METHOD FOR DETERMINING THE CONCENTRATION OF AN ANALYTE IN A LIQUID SAMPLE USING SMALL VOLUME SAMPLES AND FAST TEST TIMES

• US 20170248538A1
• Filed: 05/17/2017
• Published: 08/31/2017
• Est. Priority Date: 11/16/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
• Inventors: Wilsey, Christopher D.
• Granted Patent: US 10,386,322 B2
• Time in Patent Office: Days
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction

Abstract

Analytes in a liquid sample are determined by methods utilizing sample volumes from about 0.3 μl to less than 1 μl and test times from about 3.5 to about 6 seconds after detection of the sample. The methods are preferably performed using small test strips including a sample receiving chamber filled with the sample by capillary action.

Claims

1. A method of analyzing an analyte in a biological fluid sample, the method comprising:

providing an electrochemical sensor comprising;

a flexible substrate;

a conductive pattern disposed on the flexible substrate, the conductive pattern comprising;

an interdigitated array comprising first and second electrodes electrically isolated from each other, each of the first and second electrodes comprising a plurality of electrode elements electrically connected to a common element, each plurality of electrode elements comprising from about 4 to about 30 electrode elements;

first and second pads and first and second connectors electrically connecting the first and second pads to the first and second electrodes, respectively;

wherein each electrode element comprises substantially the same width between about 15 micrometers and about 50 micrometers, and wherein the electrode elements of the first electrode are spaced substantially equally from the electrode elements of the second electrode by a gap having a distance from about 15 micrometers to about 50 micrometers;

a chemical coating disposed over at least a portion of the first electrode, the chemical coating configured for reacting with an analyte to produce an electroactive reaction product; and

a capillary chamber overlying at least a portion of the interdigitated array and configured to direct flow of a biological fluid sample into contact the chemical coating on the first electrode, the capillary chamber having a volume from about 250 nanoliters to about 400 nanoliters;

contacting the capillary chamber with a biological fluid sample, the capillary chamber directing the biological fluid sample into contact with the first and second electrodes and the chemical coating to at least partly solubilize or hydrate the chemical coating,

detecting the contacting of the first and second electrodes by the biological fluid sample and starting a delay period of about 2 to about 6 seconds allowing the analyte and chemical coating to react and to produce electroactive reaction product;

after the delay period, starting an assay period by applying an assay potential across the first and second electrodes for inducing an assay current across the electrodes resulting from oxidation of the electroactive reaction product at one of the first and second electrodes, the assay current reaching a steady-state current;

measuring a magnitude of the assay current during the assay period after the assay current has reached the steady-state current, the measuring step being performed from about 0.5 seconds to about 3 seconds after the start of the assay period; and

correlating the magnitude of the assay current to a concentration of the analyte in the biological fluid sample.

2. The method of claim 1, wherein the number of electrode elements of the first electrode is within 1 of the number of electrode elements of the second electrode.

3. The method of claim 1, wherein the total area of the electrode elements exposed within the capillary chamber is from about 0.1 to about 0.5 square millimeters.

4. The method of claim 1, wherein the biological fluid sample comprises whole blood, and the analyte comprises glucose.

5. The method of claim 1, wherein the measuring step is performed at a fixed assay period point during the assay period, and wherein the magnitude of the assay current at the fixed assay period point correlates generally linearly with the concentration of the analyte over a range of concentrations.

6. The method of claim 5, wherein the biological fluid sample comprises whole blood, the analyte comprises glucose, and the concentration range comprises from about 0 to about 600 mg/dL.