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Mediator stabilized reagent compositions and methods for their use in electrochemical analyte detection assays

a technology of reagent composition and stabilized reagent, which is applied in the field of electrochemical analyte determination and electrochemical determination of blood analytes, can solve problems such as inaccurate results

Inactive Publication Date: 2008-03-27
LIFESCAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0073] The above results and discussion demonstrate that the present invention provides electrochemical reagent compositions in which the mediator is storage stabilized. Advantages of the subject invention include more accurate results, as well as obviation of the need to include less desirable stabilizing agents and / or perform a burn and read protocol. As such, the subject invention represents a significant contribution to the art.

Problems solved by technology

In such situations, inaccurate results may be obtained when the strip is finally employed because some of the mediator is already reduced.

Method used

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  • Mediator stabilized reagent compositions and methods for their use in electrochemical analyte detection assays
  • Mediator stabilized reagent compositions and methods for their use in electrochemical analyte detection assays
  • Mediator stabilized reagent compositions and methods for their use in electrochemical analyte detection assays

Examples

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Effect test

example 1

Glucose Linearity Results Using Citrate, Malic, and Tartarate

[0068] Citric, malic, and tartaric buffer formulations were separately formulated at 100 mM concentration and pH 5.5. All 3 formulations also contained equivalent amounts of 0.1% anti-foam (RNA Equilibrator), 1 mM CaCl2, PQQ (2× mole ratio to GDH), 200 mM potassium ferricyanide, and 45 mg / mL GDH. Each formulation was ink-jetted onto a Pd substrate. The sensors were tested with blood containing glucose using chronoamperometry by applying a potential of −0.3 V for 10 sec, and then applying a potential of +0.3 V for 5 sec. Testing with blood showed good linearity with glucose for all cases (FIG. 3). Background for citrate and malic buffers were comparable while that of tartaric buffer was higher. In addition, tartaric buffer formed an insoluble salt with Ca2+ making it less desirable.

example 2

Glucose Linearity and Hematocrit Results Using Citrate and Mellitate

[0069] Citrate buffer was formulated at 400 mM and pH 5.5. Mellitate buffer was formulated at 160 mM and pH 6.4. Both formulations also contained equivalent amounts of 0.1% anti-foam (RNA Equilibrator), 1 mM CaCl2, PQQ (2× mole ratio to GDH), 200 mM potassium ferricyanide, and 32 mg / mL GDH. Blood testing was conducted using three hematocrit levels (20, 42, and 70%) and 4 glucose levels (FIGS. 4 and 5). The glucose response was not linear, but did increase with increasing glucose concentration. Hematocrit performance for citrate buffer was slightly better than mellitate. The results are provided in FIGS. 4 and 5.

example 3

Hematocrit and Stability Results Using Citrate and Citraconate

[0070] Citrate and citraconate buffers were separately formulated at 300 mM concentration and pH 6.5. Both formulations also contained equivalent amounts of 0.1% anti-foam (RNA Equilibrator), 4 mM CaCl2, PQQ (2× mole ratio to GDH), 800 mM potassium ferricyanide, and 46 mg / mL GDH. Formulations were deposited on Pd by means of inkjetting. Hematocrit performance for both citrate and citraconate buffers were similar (FIGS. 6 and 7). Accelerated aging at 56° C. for 14 days showed that citraconate had excellent background and performance stability as compared to citrate (Table 1). The bias represented in Table 1 is given as an absolute response difference at the 40 mg / dL glucose concentration, and as a percentage bias for glucose concentration greater than 100 mg / dL.

TABLE 1CITRACONICCITRATEBias to YSIBias to YSIGLUCOSEBias to YSIat Day 14Bias to YSIat Day 14LEVELat Day 0@56 C.at Day 0@56 C.406.985.384.57−7.062406.523.691.44−...

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Abstract

Mediator stabilized reagent compositions and methods for their use in electrochemical analyte determination assays are provided. The subject reagent compositions include an enzyme, a redox mediator and a mediator-stabilizing buffer. Optionally, the reagent compositions may further include one or more of a wetting agent, detergent, enzyme cofactor and combinations thereof. Also provided are electrochemical test strips that include the subject reagent compositions, systems and kits that include the same as well as methods for using the same in analyte detection assays. The subject invention finds use in a variety of different applications, including glucose concentration determination applications.

Description

FIELD OF THE INVENTION [0001] The field of this invention is analyte determination, particularly electrochemical analyte determination and more particularly the electrochemical determination of blood analytes. BACKGROUND [0002] Analyte detection in physiological fluids or samples, e.g., blood or blood derived products, is of ever increasing importance to today's society. Analyte detection assays find use in a variety of applications, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in the diagnosis and management of a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol, and the like. In response to this growing importance of analyte detection, a variety of analyte detection protocols and devices for both clinical and home use have been developed. [0003] One type of method that is employed for analyte detection is an electrochemical method. In such methods, an aqueou...

Claims

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Application Information

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IPC IPC(8): G01N27/26C25B9/00G01N33/483C12Q1/00C12Q1/32C12Q1/54G01N27/327G01N33/66
CPCC12Q1/005C12Q1/004G01N33/66
Inventor TEODORCZYK, MARIACHATELIER, RONALD C.HODGES, ALASTAIR MCINDOEOHARA, TIMOTHY J.DATO, REMY
Owner LIFESCAN INC
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