GLUCOSE TEST STRIP WITH INTERFERENCE CORRECTION

• US 20160187291A1
• Filed: 12/31/2015
• Published: 06/30/2016
• Est. Priority Date: 12/31/2014
• Status: Abandoned Application

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Estevez-Labori, Francisco, Mayhook, Savanna, Pasqua, John
• Application Number:
  US14/985,830
• Publication Number:
  US 20160187291A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A test strip comprising a base layer, the base layer having an optional hematocrit anode configured to determine a value corresponding to a hematocrit level of a fluid sample, wherein the hematocrit anode may be coated with a reagent, an interference anode configured to determine a value corresponding to a measurement of an interference caused by one or more oxidizable substances in the sample fluid, wherein the interference anode electrode includes an interference reagent on its surface, a glucose anode, the glucose anode being configured to determine a glucose level in the fluid sample, wherein the glucose anode is covered with a reagent comprising a mediator and an analyte specific enzyme, and one or more cathodes in a cooperative relation with the hematocrit anode, the interference anode, and the glucose anode to measure the hematocrit level, the interference and the glucose level.

Claims

1. A test strip comprising:

a base layer;

a hematocrit anode disposed on the base layer and configured to determine a value corresponding to a hematocrit level of a fluid sample, wherein the hematocrit anode is free of a reagent;

an interference anode disposed on the base layer and configured to determine a value corresponding to a measurement of an interference caused by one or more oxidizable substances in the sample fluid, wherein the interference anode electrode includes an interference reagent on its surface;

a glucose anode disposed on the base layer, the glucose anode being configured to determine a glucose level in the fluid sample, wherein the glucose anode is covered with a reagent comprising a mediator and an analyte specific enzyme; and

one or more cathodes in a cooperative relation with the hematocrit anode, the interference anode, and the glucose anode to measure the hematocrit level, the interference and the glucose level.

2. The test strip of claim 1, wherein the strip further comprises a proximal end closer to the fluid sample, and an opposing distal end, and wherein the hematocrit anode is most proximal, the glucose anode is most distal, and the interference anode is positioned between the hematocrit anode and the glucose anode.

3. The test strip of claim 1, wherein the one or more cathodes comprises a hematocrit cathode, an interference cathode, and a glucose cathode, all of which are disposed on the base layer in close proximity to the hematocrit anode, the interference anode and the glucose anode respectively.

4. The test strip of claim 1, wherein the one or more cathodes comprises a hematocrit cathode and a second cathode, wherein the second cathode is shared by the interference anode and the glucose anode.

5. The test strip of claim 1, wherein the one or more cathodes is a single cathode shared by the hematocrit anode, the interference anode, and the glucose anode, the single cathode having a full reagent deposited on upon its surface, and wherein the hematocrit level is measured before the measurement of interference or the determination of the glucose level.

6. The test strip of claim 1, wherein the mediator is potassium ferricyanide or ruthenium hexaammine, and wherein the analyte specific enzyme is glucose oxidase or glucose dehydrogenase.

7. The test strip of claim 1, wherein the one or more cathodes comprises a hematocrit cathode, the test strip having a measurement path between the hematocrit anode and the hematocrit cathode of from about 0.5 mm to about 5 mm.

8. The test strip of claim 7, wherein the hematocrit anode and the hematocrit cathode are separated by an electrically isolated region.

9. The test strip of claim 1, wherein a surface of the interference cathode further comprises a reagent containing an analyte specific enzyme.

10. The test strip of claim 1, wherein the hematocrit anode is shared with a drop detect anode, the shared anode being located at a proximal end of the strip, wherein a drop detect cathode is shared with the glucose cathode and the interference cathode, and wherein the strip further comprises at least one isolation island configured to separate regions of reagents from regions of no reagent.

11. The test strip of claim 1, further comprising at least one hog out region.

12. The test strip of claim 1, further comprising one or more isolation islands, the isolation islands configured to separate regions of the strip with a reagent from regions of the strip without a reagent, or to separate regions of the strip with a reagent from regions of the strip with a different reagent.

13. The test strip of claim 1, further comprising at least one reagent well and a multi-well spacer in which a reagent is drop dispensed.

14. The test strip of claim 1, wherein the hematocrit anode is most proximal, the glucose anode is most distal, and the interference anode is positioned between the hematocrit anode and the glucose anode.

15. A system for measuring glucose concentration comprising:

a test strip comprising a base layer;

a hematocrit anode disposed on the base layer and configured to determine a value corresponding to a hematocrit level of the fluid sample, wherein the hematocrit anode is free of a reagent;

an interference anode disposed on the base layer and configured to determine a value corresponding to a measurement of an interference caused by one or more oxidizable substances in the sample fluid, wherein the interference anode electrode includes an interference reagent on its surface;

a glucose anode is disposed on the base layer, the glucose anode electrode is configured to determine a glucose level in the fluid sample; and

one or more cathodes in a cooperative relation with the anodes to measure hematocrit level, interference and glucose level; and

a test meter configured to accept the test strip, the test meter configured to apply a voltage between the anodes and the one or more cathodes, measure current corresponding to hematocrit level, glucose level and interference, and determine a glucose concentration based on the detected currents.

16. The system of claim 15, wherein the test strip further comprises at least one hog out region.

17. The system of claim 15, wherein the test strip further comprises one or more isolation islands, the isolation islands configured to separate regions of the strip with a reagent from regions of the strip without a reagent, or to separate regions of the strip with a reagent from regions of the strip with a different reagent.

18. A method for measuring an amount of glucose in a sample of blood comprising:

measuring a hematocrit value in a sample of blood placed onto a test strip, wherein the test strip comprises a base layer;

a hematocrit anode disposed on the base layer and configured to determine a value corresponding to a hematocrit level of the fluid sample, wherein the hematocrit anode is free of a reagent;

an interference anode disposed on the base layer and configured to determine a value corresponding to a measurement of an interference caused by one or more oxidizable substances in the sample fluid, wherein the interference anode electrode includes an interference reagent on its surface;

a glucose anode is disposed on the base layer, the glucose anode electrode is configured to determine a glucose level in the fluid sample; and

one or more cathodes in a cooperative relation with the anodes to measure hematocrit level, interference and glucose level;

measuring an amount of glucose in the sample;

determining an amount of interference from one or more interferents present in the sample; and

calculating, with the meter, a final glucose value in the sample by adjusting the measured amount of glucose with both the measured hematocrit value and the determined amount of interference.

19. The method of claim 18, wherein the hematocrit value is measured by applying a voltage with the meter to a pair of hematocrit electrodes;

wherein the amount of glucose is measured by applying a voltage with the meter to a pair of glucose electrodes; and

wherein the amount of interference is determined by applying a voltage with the meter to a pair of interference electrodes.

20. The method of claim 18, wherein the test strip is inserted into a test meter, the test meter being configured to accept the test strip, the test meter configured to apply a voltage between the anodes and the one or more cathodes, measure current corresponding to hematocrit level, glucose level and interference, and determine a glucose concentration based on the detected currents.