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

Introduction

Diabetes is one of the main health risks today with near pandemic dimensions, causing blindness, kidney failures, stroke, and heart attack. This condition gives rise to very high health care costs (25% in the US) and reduces the quality of life for around 500 million people worldwide.

Importance of HbA1c Measurement

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 complications of diabetes. It also aids in the appropriate follow-up of patients.

Limitations of Current Methods

The golden standard is an expert laboratory HPLC method focusing on HbA1c quantification. However, this method has limitations when other relevant hemoglobin variants need to be detected. For approximately 7% of the world’s population who are carriers of such hemoglobin variants, current methods lead to:

• Under-estimation of the HbA1c fraction
• Over-estimation of the HbA1c fraction
• Non-estimation of the HbA1c fraction

VortexLC Solution

VortexLC aims to improve the quality of the analysis to provide an instant full picture of the health status of diabetes patients. It will also produce a cost-effective point-of-care device.

Advantages of Vortex Flows

The use of vortex flows renders the approach compatible with mass manufacturing of plastic pillar array columns. These columns are:

1. Much cheaper than commonly used packed bed columns
2. Capable of achieving higher separation performances

Manufacturing Process

The polymer columns will be fabricated using several advanced techniques:

• UV-nanoimprint lithography
• Plasma technology to make them porous and add a chromatographic coating
• Lamination to close the column

All these processes can be scaled to roll-to-roll industrial manufacturing.

Instrumentation and Testing

The columns will be embedded in an instrument that allows for:

• Integrated sample preparation
• Miniaturized UV absorption and SERS detection

This setup will enable both quantification and identification of analytes.

Project Goals

In the project, a low footprint demonstrator of the novel system and columns will be built and tested with:

1. First synthetic samples
2. Next, human blood samples

The goal is to quantify HbA1c and its genetic variants.