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Vortex enhanced liquid chromatography for HbA1c monitoring based diabetes management in a globalized setting

Periodic Reporting for period 2 - VortexLC (Vortex enhanced liquid chromatography for HbA1c monitoring based diabetes management in a globalized setting)

Berichtszeitraum: 2023-03-01 bis 2024-08-31

Diabetes is one of the main health risks today with near pandemic dimension, causing blindness, kidney failures, stroke, heart attack, giving rise to very high health care costs (25% in the US) and reducing the quality of life of around 500 million people worldwide. The level of hemoglobin A1c (HbA1c) is used to assess long-term glycemic control and is the best predictor for the risk of developing chronic complication of diabetes and appropriate follow up of the patients. The golden standard is an expert laboratory HPLC method focusing on HbA1c quantification, which has limitations when other relevant hemoglobin variants are to be detected. For approximately 7 % of the world’s population which are carriers of such hemoglobin variants current methods lead to under-, over- or non-estimation of the HbA1c fraction. VortexLC will not only improve the quality of the analysis to give an instant full picture of the health status of diabetes patients, it will also produce a cheap point of care device. The use of vortex flows renders the approach compatible with mass manufacturing of plastic pillar array columns, that are not only much cheaper than commonly used packed bed columns, but wherein also higher separation performances can be obtained. The polymer columns will be fabricated using UV-nanoimprint lithography, plasma technology to make them porous and add a chromatographic coating, and lamination to close the column, all processes that can be scaled to roll-to-roll industrial manufacturing. The columns will be embedded in an instrument that allows for integrated sample preparation and miniaturized UV absorption and SERS detection, allowing for both quantification and identification of analytes. In the project a low footprint demonstrator of the novel system and columns will be built and tested with first synthetic, next human blood samples to quantify Hb1Ac and its genetic variants.
Significant advancements have been achieved in chip fabrication, pattern fidelity, porosification, functional coatings, lamination, and detection technologies. In the development of polymeric chips, resin formulations and imprinting protocols were refined, enabling the creation of intricate structures such as curved walls with undercut features and tapered designs at varying angles. A high level of precision was attained in a small-batch process, achieving an aspect ratio of 4. Porosification efforts led to a substantial increase in surface area, ranging from 150% to 200%. Additionally, two types of functional coatings were successfully applied to imprinted chips. The detection system was effectively miniaturized and seamlessly integrated into a chromatographic column.
We conceived novel concepts and developed new designs and operational methods for analytical separations of Hb, advanced detection, porosification, coating and sample preparation.
Details on results (all beyond the state of the art) are confidential at this stage and will be disclosed after considerations and concomitant actions regarding IP protection.
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