ELECTROCHEMICAL-BASED ANALYTICAL TEST STRIP WITH GRADED ENZYMATIC REAGENT LAYER AND RELATED METHODS
First Claim
1. An electrochemical-based analytical test strip for the determination of an analyte in a bodily fluid sample, the electrochemical-based analytical test strip comprising:
- an electrically-insulating substrate;
at least one working electrode disposed on the electrically-insulating substrate;
a graded enzymatic reagent layer disposed on the at least one working electrode, the graded enzymatic reagent layer including at least;
an upper reaction grade containing at least an enzyme; and
a lower spacer grade devoid of the enzyme, the lower spacer grade disposed between the upper reaction grade and the at least one working electrode such that the upper reaction grade is spaced equidistant from the at least one working layer by the lower spacer grade by a predetermined distance during use of the electrochemical-based analytical test strip, andwherein the upper reaction grade is configured and constituted such that an enzymatic reaction between the enzyme and an analyte in the bodily fluid sample applied to the electrochemical-based analytical test strip is localized within the upper reaction grade; and
wherein the lower spacer grade has predetermined mass transport characteristics for a component of the enzymatic reaction that cause mass transport of the component through the lower spacer grade to the working electrode to be slower than mass transport of the analyte through the bodily fluid sample to the upper reaction grade during use of the electrochemical-based analytical test strip.
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Accused Products
Abstract
An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (e.g., a whole blood sample) includes an electrically-insulating substrate, at least one working electrode disposed on the electrically-insulating substrate and a graded enzymatic reagent layer disposed on the at least one working electrode. The graded enzymatic reagent layer includes an upper reaction grade that contains an enzyme. The graded enzymatic layer also has a lower spacer grade devoid of the enzyme, the lower spacer grade disposed between the upper reaction grade and the working electrode such that the upper reaction grade is spaced equidistant from the working electrode by the lower spacer grade by a predetermined distance during use of the electrochemical-based analytical test strip. In addition, the upper reaction grade is configured and constituted such that an enzymatic reaction between the enzyme and a bodily fluid sample applied to the electrochemical-based analytical test strip is localized in the upper reaction grade and the lower spacer grade has predetermined mass transport characteristics for a component of the enzymatic reaction that cause mass transport of the component through the lower spacer grade to the working electrode to be slower than mass transport of the analyte through the bodily fluid sample to the upper reaction grade. A method for determining an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes applying a bodily fluid sample to such an electrochemical-based analytical test strip.
7 Citations
28 Claims
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1. An electrochemical-based analytical test strip for the determination of an analyte in a bodily fluid sample, the electrochemical-based analytical test strip comprising:
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an electrically-insulating substrate; at least one working electrode disposed on the electrically-insulating substrate; a graded enzymatic reagent layer disposed on the at least one working electrode, the graded enzymatic reagent layer including at least; an upper reaction grade containing at least an enzyme; and a lower spacer grade devoid of the enzyme, the lower spacer grade disposed between the upper reaction grade and the at least one working electrode such that the upper reaction grade is spaced equidistant from the at least one working layer by the lower spacer grade by a predetermined distance during use of the electrochemical-based analytical test strip, and wherein the upper reaction grade is configured and constituted such that an enzymatic reaction between the enzyme and an analyte in the bodily fluid sample applied to the electrochemical-based analytical test strip is localized within the upper reaction grade; and wherein the lower spacer grade has predetermined mass transport characteristics for a component of the enzymatic reaction that cause mass transport of the component through the lower spacer grade to the working electrode to be slower than mass transport of the analyte through the bodily fluid sample to the upper reaction grade during use of the electrochemical-based analytical test strip. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for determining an analyte in a bodily fluid sample, the method comprising:
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applying a bodily fluid sample to an electrochemical-based analytical test strip that includes; at least one working electrode disposed on an electrically-insulating substrate; a graded enzymatic reagent layer disposed on the at least one working electrode, the graded enzymatic reagent layer including at least; an upper reaction grade containing at least an enzyme; and a lower spacer grade devoid of the enzyme, the lower spacer grade disposed between the upper reaction grade and the at least one working electrode such that the upper reaction grade is spaced equidistant from the at least one working electrode by the lower spacer grade by a predetermined distance during use of the electrochemical-based analytical test strip, wherein the upper reaction grade is configured and constituted such that an enzymatic reaction between the enzyme and an analyte in the bodily fluid sample applied to the electrochemical-based analyte test strip is localized within the upper reaction grade, and wherein the lower spacer grade has predetermined mass transport characteristics for a component of the enzymatic reaction that cause mass transport of the component through the lower spacer grade to the working electrode to be slower than mass transport of the analyte through the bodily fluid sample to the upper reaction grade during use of the electrochemical-based analytical test strip; measuring an electrochemical response of the electrochemical-based analytical test strip; and determining the analyte based on the measured electrochemical response. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification