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-12174202-B2
Publication Date
2024-12-24
Expiration Date
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.
Core Innovation
The invention relates to electrochemical point-of-care determination of hemoglobin parameters from a single blood sample. The sampler includes a pre-analytical solution that lyses red blood cells, oxidizes free hemoglobin to Fe3+, and cleaves FVH (fructosyl-valine-histidine) from free hemoglobin to form an electrochemical test solution.
A first test strip includes a reaction chemistry comprising fructosyl peptide oxidase (FPOX) and a reduced ruthenium mediator, configured to receive the electrochemical test solution for electrochemical determination of A1C. A second test strip includes a reaction chemistry comprising fructosyl peptide oxidase and ferrocyanide, configured to receive the electrochemical test solution for electrochemical determination of total hemoglobin.
The measured A1C and total hemoglobin are combined to derive %HbA1C. The disclosed system architecture includes a sampler and first and second test strips for point-of-care analysis.
Claims Coverage
The independent claim defines a system for determining A1C and total hemoglobin using a sampler pre-analytical solution that produces a shared electrochemical test solution for two distinct electrochemical test strips, for a total of three core inventive features.
Sampler pre-analytical solution forming an electrochemical test solution
A sampler including a pre-analytical solution comprising components for lysing red blood cells, oxidizing free hemoglobin to Fe3+, and cleaving FVH (fructosyl-valine-histidine) from free hemoglobin to form an electrochemical test solution.
First test strip for electrochemical A1C determination using FPOX and reduced ruthenium mediator
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.
Second test strip for electrochemical total hemoglobin determination using FPOX and ferrocyanide
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.
The inventive coverage centers on preparing a shared electrochemical test solution, determining A1C on a first strip using FPOX with a reduced ruthenium mediator, and determining total hemoglobin on a second strip using FPOX with ferrocyanide, with the system configured to enable derivation of %HbA1C from the two measurements.
Stated Advantages
Documented Applications
No documented applications found
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