Multi-Path Test Sensor for Undiluted Blood HbA1c Analysis
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Solution Overview
Problem
Current methods for measuring glycated hemoglobin (HbA1c) in blood samples are often inaccurate and labor-intensive, requiring pretreatment or dilution, which limits their availability and accuracy compared to electrochemical systems.
Innovation Solution
A multi-analysis path test sensor system that analyzes undiluted blood samples without pretreatment, using a combination of electrical conductors and chemical reaction zones to determine hematocrit, total hemoglobin, and glycated hemoglobin concentrations, while immobilizing or deactivating interfering reagents to enhance accuracy and efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional clinical laboratory assays are used for HbA1c measurement, then measurement capability is provided, but the process is labor-intensive and time-consuming
Solution Approach 1:
The patent replaces traditional mechanical and chemical separation methods (centrifugation, filtration, manual handling) with a microfluidic integrated system that uses capillary forces, pressure gradients, and on-chip reagent delivery to achieve rapid HbA1c measurement in undiluted blood samples
Solution Approach 2:
The patent divides the complex HbA1c measurement process into separate functional modules within a microfluidic device: sample introduction, hemolysis, HbA1c detection, and interference removal, allowing parallel processing and reducing total analysis time
2Measurement precision
If pretreatment or dilution of blood samples is performed, then measurement accuracy is improved, but device complexity and labor requirements increase
Solution Approach 1:
The patent performs hemolysis and interference removal actions in advance within the microfluidic device before the actual HbA1c measurement, ensuring accurate results from undiluted blood samples without requiring external pretreatment steps
Solution Approach 2:
The patent introduces specific reagents and microfluidic channels as intermediaries to facilitate the separation and detection of HbA1c from other blood components, enabling accurate measurement without manual sample preparation
3Measurement precision
If optical systems with reflectance are used for HbA1c measurement, then measurement capability is provided, but accuracy is reduced compared to electrochemical systems
Solution Approach 1:
The patent replaces optical reflectance measurement with electrochemical detection methods that use electrode reactions to quantify HbA1c, providing superior accuracy and precision in measuring glycated hemoglobin concentrations
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables rapid and accurate determination of glycated hemoglobin concentrations in undiluted blood samples, improving upon the limitations of traditional methods by providing a more efficient and precise electrochemical analysis.
Implementation Method 1
a total hemoglobin analysis path in fluid communication with the common flow inlet, the hemoglobin analysis path including a total hemoglobin working and counter electrode pair arranged in the second isolated flow path; and a glycated hemoglobin analysis path in fluid communication with the common flow inlet, the glycated hemoglobin analysis path including a second chemical reaction zone, a pH adjustment zone, and a glycated hemoglobin working and counter electrode pair arranged in the third isolated flow path
Data Source
AI summary
Electrochemical test sensors and analysis methods are described that reduce or eliminate the pre-treatment or dilution of blood samples prior to HbA1c analysis. Thus, a blood sample obtained from a blood draw or phlebotomy may be introduced to the electrochemical test sensor for HbA1c analysis. The described test sensors immobilize or deactivate incompatible reagents, enzymes, and antibodies so they do not substantially interfere with each other during the analysis. The test sensors also use heat to catalyze reactions that otherwise would proceed at too slow of a rate to be practical.