Systems and methods for electrochemical point-of-care detection of hemoglobin
Inventors
Smith, Donnie • Werner, Brittney L. • Hughes, Gary L. • Chen, Jie
Assignees
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Publication Number
US-11693016-B2
Publication Date
2023-07-04
Expiration Date
Abstract
A method for determining analytes 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. In one aspect, 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. In another aspect, 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.
Core Innovation
The invention provides a method for electrochemically detecting free hemoglobin in a sample solution. The method oxidizes free hemoglobin and cleaves fructosyl-valine-histidine (FVH) from the free hemoglobin to form an electrochemical test solution comprising a mixture of hemoglobin, FVH, and hemoglobin degradation products.
A first portion of the electrochemical test solution is reacted with a chemistry including 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, where the measured electrical property is indicative of an amount of hemoglobin A1C in the sample solution.
A second portion of the electrochemical test solution is reacted with a chemistry including fructosyl peptide oxidase and ferrocyanide to form a second reaction product. A second electrical property of the second reaction product is measured, where the measured electrical property is indicative of an amount of total hemoglobin in the sample solution; the amounts of hemoglobin A1C and total hemoglobin are determined based on the measured first and second electrical properties, respectively, and % HbA1C may be determined based on the determined amounts.
Claims Coverage
The independent claim is directed to an electrochemical detection method that identifies both hemoglobin A1C and total hemoglobin by using two different reaction chemistries and measuring two corresponding electrical properties. The claim contains five inventive feature areas.
Oxidizing and FVH cleavage to form an electrochemical test solution
Oxidizing free hemoglobin and cleaving fructosyl-valine-histidine (FVH) from the free hemoglobin to form an electrochemical test solution comprising a mixture of hemoglobin, FVH, and hemoglobin degradation products.
First reaction with fructosyl peptide oxidase and reduced ruthenium mediator
Reacting a first portion of the electrochemical test solution with a chemistry including fructosyl peptide oxidase and a reduced ruthenium mediator to form a first reaction product.
First electrical property indicative of hemoglobin A1C
Measuring a first electrical property of the first reaction product, the first electrical property being indicative of an amount of hemoglobin A1C in the sample solution.
Second reaction with fructosyl peptide oxidase and ferrocyanide
Reacting a second portion of the electrochemical test solution with a chemistry including fructosyl peptide oxidase and ferrocyanide to form a second reaction product.
Second electrical property indicative of total hemoglobin and determination of analyte amounts
Measuring a second electrical property of the second reaction product, the second electrical property being indicative of an amount of total hemoglobin in the sample solution; determining the amounts of hemoglobin A1C and total hemoglobin based on the measured first and second electrical properties, respectively, and optionally determining % HbA1C based on the determined amounts.
Claim coverage centers on a two-branch electrochemical workflow from an electrochemical test solution generated by oxidizing free hemoglobin and cleaving FVH. The first branch uses fructosyl peptide oxidase with a reduced ruthenium mediator and a first electrical measurement indicative of hemoglobin A1C, while the second branch uses fructosyl peptide oxidase with ferrocyanide and a second electrical measurement indicative of total hemoglobin.
Stated Advantages
Documented Applications
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