Analysis Techniques for Measuring Glycated Hemoglobin in Undiluted Blood Samples
OwnerJim Connollyinventor
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Abstract
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.
Claims22
A method of determining a corrected glycated hemoglobin concentration of an undiluted whole blood sample, the method comprising:
- introducing an undiluted whole blood sample to a test sensor;
- applying a potential to at least two electrical conductors of a hematocrit flow path;
- determining an output current responsive to a hematocrit content of the sample;
- applying a potential to a total hemoglobin working and counter electrode pair;
- determining an output current from the total hemoglobin working and counter electrode pair responsive to a total hemoglobin concentration of the sample;
- applying a potential to a glycated hemoglobin working and counter electrode pair;
- determining an output current from the glycated hemoglobin working and counter electrode pair responsive to a glycated hemoglobin concentration of the sample;
- and
- determining a corrected glycated hemoglobin concentration of the sample from the output currents, the output currents determined from
- the hematocrit flow path,
- the total hemoglobin working and counter electrode pair, and
- the glycated hemoglobin working and counter electrode pair.
Dependencies are inferred from the claim text.