Diagnostic system for hemoglobin analysis
Inventors
Gurkan, Umut • FRAIWAN, ARWA • Galen, Peter
Assignees
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Publication Number
US-12515222-B2
Publication Date
2026-01-06
Expiration Date
Abstract
A diagnostic system detects and/or measures hemoglobin variants in blood of subject, such as HbA1c, to determine blood glucose concentration in the subject.
Core Innovation
The invention relates to a point-of-care diagnostic system and a cartridge electrophoresis device for detecting hemoglobin in a patient sample and separating hemoglobin types. The cartridge includes a microchannel extending between first and second buffer pools, and each buffer pool contains a buffer solution exhibiting an affinity to non-glycosylated hemoglobin. An electrophoresis strip is positioned within the microchannel and receives at least a portion of the patient sample, with first and second ends in the first and second buffer pools in fluid communication with the respective buffer solutions.
The cartridge further includes a first electrode exposed to the buffer solution in the first buffer pool and a second electrode exposed to the buffer solution in the second buffer pool. The first and second electrodes generate an electric field across the electrophoresis strip, inducing migration and separation of one or more bands of hemoglobin types in the patient sample.
The diagnostic system includes band detection and downstream processing to determine diagnostic results from the separated hemoglobin bands. An electrophoresis band detection module detects electrophoresis bands corresponding to hemoglobin types on the electrophoresis strip and generates band detection data, and a processor receives the band detection data, determines band characteristics for the hemoglobin types, and generates diagnostic results, including a diabetes risk-factor determination based on the band characteristics.
Claims Coverage
The independent claim coverage centers on one inventive feature: a diagnostic cartridge that performs electrophoresis-based separation of hemoglobin types using a microchannel, affinity buffer pools for non-glycosylated hemoglobin, and electrodes that apply an electric field to induce migration and band separation. Dependent claims add band detection, processor-based characterization and diagnostic results, determination of a diabetes risk factor, optional specified hemoglobin types, and quantitative constraints on sample volume.
Affinity microchannel electrophoresis cartridge for hemoglobin band separation
A cartridge for a diagnostic system for detecting hemoglobin in a patient sample, comprising a microchannel extending between first and second buffer pools with buffer solutions exhibiting an affinity to non-glycosylated hemoglobin; an electrophoresis strip positioned within the microchannel and structured to receive at least a portion of the patient sample, with first and second ends in the first and second buffer pools, respectively, and in fluid communication with the buffer solution in the respective buffer pools; first and second electrodes exposed to the buffer solutions in the respective buffer pools; and generation of an electric field across the electrophoresis strip inducing migration and separation of one or more bands of hemoglobin types.
Across the provided independent-claim portion, the key inventive coverage is the electrophoresis cartridge architecture: a microchannel between affinity buffer pools for non-glycosylated hemoglobin, an electrophoresis strip spanning the pools, and electrodes generating an electric field to induce migration and separation of hemoglobin-type bands, optionally followed by band detection and processor-based diagnostic result generation.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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