In the United States, more than 1 in 5 people with diabetes do not know they have diabetes, and they are at higher risk of severe health complications by diabetes management failure. Early diagnosis and management of diabetes through HbA1c monitoring can address these public health issues, but many people still do not benefit from the HbA1c test due to its limited accessibility. Alternatively, a portable HbA1c meter, which lay users can easily use, could be a valuable solution to monitor their HbA1c levels without visiting the doctor. However, the current HbA1c test requires precise sample volume and temperature-sensitive maintenance, reducing its usability for lay users.

In this study, as a solution for portable HbA1c meters, we proposed a new HbA1c assay that can be free from sampling error and maintenance by estimating RBC deformability. This novel system employed a microfluidic channel, evaluating RBCs deformability via detecting the velocity of individual RBCs in a fluidic channel with a narrower width than RBC. The results showed that RBC deformability was inversely correlated with HbA1c level and successfully converted the HbA1c level from estimated RBC deformability data. In conclusion, RBC deformability-based HbA1c test has the potential to revolutionize the HbA1c test assay and could benefit individuals beyond the limits of current point-of-care devices.

Disclosure

E.Park: Board Member; Orange Biomed Ltd., Co. S.Kang: Board Member; Orange Biomed Ltd., Co. U.Ko: Board Member; Orange Biomed Ltd., Co.

Funding

Orange Biomed Ltd., Co.

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