solubility.
A disadvantage of this strategy is that it requires that the test strip include an additional electrode and electrical connection (i.e., the dummy electrode) which cannot be used to measure glucose.
The inclusion of dummy electrode is an inefficient use of an electrode in a glucose measuring system.

Method used

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  • Electrochemical test strip for reducing the effect of direct and mediated interference current
  • Electrochemical test strip for reducing the effect of direct and mediated interference current
  • Electrochemical test strip for reducing the effect of direct and mediated interference current

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0095] Test strips 800 were prepared as illustrated in FIGS. 1 to 3a. Test strips 800 were tested in blood which were exposed to varying levels of sterilizing radiation. To test strips 800, they were electrically connected to a potentiostat which has the means to apply a constant potential of +0.4 volts between first working electrode 808 and reference electrode 810; and second working electrode 806 and the reference electrode 810. A sample of blood is applied to sample inlet 52 allowing the blood to wick into the sample receiving chamber and to wet first working electrode 808, reference electrode 810, and second working electrode 806. Active layer 820 becomes hydrated with blood and then generates ferrocyanide which may be proportional to the amount of glucose and / or interferent concentration present in the sample. In contrast, inactive layer 818 becomes hydrated with blood and does not generate additional ferrocyanide that was not present within inactive layer 818 before hydration...

example 2

[0096] Two batches of test strips were prepared to show that the use of inactive reagent layer 818 and active reagent layer 820 improved the overall precision for test strips sterilized by gamma radiation. Both batches of test strips were tested in a similar manner as described in Example 1. The first test strip batch is test strip 800 and is referred to as Batch 1. The second test strip batch, which is referred to as Batch 2, is also similar to test strip 800, but does not include inactive reagent layer 818 and also has a modified active reagent layer which covers both first working electrode 808, second working electrode 806, and reference electrode 810. When testing Batch 1, the difference in current from first working electrode 808 and second working electrode 806 was used to calculate a corrected signal current which was then converted to a glucose concentration. When testing Batch 2, the current from second working electrode 806 and first working electrode 808 were summed toge...

example

[0099] Another batch of test strips, which is referred to as Batch 3, was prepared in a manner similar to test strip 800 except that second working electrode 806 was not coated with either active reagent layer 820 or inactive reagent layer 818. In this example, Batches 1 to 3 were tested to evaluate the overall accuracy in the presence of interfering compounds such as uric acid and gentisic acid.

[0100] Batch 1, Batch 2, and Batch 3 test strips were tested in blood at three concentrations of gentisic acid which were 0, 25, and 50 mg / dL. For each gentisic acid concentration, two glucose concentrations were tested which were 70 and 240 mg / dL. FIGS. 16 and 17 show that Batch 1 and Batch 3 test strips had an insignificant change (2 test strips had a significant change (>10 mg / dL or 10%) in bias when testing them at a 25 and a 50 mg / dL gentisic acid concentration. This shows that the use of second working electrode 806 not coated with enzyme allows for an effective correction of the gluc...

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Abstract

The present invention is directed to an electrochemical sensor or electrochemical strip which includes a substrate, a first working electrode disposed on the substrate, a second working electrode disposed on the substrate, a reference electrode, an active reagent layer disposed on the first working electrode, wherein the active reagent layer completely covers the first working electrode and an inactive reagent layer disposed on the second working electrode, wherein the inactive reagent completely covers the second working electrode. The present invention is also directed to an electrochemical sensor an electrochemical sensor including a substrate, a first working electrode disposed on the substrate, a second working electrode disposed on the substrate, a reference electrode, an active reagent layer disposed on the first working electrode, wherein the active reagent layer completely covers the first working electrode, the second working electrode having an active region and an inactive region, the active reagent layer disposed on a active region of the second working electrode and an inactive reagent layer disposed on the inactive region of the second working electrode.

Description

PRIORITY [0001] The present invention claims priority to the following US Provisional Applications: U.S. Provisional Application Ser. No. 60 / 516,252 filed Oct. 31, 2003; U.S. Provisional Application Ser. No. 60 / 558,424 filed Mar. 31, 2004; and U.S. Provisional Application Ser. No. 60 / 558,728 filed Mar. 31, 2004, which applications are hereby incorporated herein by reference. RELATED APPLICATIONS [0002] The present invention is related to the following co-pending US Applications: [0003] U.S. patent application Ser. No. ______ [Attorney Docket Number DDI-5027], filed on Oct. 29, 2004; U.S. patent application Ser. No. ______ [Attorney Docket Number DDI-5042], filed on Oct. 29, 2004; U.S. patent application Ser. No. ______ [Attorney Docket Number DDI-5064], filed on Oct. 29, 2004; U.S. patent application Ser. No. ______ [Attorney Docket Number DDI-5065], filed on Oct. 29, 2004; and U.S. patent application Ser. No. ______ [Attorney Docket Number DDI-5067], filed on Oct. 29, 2004.FIELD OF...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): A61B5/00A61B5/145C12Q1/00G01N27/26G01N27/403G01N27/416G01N27/49G01N33/487G06F19/00
CPCA61B5/1411A61B5/14532G01N27/3274C12Q1/001C12Q1/006A61B5/1486A61B5/150022A61B5/150358A61B5/150282A61B5/150435A61B5/150503Y02A90/10G01N27/416G01N27/49G01N33/487
InventorDAVIES, OLIVER WILLIAM HARDWICKEMARSHALL, ROBERTBASKEYFIELD, DAMIAN EDWARD HAYDONWHYTE, LYSNEYLEIPER, ELAINE
OwnerLIFESCAN SCOTLAND