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US 11,376,590 B2Granted
Diagnostic system for hemoglobin analysis
AssigneeCase Western Reserve University
InventorsUmut Gurkan, Arwa Fraiwan, Peter Galen
Life of this patent
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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.
Claims20
A diagnostic system for detecting hemoglobin, comprising:
- a cartridge including;
- a housing including a microchannel structured to receive a hemolysate of a blood sample, the microchannel extending between first and second buffer pools each containing about 1 μL to about 200 μL of a buffer solution, the buffer solution exhibiting an affinity to non-glycosylated hemoglobin, which facilitates its separation from glycosylated hemoglobin;
- an electrophoresis strip positioned within the microchannel and structured to receive at least a portion of a hemolysate, the electrophoresis strip having first and second ends positioned in the first and second buffer pools so as to be at least partially saturated with the buffer solution in each buffer pool;
- a first electrode connected to the housing and exposed to the buffer solution in the first buffer pool;
- a second electrode connected to the housing and exposed to the buffer solution in the second buffer pool, the first and second electrodes generating an electric field across the electrophoresis strip;
- and
- a sample loading port extending through the housing to the microchannel and providing access to a portion of the electrophoresis strip configured to receive hemolysate of the blood sample, the application of an electric field to the first and second electrodes inducing migration and separation of one or more bands of hemoglobin types in the sample delivered to the electrophoresis strip through the sample loading port;
- a portion of the housing being optically transparent for visualizing the one or more bands of migrated and separated hemoglobin types on the electrophoresis strip.
5 more elements
A diagnostic system for identification and quantification of glycosylated hemoglobin (HbA1c) and non-glycosylated hemoglobin (HbA) in a blood sample, the diagnostic system comprising:
- a cartridge including;
- a housing including a microchannel structured to receive a hemolysate of a blood sample, the microchannel extending between first and second buffer pools each containing about 1 μL to about 200 μL of a buffer solution, the buffer solution exhibiting an affinity to non-glycosylated hemoglobin, which facilitates its separation from glycosylated hemoglobin;
- an electrophoresis strip positioned within the microchannel and structured to receive at least a portion of a hemolysate, the electrophoresis strip having first and second ends positioned in the first and second buffer pools so as to be at least partially saturated with the buffer solution in each buffer pool;
- a first electrode connected to the housing and exposed to the buffer solution in the first buffer pool;
- a second electrode connected to the housing and exposed to the buffer solution in the second buffer pool, the first and second electrodes generating an electric field across the electrophoresis strip;
- and
- a sample loading port extending through the housing to the microchannel and providing access to a portion of the electrophoresis strip configured to receive hemolysate of the blood sample, the application of an electric field to the first and second electrodes inducing migration and separation of bands of HbA1c and HbA in the sample delivered to the electrophoresis strip through the sample loading port;
- a portion of the housing being optically transparent for visualizing the one or more bands of migrated and separated hemoglobin types on the electrophoresis strip;
- an electrophoresis band detection module structured to detect through the optically transparent portion of the housing the HbA1 and HbA bands on the electrophoresis strip caused by the applied electric field and to generate band detection data based on the HbA1c and HbA bands;
- and
- a processor that receives and analyzes the band detection data to determine one or more band characteristics for each of the HbA1c and HbA bands and generate diagnostic results indicative of HbA1c and HbA in the blood sample.
8 more elements
Dependencies are inferred from the claim text.