Systems and methods for electrochemical point-of-care detection of hemoglobin

Patent metadata

Field	Value
Publication number	US-12174202-B2
Application number	US-202318328942-A
Country	US
Kind code	B2
Filing date	Jun 5, 2023
Priority date	Nov 29, 2018
Publication date	Dec 24, 2024
Grant date	Dec 24, 2024

Abstract

A method includes lysing the red blood cells of a whole blood sample, oxidizing the free hemoglobin in the lysed sample, and cleaving FVH from the hemoglobin A1C to form an electrochemical test solution. A first portion of the electrochemical test solution is reacted with fructosyl peptide oxidase and a reduced ruthenium mediator to form a first reaction product. A first electrical property of the first reaction product is measured, the measurement being indicative of hemoglobin A1C in the blood sample. A second portion of the electrochemical test solution is reacted with ferrocyanide to form a second reaction product. A second electrical property of the second reaction product is measured, the measurement being indicative of total hemoglobin in the blood sample. Hemoglobin A1C, total hemoglobin, and % HbA1C are determined based on the first and second electrical properties. Also provided are systems and components useful in performing the disclosed methods.

First claim

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

1. A system for the determination of A1C and total hemoglobin comprising:
a sampler including a pre-analytical solution comprising components for lysing red blood cells, oxidizing free hemoglobin to Fe +3 , and cleaving FVH (fructosyl-valine-histidine) from free hemoglobin to form an electrochemical test solution;
a first test strip including a reaction chemistry comprising fructosyl peptide oxidase and a reduced ruthenium mediator for electrochemical determination of A1C, configured to receive the electrochemical test solution; and
a second test strip including a reaction chemistry comprising fructosyl peptide oxidase and ferrocyanide for electrochemical determination of total hemoglobin, configured to receive the electrochemical test solution.

2. The system of claim 1 , wherein the pre-analytical solution includes a Neutral Enzyme Proteinase.

3. The system of claim 1 , wherein the pre-analytical solution includes n-Tetradecyl-N,N-dimethyl-3-ammonio-1-propanesulfonate.

4. The system of claim 1 , wherein the pre-analytical solution includes:
t-Octylphenoxypolyethoxyethanol, Polyethylene glycol tert-octylphenyl ether
880 mM Imidazole;
10 mM NaCl;
3 mM CaCl2;
47.6 mM Tetradecyltrimethylammonium bromide (TTAB);
8.1 mM 1,2-benzoisothiazol-3-one sodium salt; and
35 kU/mL NEP (Neutral Enzyme Proteinase)-801.

5. The system of claim 1 , wherein the pre-analytical solution is configured to be combined with a sample and applied to both the first and second test strip to achieve an analytical result.

Assignees

• Polymer Technology Systems Inc

Inventors

• Smith Donnie
• Werner Brittney L
• Hughes Gary L
• Chen Jie

Classifications

• G01N33/726

  Devices · CPC title

• G01N33/723

  Glycosylated haemoglobin · CPC title

• G01N27/3272

  Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52) · CPC title

• C12N9/50 Primary

  Proteinases {, e.g. Endopeptidases (3.4.21-3.4.25)} · CPC title

• C07K14/805

  Haemoglobins; Myoglobins · CPC title