Systems and methods for electrochemical hematocrit determination by alternate current impedance phase angle determinations

Patent metadata

Field	Value
Publication number	US-12270780-B2
Application number	US-202318312089-A
Country	US
Kind code	B2
Filing date	May 4, 2023
Priority date	Nov 25, 2014
Publication date	Apr 8, 2025
Grant date	Apr 8, 2025

Abstract

A system for determining a level of hematocrit includes a test strip configured to receive a sample; a meter configured to receive the test strip; and further including circuitry and a microprocessor, the circuitry and microprocessor configured to apply electrical energy to the test strip and the sample and determine an electrical property of the sample, either the impedance phase angle or the impendence magnitude of the test strip and the sample and, based on the electrical property, calculate the level of hematocrit in the sample.

First claim

What is claimed as new and desired to be protected by Letters Patent of the United States is:

1. A method for determining a level of hematocrit, comprising:
providing a system, the system including:
a test strip configured to receive a sample;
a meter configured to receive the test strip and further including circuitry and a microprocessor, the circuitry and microprocessor configured to apply electrical energy to the test strip and the sample and determine an impedance phase angle of the test strip;
receiving a sample at the test strip and inserting the test strip into the meter;
applying a current to the test strip from the meter;
determining a phase angle for the sample using the circuitry and microprocessor;
calculating the level of hematocrit in the sample at the meter based on an amount of glucose in the sample that affects an impedance magnitude and the impedance phase angle at a different rate than the level of hematocrit, a level of glucose and the level of hematocrit; and
providing an output of the level of hematocrit to a user.

2. The method of claim 1 , further comprising
determining, using the circuitry and microprocessor, an impedance of the test strip and the sample.

3. The method of claim 2 , wherein the level of hematocrit is based on both the impedance phase angle and the impedance.

4. The method of claim 3 , further comprising
determining, using the circuitry and microprocessor, a glucose level of the sample.

5. The method of claim 4 , wherein the level of hematocrit determined is based on the interrelationship between impedance and phase angle, wherein the glucose level and the level of hematocrit have disparate but proportional impacts on the impedance and the impedance phase angle, such that the level of each of the glucose level and the level of hematocrit is determinable.

6. The method of claim 5 , wherein the test strip includes a first sample window, the first sample window including a first electrode and a second electrode.

7. The method of claim 6 , wherein the glucose level and the level of hematocrit both are determined from the sample in the single sample window.

8. The method of claim 7 , wherein the single sample window includes a first set of electrodes and a second set of electrodes.

9. The method of claim 8 , wherein the first set of electrodes is configured to test for impedance and the second set of electrodes is configured to test for impedance phase angle.

10. The method of claim 6 , wherein the test strip includes a first sample window and a second sample window, the first sample window including electrodes having a reagent for glucose testing.

Assignees

• Polymer Technology Systems Inc

Inventors

• Hughes Gary L
• Jesswein Ryan D

Classifications

• G01N27/3271

  Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood (amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001) · CPC title

• G01N27/3275

  Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction · CPC title

• G01N27/3277

  being a redox reaction, e.g. detection by cyclic voltammetry (voltammetry per se G01N27/42, G01N27/48) · CPC title

• G01N2496/80

  Multi-analyte reference solutions containing cholesterol, glucose and the like · CPC title

• G01N2333/904

  acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1) · CPC title